@Article{info:doi/10.2196/83276,
author="Acquati, Chiara
and Aratow, Michael
and Nazreen, Tahmida
and Bhattacharjee, Arunima
and Marra, K. Isabella
and Alexander, S. Ashley",
title="Evaluating an AI-Enabled Mobile Mental Health Monitoring Tool Among Family Caregivers of Adults Living With Cancer: Single-Arm Feasibility and Acceptability Trial Protocol",
journal="JMIR Res Protoc",
year="2026",
month="Feb",
day="12",
volume="15",
pages="e83276",
keywords="cancer",
keywords="caregiving",
keywords="psychological distress",
keywords="speech-based monitoring",
keywords="artificial intelligence (AI)",
keywords="feasibility \& acceptability study",
keywords="mobile health (mHealth)",
keywords="acoustic analysis",
keywords="semantic analysis",
keywords="depression",
keywords="anxiety",
abstract="Background: Psychological distress, particularly symptoms of depression and anxiety (D\&A), is highly prevalent among family caregivers of individuals living with cancer, who often assume central roles in care coordination, treatment adherence, symptom monitoring, and emotional support. Rates of distress among caregivers frequently equal or exceed those observed in patients themselves. Despite increased attention to caregivers' mental health needs, routine distress screening remains limited in oncology care settings. Advances in mobile health technology and artificial intelligence (AI) offer opportunities to address these needs by providing accessible and user-driven tools. The Ellipsis Caregiver Assessment Enhancement (eCARE; Ellipsis Health, Inc) is a speech-based, AI-enabled mobile app designed to screen and monitor symptoms of depression and anxiety. By collecting brief voice recordings and in-app survey data, eCARE offers a scalable approach for integrating caregiver distress monitoring into cancer care. Objective: This single-arm trial will evaluate the feasibility and acceptability of the eCARE app among family members who are the primary caregivers of patients diagnosed with cancer within the past 5 years. Specifically, the study aims to (1) determine feasibility based on platform completion rates, (2) assess acceptability using validated measures, and (3) identify barriers and facilitators influencing the uptake and sustained use of eCARE. Methods: In Phase 1, a total of 60 United States--based family caregivers will be recruited from community health clinics, cancer and caregiving advocacy groups, and online postings. Screened and enrolled caregivers will complete 6 eCARE sessions over an 8-week period. Pre- and posttest surveys assess depression, anxiety, caregiving burden, and relational processes. Feasibility will be evaluated based on the proportion of participants who complete at least 66\% of weekly assessments, and acceptability will be assessed using the acceptability of intervention measure (AIM). In Phase 2, a total of 20 caregivers will be invited to participate in semi-structured online interviews to explore user experience, including perceived benefits, barriers to use, and preferences for future implementation. Qualitative data will be analyzed thematically to inform tool refinement. Results: The study has received Institutional Review Board approval from the University of Houston. Participant recruitment and enrollment began in June 2024, with data collection expected to conclude by August 2025. Data analysis will begin in December 2025, with preliminary results anticipated by May 2026. Conclusions: This study will generate preliminary evidence on the feasibility, acceptability, and utility of a speech-based, AI-enabled smartphone tool for monitoring D\&A symptoms among family cancer caregivers. Findings will inform the design of a larger, fully powered trial and guide future implementation of remote psychological distress monitoring strategies in oncology care. By offering a low-burden, caregiver-centered approach, eCARE has the potential to expand access to psychosocial support and facilitate timely identification of needs and coordination of services across cancer care settings. International Registered Report Identifier (IRRID): DERR1-10.2196/83276 ",
doi="10.2196/83276",
url="https://www.researchprotocols.org/2026/1/e83276"
}


@Article{info:doi/10.2196/86602,
author="Groba, Betania
and Concheiro-Moscoso, Patricia
and Miranda-Duro, Carmen Mar{\'i}a del
and Lagos-Rodr{\'i}guez, Manuel
and Pereira, Javier
and Nieto-Riveiro, Laura",
title="Enhancing Caregivers' Quality of Life Through a Web-Based Person-Centered Solution (TechQoL4Carers): Protocol for a Mixed Methods Pilot Trial",
journal="JMIR Res Protoc",
year="2026",
month="Feb",
day="5",
volume="15",
pages="e86602",
keywords="quality of life",
keywords="informal caregivers",
keywords="web-based platform",
keywords="wearable devices",
keywords="activities of daily living",
keywords="person-centered care",
abstract="Background: Informal care is a social challenge that impacts the daily life and quality of life (QoL) of caregivers. While care has evidence of positive aspects, it can also have negative impacts on mental, physical, economic, and social well-being. Nowadays, health, social, and care systems for informal caregivers are needed, from a person-centered perspective, to promote their QoL, health, and empowerment. Technology is a promising tool to provide personalized services. Objective: This study aims to develop an innovative care-centered technology solution to enhance caregivers' QoL, care impact, occupational balance, health self-management, and empowerment. Methods: A mixed methods pilot trial was designed as a single-arm open-label study. Participants will be caregivers of people with disabilities or older people, recruited through direct care centers. Caregivers will engage in a participatory process of developing, testing, and validating the TechQoL4Carers project platform, CuidaconTIC; a web-based platform to improve their QoL, impact of care, occupational balance, health self-management, and empowerment. The development of this trial will refine the CuidaconTIC platform, which is based on person-centered development, participatory design techniques, and an iterative process. A total of 54 caregivers will participate in a 3-month intervention involving the use of the CuidaconTIC platform and the Xiaomi Smart Band 7 wristband. Standardized assessment tools (EQ-5D-5L, Care-Related Quality of Life, Zarit Burden Interview, Caregiver Strain Index, Occupational Balance Questionnaire-Spanish Version, Psychological Empowerment Instrument, and the System Usability Scale) and a self-designed tool (Satisfaction-Q) will be used at 3 time points to collect information about usability, satisfaction, and project variables. Continuous information will be obtained from the platform (My week-Q) and the wearable wristband (physical activity and sleep). An interview will be conducted to gain in-depth knowledge about participants' perspectives. This study was approved by the Ethics Committee for Research and Teaching of the Universidade da Coru{\~n}a (2023\_019) and registered on ClinicalTrials.gov. Participation will be entirely voluntary, with informed consent obtained from each participant. Detailed information sheets and informed consent forms will be provided. The data of the participants will be collected in a pseudonymized form. Once the study has been completed, any possibility of participant identification will be eliminated. Results: Financial support for this project was received on December 1, 2022. This protocol was submitted after data collection but before analysis. Data collection began in May 2024 and ended in March 2025. By October 2025, 62 participants had been recruited. We expect to publish our results in June 2026. Conclusions: This protocol focuses on the study of the social challenge of quality of life of caregivers, mostly women, and on reducing the digital gap and promoting inclusion, through a service that places people and care at the center. Trial Registration: ClinicalTrials.gov NCT06226285; https://clinicaltrials.gov/study/NCT06226285 International Registered Report Identifier (IRRID): DERR1-10.2196/86602 ",
doi="10.2196/86602",
url="https://www.researchprotocols.org/2026/1/e86602"
}


@Article{info:doi/10.2196/86217,
author="Zhang, Jialing
and Wong, Ki Hoi
and Lin, Zhilin
and Zhong, Shuyan
and Ma, Minxia
and Wang, Xuejiao",
title="Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study",
journal="JMIR Res Protoc",
year="2026",
month="Jan",
day="23",
volume="15",
pages="e86217",
keywords="Traditional Chinese Medicine",
keywords="syndrome differentiation",
keywords="type 2 diabetes",
keywords="metabolic syndrome",
keywords="personalized treatment",
abstract="Background: The global burden of type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) continues to rise, with these conditions significantly increasing risks of cardiovascular disease, disability, and mortality. Traditional Chinese Medicine (TCM) syndrome differentiation, a cornerstone of TCM practice, guides diagnosis and treatment by identifying patterns of disharmony. However, large-scale studies investigating TCM syndrome patterns in T2DM comorbid with MetS remain scarce. Objective: This cross-sectional study aims to characterize TCM syndrome profiles in a population diagnosed with T2DM and MetS and evaluate their diagnostic relevance. Methods: This cross-sectional study will enroll a cohort of 470 participants diagnosed with T2DM and MetS. All participants will undergo comprehensive assessments, including the Syndrome Differentiation Questionnaire for T2DM and MetS, demographic and anthropometric measurements, biochemical profiling (eg, fasting glucose, glycosylated hemoglobin, and lipid panel), dietary measurement (Food Frequency Questionnaire), physical activity measurement (International Physical Activity Questionnaire Short Form), sleep quality evaluation (Pittsburgh Sleep Quality Index), quality-of-life assessment (Audit of Diabetes-Dependent Quality of Life), stroke risk estimation (Framingham Stroke Risk Score), and retinal imaging. Latent class analysis will be used to identify the TCM syndrome patterns. Factor analysis will be employed to identify core TCM syndrome factors. Hierarchical cluster analysis will be performed to classify TCM syndrome elements, and logistic regression will examine associations between syndrome differentiation, metabolic parameters, lifestyle factors, and disease progression. Results: This trial was registered on November 17, 2024. Participant recruitment for this study was initiated in November 2024. As of October 2025, more than 450 eligible participants have been enrolled and have completed data collection. Recruitment is scheduled to conclude on December 31, 2025. Conclusions: As the first large-scale clinical study to systematically characterize TCM syndrome differentiation in T2DM-MetS comorbidity, this research will establish syndrome profiles associated with metabolic parameters, lifestyle factors, and disease progression. The findings are expected to provide a framework for integrating TCM syndrome differentiation into chronic disease management, ultimately contributing to personalized treatment strategies and improved patient outcomes in integrative medicine. Trial Registration: ClinicalTrials.gov NCT06703684; https://clinicaltrials.gov/study/NCT06703684 International Registered Report Identifier (IRRID): DERR1-10.2196/86217 ",
doi="10.2196/86217",
url="https://www.researchprotocols.org/2026/1/e86217"
}


@Article{info:doi/10.2196/83980,
author="Richards, L. Veronica
and Braun, Ashlea
and Sladek, R. Michael
and Zhao, Junru
and Leffingwell, Thad
and Newell Chesebro, Sydney
and Croff, M. Julie",
title="Using Alcohol and Sleep Sensors to Understand Blackout Risk in Young Adults' Natural Settings (The Lights Out Study): Protocol for an Intensive Longitudinal Pilot Study",
journal="JMIR Res Protoc",
year="2026",
month="Jan",
day="21",
volume="15",
pages="e83980",
keywords="alcohol-induced blackout",
keywords="alcohol use",
keywords="cannabis",
keywords="college student",
keywords="ecological momentary assessment",
keywords="heavy drinking",
keywords="naturalistic research",
keywords="nicotine",
keywords="polysubstance use",
keywords="sleep",
keywords="wearables",
keywords="young adult",
abstract="Background: Alcohol-induced blackouts (AIBs) are a serious consequence of alcohol use that are strongly associated with experiencing excess alcohol?related harms. AIBs are common and recurrent among young adults who drink. The risk factors for AIBs include dynamics of alcohol use (quantity, speed, duration), alcohol-related behaviors (eg, playing drinking games, not using protective behavioral strategies), and factors related to the subjective experience of alcohol intoxication (eg, expectancies, motivations). Objective: This study seeks to examine 2 modifiable behaviors that have been shown to impact both alcohol consumption and subjective experiences of intoxication and may therefore be associated with AIB risk: (1) other substance use and (2) sleep. Methods: Approximately 50 participants will be recruited to participate in this study. Interested individuals will complete an online screening assessment, and those who are eligible (young adults who report recent heavy episodic drinking and AIBs) will be invited to an in-person baseline visit. At the baseline visit, participants will complete a baseline assessment, be fitted with a wrist-worn alcohol sensor (BACtrack Skyn) and a sleep or activity ring sensor (Oura ring), and receive training on the study protocol. Participants will complete a 14-day intensive data collection period consisting of twice daily scheduled mobile surveys and participant-initiated drinking surveys with hourly follow-ups. Participants will also wear the alcohol and sleep or activity sensors continuously during this 14-day period. After the intensive data collection period ends, participants will complete an in-person return visit to return their sensors, complete a follow-up survey, and receive compensation. The data will be processed and cleaned, and analyses will include multi-level structural equation models. Results: This study was funded in July 2025. Data collection is projected to span January 2026 through June 2026. Conclusions: This study seeks to understand 2 key modifiable behaviors that may be associated with increased AIB risk by leveraging multiple forms of innovative measurement. The integration of ecological momentary assessments with 2 sensors to capture alcohol use and sleep also supports potential applications in future digital interventions. This study will further enhance our preliminary data on the feasibility and acceptability of these methods, providing opportunities for conducting future research on a larger scale. ",
doi="10.2196/83980",
url="https://www.researchprotocols.org/2026/1/e83980"
}


@Article{info:doi/10.2196/83865,
author="Archibald, M. Mandy
and Wicklow, Brandy
and Sellers, Elizabeth
and Griffiths, Arlene
and Diffey, Linda
and McGavock, Jonathan
and Roos, E. Leslie
and Clark, M. Alexander
and Lopez, Jennifer
and Ho, Josephine
and Ledoux, Ernestine
and Dzorka, Gifty
and Parvin, Shahina
and Fagbuyi, Oluwatoyosi
and Dart, Allison",
title="A Virtual Living Lab Platform Codeveloped for Mental Health in Youth-Onset Type 2 Diabetes (BrightSpark Care Lab): Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2026",
month="Jan",
day="19",
volume="15",
pages="e83865",
keywords="type 2 diabetes",
keywords="mental health",
keywords="youth",
keywords="patient-centered research",
keywords="living labs",
keywords="arts-based knowledge translation",
abstract="Background: Type 2 diabetes (T2D) is a complex chronic disease that poses significant mental health challenges to affected youth. Despite calls for youth-centered research in this area, qualitative and mixed methods research is lacking, and longitudinal understandings of the mental health experiences of youth have not been generated. Living labs have potential as interactive knowledge exchange and longitudinal research platforms to generate such understandings. Objective: The proposed research aims to (1) codesign, with youth and parent coresearchers, a virtual living lab platform with an embedded registry of youth with T2D; (2) use this platform to generate longitudinal understandings of youths' mental health experiences; (3) identify youth priorities for research and care based on the thematic data; and (4) codesign an arts-based knowledge translation (KT) resource to communicate these priorities. Methods: This study proposes a three-stage longitudinal, qualitatively dominant, convergent mixed methods design. Stage 1 involved codesigning an online platform with youth and parent coresearchers over a 4-month period and establishing a user registry of English-speaking youth (age 10-25 years) with T2D (diagnosed at age 18 years or younger) in Canada and their parents or guardians. In stage 2, up to 50 youth were purposively selected from the registry to complete baseline mental health measures, followed by 12 content modules using diary and arts-based response methods. Inductive thematic and mixed methods analysis will inform stage 3. Up to a third of the stage 3 participants will be purposively selected to identify priorities for mental health research and care and codesign arts-based KT resources to impart critical research findings to stakeholder groups identified with participants and youth coresearchers. This is an experimental modality for data collection, and participant numbers may be fewer; however, methodological insights regarding engagement will be collated and published to support digital strategy in future work. Results: We recruited 4 youth coresearchers to codesign the BrightSpark online platform---Canada's first virtual living lab for youth and families with T2D---establishing an embedded registry of youth with T2D and creating the educational content of the 12 modules for the research. Recruitment and data collection began in March 2024 and concluded in September 2025. We anticipate study completion by January 2026. Conclusions: Youth-onset T2D presents a significant challenge to families and health systems, with less than 30\% of youth with T2D achieving treatment targets. Self-management in youth with T2D is further complicated by psychosocial morbidity, identity formation, stigma, blame, shame, historical oppression, and structural barriers to health. This study will contribute a sustainable and novel structure to understand this issue, providing opportunities to generate critically needed understandings of youths' mental health experiences to advance family-centered research and care. International Registered Report Identifier (IRRID): DERR1-10.2196/83865 ",
doi="10.2196/83865",
url="https://www.researchprotocols.org/2026/1/e83865"
}


@Article{info:doi/10.2196/79739,
author="Pope, C. Zachary
and Yabluchanskiy, Andriy
and Mukli, Peter
and Robertson, C. Michael
and Oliver, A. Jason
and Borengasser, J. Sarah
and Ratke, M. Meghan
and Matney, E. Jacob
and Mixon, Chris
and Henson, Christina
and Kellawan, Mikhail J.",
title="Smartphone-Based Physical Activity Program to Reduce ``Chemo-Brain'' Symptoms and Improve Health in Cancer Survivors With and Without Type 2 Diabetes: Protocol for a Single-Arm Pre-Post Pilot Trial",
journal="JMIR Res Protoc",
year="2025",
month="Dec",
day="10",
volume="14",
pages="e79739",
keywords="resistance training",
keywords="aerobic physical activity",
keywords="wearable technology",
keywords="smartphone applications",
keywords="social cognitive theory",
abstract="Background: The US cancer survivor population is projected to hit 26M by 2040. Chemotherapy is an effective cancer treatment, but can diminish cancer survivors' quality of life---particularly cognitive function---through select pathophysiological processes, including immune system and antioxidant dysregulation. The resulting cytokine release can impair cerebrovascular function---likely contributing to chemotherapy-induced cognitive impairment (CICI; ``chemo-brain''). Type 2 diabetes mellitus (T2DM)---a common cancer survivor comorbidity---shares underlying pathophysiology with CICI. Cancer survivors with T2DM might thus have a higher CICI risk than those without T2DM. Physical activity (PA) counteracts CICI's and T2DM's pathophysiology, but little to no research has been conducted assessing the impact of PA on this joint pathophysiology. Objective: To compare cerebrovascular and cognitive function as well as proinflammatory, cardiometabolic, epigenetic, and psychosocial outcomes between ancer survivors with and without T2DM pre- to postengagement in a 12-week technology-based PA program grounded in the Social Cognitive Theory. We hypothesize that cancer survivors with and without T2DM will demonstrate similar pre to poststudy improvements in psychosocial outcomes, but that changes in cerebrovascular and cardiometabolic outcomes, as well as PA engagement, will be greater for cancer survivors with T2DM. We also believe that each group will have distinct epigenetic profiles that will change pre to poststudy. Methods: We are conducting a 30-participant pilot study in cancer survivors with (n=15) and without (n=15) T2DM---all of whom report currently experiencing ``chemo-brain.'' To account for attrition, we are recruiting 38 cancer survivors from Oklahoma City, OK, and the surrounding area. Among the most important eligibility criteria are the self-report of cognitive difficulties following primary cancer treatment, being ?18 years old, being within 3 years of primary cancer treatment, and not meeting nationally recommended PA guidelines. Participants receive 2 smartphone apps. One smartphone app provides health education and the ability to set goals and journal about their wellness journey. The other provides a workout program continually tailored to each participant via their communication with the study exercise physiologist, with resistance bands and a wearable device provided to support the program. At Baseline and Poststudy, we assess cerebrovascular function (transcranial doppler [TCD]), cognition (National Institutes of Health Toolbox), cardiometabolic outcomes (venipuncture), and epigenetics (saliva collection). Participants also wear accelerometers at Baseline and Poststudy to objectively assess PA, with Baseline, Midpoint, and Poststudy surveys assessing psychosocial outcomes. We will use t tests and chi-square tests to assess baseline differences and repeated-measures ANCOVA to assess changes over time. Results: Participant recruitment started in March 2025, and we expect to recruit until late 2026. We will begin analyzing baseline data in 2026. Conclusions: Successful study completion will provide valuable insights into the remote delivery of PA-oriented supportive care for cancer survivors experiencing chemo-brain, as well as how T2DM and PA contribute to the mechanistic underpinnings of chemo-brain. Trial Registration: ClinicalTrials.gov NCT06725953; https://clinicaltrials.gov/study/NCT06725953 International Registered Report Identifier (IRRID): DERR1-10.2196/79739 ",
doi="10.2196/79739",
url="https://www.researchprotocols.org/2025/1/e79739"
}


@Article{info:doi/10.2196/85701,
author="Semciw, I. Adam
and Jessup, Rebecca
and Duckham, Rachel
and Gokhale, Swapna
and Gray, Hayley
and Bell, C. Emily
and Quick, M. Stephen
and Gentle, Juliette
and Phan, Uyen
and See, Katharine
and Galea-O'Neill, Rebecca
and Boyd, James
and Heng, Hazel
and Webster, Tracey
and King, G. Matthew",
title="Development of a Cocreated Perioperative Joint Replacement Digital Care Pathway to Improve Surgical Outcomes Following Joint Replacement: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2025",
month="Dec",
day="4",
volume="14",
pages="e85701",
keywords="arthroplasty",
keywords="rehabilitation",
keywords="co-design",
keywords="digital health",
keywords="patient education",
abstract="Background: Recently, perioperative care has gained attention for its ability to improve outcomes, reduce costs, and enhance patient satisfaction, especially when multidisciplinary support is involved. Despite these benefits, patient compliance remains low due to limited engagement in program design and practical barriers such as transportation, particularly for older adults. Co-designed digital health solutions offer a promising, scalable approach to delivering personalized, accessible perioperative care, with emerging evidence supporting their feasibility and effectiveness in patients who undergo joint replacement. Objective: The objectives of this study protocol are to outline the methods to address three study aims: (1) understand gaps and unmet needs, including knowledge, perceptions, barriers, and acceptability, during the perioperative patient journey of hip and knee arthroplasty; (2) co-create a novel patient-centric digital care pathway (DCP) that provides education and systematically captures patient-reported outcomes; and (3) evaluate the feasibility of implementation, appropriateness, and acceptability of the pathway when tested in patients undergoing nontraumatic hip and knee joint arthroplasty. Methods: This mixed methods co-design and implementation study will be conducted across 3 phases informed by the generative co-design framework for health care interventions. In phase 1 (predesign), patient interviews and journey mapping will be used to identify perioperative care gaps to be addressed in the DCP. In phase 2 (co-design), care gaps will be collaboratively framed, and iterative prototyping of the DCP will be conducted with consumer feedback and pilot testing. In phase 3 (evaluation), the feasibility of the DCP will be assessed using a previously reported framework. Inclusion criteria will vary across phases, focusing on people with lived experience or undergoing hip or knee joint replacement and relevant clinical or administrative staff. Results: The study was funded in September 2024, with phase 1 commencing in July 2025 and phase 2 in October 2025. Phase 3 is projected to commence before the end of 2025 and conclude 6 months later. As of October 2025, 13 people had been recruited, interviews were completed for phase 1, and recruitment for phase 2 had commenced. Conclusions: This protocol enhances methodological transparency by detailing the co-design approach, strengthening the evidence base, and supporting the development of a credible, transferable DCP. It addresses the lack of patient-centric perioperative programs in joint replacement care by incorporating individual needs and preferences. The digital format helps overcome access barriers, such as transport limitations, enabling patients to engage with the pathway anywhere. Additionally, patient-reported outcome measures collected through the DCP will improve understanding of recovery trajectories following hip and knee replacements. International Registered Report Identifier (IRRID): DERR1-10.2196/85701 ",
doi="10.2196/85701",
url="https://www.researchprotocols.org/2025/1/e85701"
}


@Article{info:doi/10.2196/78047,
author="Schiffer, Katharina
and Lippke, Sonia",
title="Improving Work-Related Challenges in Psychiatric-Psychosomatic Clinics: Study Protocol for an Internet-Based Needs Assessment and Co-Design of a Training",
journal="JMIR Res Protoc",
year="2025",
month="Nov",
day="25",
volume="14",
pages="e78047",
keywords="health care providers",
keywords="patient safety",
keywords="occupational well-being",
keywords="prevention \& control",
keywords="psychology",
abstract="Background: Medical, psychiatric-psychosomatic facilities are confronted with a variety of daily challenges that affect working conditions, the mental health of employees, and the quality of patient care. This project focuses on the work-related challenges faced by health care professionals in psychiatric-psychosomatic clinics in Germany. Objective: The aim of the current research is to investigate the interactions between individuals and their social environment, identify psychological and organizational challenges and job demands, and use these findings to inform the development of a participatory, evidence-based intervention. Methods: This 2-phase research is grounded in the job demands-resources model (JD-R). Study phase (needs assessment) uses a cross-sectional online survey with health care professionals in German psychiatric-psychosomatic clinics to assess job demands, resources, and outcomes in a target sample of N=600 participants (power analysis). Study phase 2 (co-design of a training) involves co-creatively designing an intervention based on survey findings through participatory workshops with at least N=20 participants. Analyses include regression and moderation tests (SPSS; IBM Corporation) and qualitative data analysis to co-design training. Results: The recruitment of participants is planned to be finished by December 2025. The co-designing of workshops (phase 2) will be started in February 2026. As this is a study protocol, results are not available yet. Conclusion: This current research examines the work-related challenges faced by health care professionals in psychiatric-psychosomatic clinics. It is expected that burnout, engagement, and psychological safety will likely emerge as central mediating and moderating variables. As the findings of phase 1 serve as a basis for the development of an intervention, this research seeks to improve the well-being of health care professionals in psychiatric-psychosomatic institutions sustainably. Trial Registration: ClinicalTrials.gov NCT06867601; https://clinicaltrials.gov/study/NCT06867601 International Registered Report Identifier (IRRID): PRR1-10.2196/78047 ",
doi="10.2196/78047",
url="https://www.researchprotocols.org/2025/1/e78047"
}


@Article{info:doi/10.2196/72548,
author="Honisett, Suzy
and Lingam, Raghu
and Eapen, Valsamma
and Oldenburg, Brian
and Hackworth, Naomi
and Hiscock, Harriet
and Charalambous, George
and Minton, Lisa
and Pringle, Glenn
and Woolfenden, Sue
and Dalziel, Kim
and Eastwood, John
and Goldfeld, Sharon",
title="A Novel Digital Platform to Support Child and Family Mental Health in Australia (Child and Family eHub): Protocol for a Mixed Methods Evaluation",
journal="JMIR Res Protoc",
year="2025",
month="Nov",
day="13",
volume="14",
pages="e72548",
keywords="child mental health",
keywords="consumer health information",
keywords="child health services",
keywords="digital health technology",
keywords="family supports",
abstract="Background: Child mental health disorders are a significant Australian public health issue with high prevalence rates compounded by inequitably higher rates for those living in families with lower income, lower levels of parental education, and higher levels of unemployment. Prevention and early intervention approaches are critical to address problems early. When caregivers seek information and services to support their child's mental health needs, they commonly use many untested online search strategies. To address this, we developed a digital Child and Family eHub (eHub) prototype through a user-centered design process involving families experiencing adversity and local service providers. The eHub provides online navigation and evidence-based information for families and aims to increase equitable access to and use of (1) information and (2) the existing primary health, mental health, and social services system to improve mental health outcomes for caregivers with children aged 0-12 years. This protocol outlines how we will evaluate the eHub. Objective: This study aims to evaluate the feasibility, acceptability, appropriateness, and preliminary impact of the eHub digital platform for caregivers of children aged 0-12 years, particularly those experiencing adversity. The evaluation will assess implementation outcomes, caregiver and child mental health outcomes, and help-seeking behaviors over a 6-month period. Methods: A prospective cohort of 270 caregivers of children aged 0-12 years will be recruited from 3 socioeconomically diverse Australian sites (Wyndham Vale in Victoria and Marrickville and Fairfield in New South Wales). Participants will be recruited through local community hubs, health and social service providers, and social media, and will enroll via the REDCap (Research Electronic Data Capture; Vanderbilt University) survey platform. A mixed methods type 3 implementation impact evaluation will be undertaken, which tests an implementation strategy while observing and gathering information on the intervention's impact on relevant outcomes. In this protocol, implementation will be assessed as a primary outcome using Proctor's outcomes for the implementation framework, and secondary outcomes will include caregiver access and use of the eHub and associated child and parent mental health outcomes. Data will be collected at baseline and 6 months. Quantitative data will be analyzed using descriptive statistics and regression models; repeated measures will be analyzed using generalized estimating equations. Qualitative data will be analyzed using framework analysis. Results: The study was funded in December 2021. Participant enrollment for the study began in February 2024, with participants involved in the eHub evaluation for 6 months. Conclusions: The results of this study will be instrumental in refining the intervention for future scaling to other Australian sites. This study has the potential to offer an accessible, cost-effective, and scalable digital solution to improve service navigation and mental health outcomes for children and families experiencing adversity. Trial Registration: ISRCTN Registry ISRCTN49839991; https://doi.org/10.1186/ISRCTN49839991 International Registered Report Identifier (IRRID): DERR1-10.2196/72548 ",
doi="10.2196/72548",
url="https://www.researchprotocols.org/2025/1/e72548"
}


@Article{info:doi/10.2196/73766,
author="Caro, Carlos Juan
and Nguyen, H. Phuong
and Lipman, Stefan",
title="Automated Personalized Goal Setting for Individual Exercise Behavior: Protocol for a Web-Based Adaptive Intervention Trial",
journal="JMIR Res Protoc",
year="2025",
month="Nov",
day="12",
volume="14",
pages="e73766",
keywords="contextual bandits",
keywords="behavior change",
keywords="adaptive experiments",
keywords="personalized exercise",
keywords="machine learning",
keywords="user autonomy",
abstract="Background: The incidence of chronic diseases associated with physical inactivity is on the rise, being one of the leading risk-increasing factors for early death rates throughout the world. Often, physical activity interventions fail to deliver sustained adherence over time due to limiting tailoring to individual baseline characteristics, leaving out contextual changes over time. One solution for this issue may be the use of adaptive interventions relying on contextual multiarmed bandits, a type of reinforcement learning algorithm, that can use baseline and contextual individual data to personalize aspects of the intervention, such as developing personalized workout plans. Objective: The main objectives of this study are (1) to determine the effectiveness of contextual bandits for automated goal setting in the context of a web-based physical activity intervention, (2) to understand the role of user characteristics impacting ideal workout schedules based on adherence to predetermined goals, and (3) to explore the influence of user autonomy on recommendation effectiveness. Methods: We developed a protocol for a web-based adaptive intervention trial to investigate the effectiveness of goal recommendation (task difficulty) based on reinforcement learning. The web application (named Apptivate) creates workout routines with 3 different difficulty levels, changing the total workout duration as well as rest times between exercises. Physical activity professionals validated the routine design, ensuring that workouts match recommended guidelines for healthy adults. An initial pilot was conducted, aiming for 800 university students to test the web application for 1 week, to provide initial data to calibrate the algorithm as well as overall feedback for the web application. For the main study, a total of 500 university students will be recruited to participate for 40 days during early 2026. Participants will be divided into 3 groups: user choice (no recommendation), user choice with automated recommendations (contextual bandits), and automated plans without choice. Results: The pilot was conducted in September 2025. Data analysis for the pilot is undergoing, and the main study is planned for early 2026. Our main statistical analysis includes a direct comparison (paired tests) between success rates across intervention arms, as well as by difficulty level and individual characteristics. Conclusions: Physical activity maintenance is key to achieving long term health goals. Tailored digital interventions are promising strategies for physical activity adherence, but personalization often fails to consider dynamic contextual changes. The proposed protocol for a physical activity intervention using adaptive experimentation can provide robust causal inference on the role of choice versus autonomy when goal difficulty is tailored under an adaptive data-driven approach. International Registered Report Identifier (IRRID): PRR1-10.2196/73766 ",
doi="10.2196/73766",
url="https://www.researchprotocols.org/2025/1/e73766"
}


@Article{info:doi/10.2196/81421,
author="Ramsay, G. Angus I.
and Sherlaw-Johnson, Chris
and Herbert, Kevin
and Bagri, Stuti
and Bodea, Malina
and Crellin, Nadia
and Elphinstone, Holly
and Halliday, Amanda
and Hemmings, Nina
and Lawrence, Rachel
and Lobont, Cyril
and Ng, Li Pei
and Lloyd, Joanne
and Massou, Efthalia
and Mehta, Raj
and Morris, Stephen
and Shand, Jenny
and Walton, Holly
and Fulop, J. Naomi",
title="Implementation, Experiences, Impact, and Costs of Artificial Intelligence in Chest Diagnostics: Protocol for a Mixed Methods Evaluation",
journal="JMIR Res Protoc",
year="2025",
month="Oct",
day="31",
volume="14",
pages="e81421",
keywords="artificial intelligence",
keywords="diagnostic imaging",
keywords="lung cancer",
keywords="mixed methods evaluation",
keywords="patient outcomes",
keywords="cost-effectiveness",
keywords="patient experience",
abstract="Background: The ability to perform complex tasks has seen artificial intelligence (AI) used to support radiology in clinical settings, including lung cancer detection and diagnosis. Evidence suggests that AI can contribute to accurate diagnosis, reduce errors, and improve efficiency. The National Health Service England (NHSE)--funded Artificial Intelligence Diagnostic Fund (AIDF) is currently supporting 12 National Health Service (NHS) networks to implement AI for chest diagnostic imaging. There is, however, limited evidence on real-world AI implementation and use, including staff, patient, and caregiver experience, and costs and cost-effectiveness. A National Institute for Health and Care Research Rapid Service Evaluation Team Phase 1 evaluation provided insights into the early implementation of these tools and developed a framework for monitoring and evaluation of AI tools for chest diagnostic imaging in practice. Objective: This mixed methods evaluation of AI tools for chest diagnostic imaging aims to address previous research gaps by exploring the implementation of AI tools for chest diagnostic imaging, the impact and costs of implementing these service models, and the experiences of patients, caregivers, and staff. Methods: This study will be a mixed method evaluation of implementation, experiences, impact, and costs of AI for chest diagnostic imaging in NHS services in England, with the evaluation informed by the Major System Change Framework. Trust-level case studies (3 in-depth and up to 9 light-touch) will be performed, including staff member, patient, and caregiver; NHSE AIDF team interviews; meeting observations; and analysis of key relevant documentation. Qualitative data will be analyzed using Rapid Assessment Procedures and inductive thematic analysis, supplemented by in-depth deductive thematic analysis. Data from case study sites and other relevant sources will be used to assess outcomes at the other sites and for comparators. A pragmatic economic model of the chest diagnostic imaging pathway will be developed to estimate key costs and resource use associated with AI tool deployment. Together with input from national stakeholders and staff workshops, the study findings will then be finalized for reporting. Results: As of September 2025, trust-level research and development approvals with participating sites are complete, and data collection has commenced. Results are expected to be reported by the end of February 2026. Conclusions: The study will provide new insights into the facilitators and barriers to the adoption of AI technology in health care and the perceptions of both the general public and health care staff on its use. It will also inform best practices in approaches for service performance evaluation, for the implementation of AI into existing care pathways, and for the development of models to best support evidence-based decision-making. It will thus establish a framework upon which the greatest benefits of the use of AI in health care can be realized. International Registered Report Identifier (IRRID): DERR1-10.2196/81421 ",
doi="10.2196/81421",
url="https://www.researchprotocols.org/2025/1/e81421"
}


@Article{info:doi/10.2196/75065,
author="Donoso-Hofer, Francisca
and Carrasco Soto, Rolando
and Cornejo Ovalle, Marco
and Mart{\'i}n, Conchita",
title="Facial Feminization Surgery and Quality of Life in Transgender Women: Protocol for a Cohort Study",
journal="JMIR Res Protoc",
year="2025",
month="Oct",
day="28",
volume="14",
pages="e75065",
keywords="facial feminization surgery",
keywords="transgender health",
keywords="quality of life",
keywords="cephalometry",
keywords="gender-affirming care",
keywords="Latin America",
keywords="psychometric validation",
abstract="Background: Transgender women face significant health inequities. Facial feminization surgery is an intervention that aligns craniofacial structures with female anatomical norms and gender identity. Although international studies suggest that facial feminization surgery improves psychosocial outcomes, most studies have focused on aesthetic results or relied on generic quality-of-life instruments that have not been validated for this population. In Chile, no study has evaluated the multidimensional impact of facial feminization surgery using patient-centered measures combined with objective cephalometric and photometric analyses. Moreover, no validated Spanish-language quality-of-life instrument exists for transgender women undergoing this surgery. Objective: This study aims to (1) develop and validate a culturally appropriate quality-of-life questionnaire for transgender women undergoing facial feminization surgery in Chile, and (2) evaluate postoperative changes in quality of life, perception of facial femininity, and cephalometric and photometric parameters. Methods: The study will include 2 methodological phases: a cross-sectional validation study and a longitudinal cohort study. Phase 1 involves questionnaire development and validation, following the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) guidelines, with a systematic literature review conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, expert panel content validation, pilot testing, and psychometric evaluation in a cohort of ?200 transgender women. Phase 2 is a longitudinal cohort study conducted at San Juan de Dios Hospital in Santiago, Chile, following the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines. Thirty transgender women scheduled for facial feminization surgery will be assessed at baseline and 12 months postoperatively. Outcomes include quality of life, self-perceived and third-party--rated femininity, and cephalometric and photometric changes (using cone beam computed tomography). Data analyses include exploratory and confirmatory factor analyses, Cronbach $\alpha$, paired 1-tailed t tests or Wilcoxon signed-rank tests, chi-square or Fisher tests, and linear regression models. Results: This study was funded in October 2023. Phase 1 (January 2024 to January 2025) included 216 participants, exceeding the minimum sample size requirement. Data analysis is ongoing, and results will be reported separately. Phase 2 is in progress, with preoperative cone beam computed tomography scans and photographs being collected. The validated preoperative questionnaire will be administered in late 2025, with surgeries scheduled throughout 2026. Data collection is expected to conclude in 2027. Conclusions: This protocol addresses a critical evidence gap in Latin America by integrating psychometric validation and longitudinal evaluation of facial feminization surgery outcomes among transgender women in Chile. The project is expected to develop the first validated Spanish-language quality-of-life instrument specific to facial feminization surgery, alongside multidimensional evidence of surgical outcomes. The findings will inform clinical decision-making, contribute to inclusive patient-centered care, and support the development of evidence-based policies for transgender health in the region. International Registered Report Identifier (IRRID): DERR1-10.2196/75065 ",
doi="10.2196/75065",
url="https://www.researchprotocols.org/2025/1/e75065"
}


@Article{info:doi/10.2196/64801,
author="Zahrai, Amin
and Bisson, J. Etienne
and Shergill, Yaadwinder
and Rice, Danielle
and Zur Nedden, Natalie
and Cooper, Lynn
and James, Daniel
and Rash, A. Josh
and Bosma, Rachael
and Ramsay, Tim
and Poulin, Patricia",
title="Implementation and Effectiveness of the Power Over Pain Portal for Patients Awaiting a Tertiary Care Consultation for Chronic Pain: Protocol for a Pilot, Prospective, Cohort, Mixed Methods Study",
journal="JMIR Res Protoc",
year="2025",
month="Sep",
day="25",
volume="14",
pages="e64801",
keywords="chronic pain",
keywords="self-management",
keywords="patient portal",
keywords="virtual care",
keywords="mental health",
keywords="substance use",
keywords="implementation science",
keywords="feasibility study",
keywords="protocol",
keywords="online",
abstract="Background: Chronic pain (CP) affects approximately 8 million people in Canada. Access to CP care is challenging, and there is no robust monitoring system to support patient care and decision-making. The Power Over Pain (POP) Portal was developed by people living with CP, health care providers, researchers, health system decision-makers, policymakers, and community partners to address these concerns. The POP Portal is a comprehensive web-based platform that provides rapid access to a continuum of free, evidence-informed resources for the self-management of CP, mental health, and substance use health. The POP Portal also offers self-assessment tools that enable users to track their progress and receive personalized recommendations. Objective: This hybrid implementation-effectiveness type III pilot study aimed to determine the feasibility (ie, recruitment, integration, facilitators and barriers, patient engagement, usability, and acceptability) of the POP Portal's implementation for people waiting for care at a tertiary pain clinic. Methods: A cohort of 80 adults living with pain was recruited from the waitlist of a tertiary care pain clinic over a 3-month period. Following an orientation on the POP Portal, participants were encouraged to use it according to their needs and preferences. They were also asked to complete questionnaires at baseline (0 months) and the 3-month follow-up. Primary feasibility measures included recruitment and retention rates and portal acceptability using the Acceptability E-scale. We also measured usability using the System Usability Scale, evaluated engagement through portal analytics, and identified facilitators and barriers via semistructured interviews with 12 to 15 study participants. These interviews further assessed the acceptability and usability of the portal for participants. Exploratory measures included pain severity, pain-related interference, self-efficacy, coping strategies, and symptoms of anxiety and depression. Results: We will present descriptive data on the cohort's sex and gender, age, rural or urban status, and ethnic background, as well as the acceptability, usability, and feasibility of the portal. Measures of central tendency will be reported for continuous variables, and frequencies and proportions will be reported for categorical variables. We will also present change in clinical outcomes across time and a synthesis of qualitative and thematic data. Conclusions: We anticipate that most patients awaiting care at a tertiary pain clinic recruited will use the POP Portal and find it to be acceptable for addressing some of their pain and associated health concerns. If the feasibility of recruiting and retaining patients is demonstrated as anticipated, we will be able to move forward with a multisite study to evaluate the implementation and effectiveness of the POP Portal among patients waiting for a tertiary care consultation. International Registered Report Identifier (IRRID): DERR1-10.2196/64801 ",
doi="10.2196/64801",
url="https://www.researchprotocols.org/2025/1/e64801"
}


@Article{info:doi/10.2196/67697,
author="Rampidis, Georgios
and Logaras, Evangelos
and Samaras, Athanasios
and Rigas, S. Emmanouil
and Kyparissidis-Kokkinidis, Ilias
and Siakopoulou, Styliana
and Kartsidis, Panagiotis-Emmanouil
and Kouskouras, Konstantinos
and Giannakoulas, George
and Bamidis, Panagiotis
and Billis, Antonios",
title="Clinical Performance Evaluation of an Artificial Intelligence--Based Tool for Predicting the Presence of Obstructive Coronary Artery Disease: Protocol for a Cohort Observational Study",
journal="JMIR Res Protoc",
year="2025",
month="Sep",
day="25",
volume="14",
pages="e67697",
keywords="coronary computed tomography angiography",
keywords="CCTA",
keywords="CAD",
keywords="coronary artery disease",
keywords="cardiology",
keywords="stenosis prediction",
keywords="AI",
keywords="protocol",
keywords="ML",
keywords="machine learning",
keywords="artificial intelligence",
abstract="Background: A significant number of individuals undergoing coronary computed tomography angiography (CCTA) for suspected (CAD) have nonobstructive or no CAD. There is a need for clinically proven models that can predict the pretest probability of stable CAD and help to identify low-risk individuals. Optimizing patient stratification is of paramount importance to improve diagnostic yield and cost-effectiveness. Objective: We aimed to determine whether each patient needs to undergo CCTA because of suspected CAD. The main objective of this study is to evaluate the clinical performance of an artificial intelligence (AI)-based tool in predicting significant coronary artery stenosis (>50\%), as well as its utility by medical professionals. Methods: Data for this study have been acquired from 750 participants as part of routine clinical practice in AHEPA (American Hellenic Educational Progressive Association) General Hospital of Thessaloniki. The dataset has several features, including demographics (eg, age, gender), medical history (eg, diabetes mellitus, arterial hypertension), and clinical variables (eg, creatinine, epicardial fat volume). At least 2 expert cardiologists and 2 expert radiologists are involved in this study, who provide the ground truth. A trained AI-based model embedded in an easy-to-use and user-friendly web application is implemented in practice. Several AI algorithms are being examined, and the model found to perform best so far is the Optimized Voting model, which is a combination of the best performing iterations of random forest and extreme gradient boosting. The performance metrics that are being used are accuracy, precision, recall, F1-score, area under the receiver operating characteristic curve, and area under the precision-recall curve. Results: Recruitment for this study began in July 2023. Data collection, development, training, and deployment of the AI web tool were completed by May 2024. In total, data from 500 individuals were collected for training and internal validation, while the best performing model was validated externally in another 250 individuals. For training and internal validation, the dataset was split into 70\% for training and 20\% for validation and 10\% for testing. Currently, the best performing model achieves an accuracy of approximately 82\% in successfully predicting stenosis greater than 50\%. Additionally, an explainable AI algorithm is used to provide explanations in relation to the decisions made aiming to increase the trust of the clinicians in the tool. Conclusions: The proposed study represents a novel approach of a web-based AI-driven solution with explainability features for optimizing patient stratification with the goal of improving diagnostic yield and cost-effectiveness of CCTA utilization within the context of cardiology clinical practice. International Registered Report Identifier (IRRID): DERR1-10.2196/67697 ",
doi="10.2196/67697",
url="https://www.researchprotocols.org/2025/1/e67697"
}


@Article{info:doi/10.2196/74408,
author="P{\'e}rez, Jes{\'u}s
and Heredero Jung, David
and Gonzalo, {\'O}scar
and Garc{\'i}a Berrocal, Bel{\'e}n
and Garc{\'i}a Cerd{\'a}n, Carmen
and Salas Aranda, Pablo
and de la Sota P{\'e}rez, Alejandro
and Lorenzo Hern{\'a}ndez, Milagros Sandra
and Marcos Vadillo, Elena
and Garc{\'i}a Garc{\'i}a, Roc{\'i}o
and Berdi{\'o}n Marcos, Vanesa
and Maci{\'a} Casas, Ana
and Refoyo Matell{\'a}n, Bel{\'e}n
and Bote Bonaechea, Berta
and Garc{\'i}a Ull{\'a}n, Llanyra
and Lorenzo Romo, Carolina
and Mart{\'i}n G{\'o}mez, Carmen
and Turri{\'o}n G{\'o}mez, Concha
and Isidoro Garc{\'i}a, Mar{\'i}a",
title="Clinical Utility of Early Intervention Including the 5-Step Precision Medicine Method in First-Episode Psychosis: Protocol for a Cohort Study With Nested Economic and Process Evaluations",
journal="JMIR Res Protoc",
year="2025",
month="Sep",
day="23",
volume="14",
pages="e74408",
keywords="first-episode psychosis",
keywords="early intervention",
keywords="precision medicine",
keywords="personalized precision psychiatry",
keywords="antipsychotics",
keywords="schizophrenia",
abstract="Background: Psychotic disorders such as schizophrenia present a significant challenge to health care systems due to their high disability rates and treatment costs. With discontinuation rates for antipsychotics reaching over 40\% in the first year and 80\% after 3 years, it is crucial to tailor antipsychotic selection and dosing early in treatment. Personalized precision psychiatry, underpinned by pharmacogenetics, holds considerable potential in individualizing antipsychotic treatment for patients with first-episode psychosis. An internationally pioneering method called 5-step precision medicine (5SPM) focuses on the application of pharmacogenetics to clinical practice. The recently launched Prevention and Early Intervention in Mental Health (PRINT) program in Salamanca, Spain, integrates this method to enhance early intervention for adolescents and young people with first-episode psychosis. Objective: The Clinical Utility of Early Intervention Including the 5SPM Method in First-Episode Psychosis (CLUMP) project aims to explore whether an early intervention model of personalized precision psychiatry including pharmacogenetics improves adherence to antipsychotic medicines and, therefore, clinical and functional outcomes in young people experiencing the first episode of a psychotic illness. Methods: To achieve our objectives, we shall compare adherence to the first prescribed antipsychotic medication and clinical and functional outcomes between patients with first-episode psychosis. We shall compare 2 cohorts: cohort 1 will receive the recently introduced PRINT program including the 5SPM method, and cohort 2 will have received standard care provided by mental health services before the PRINT program implementation. The primary outcome to measure treatment adherence will be all-cause discontinuation proportions during the 1-year follow-up. Secondary outcome measures will include pragmatic efficacy, tolerability, and functional outcome measures. For additional comparative purposes, we shall analyze the environmental, clinical, and pharmacogenetic information of patients with psychotic disorders of more than 5 years of evolution and with other mental disorders whose data are currently stored and have been ethically approved for research use. A total of 300 patients will be included in the study. Analyses will include descriptive statistics, comparison tests, Kaplan-Meier survival curves, multivariate log rank tests, qualitative analysis, and cost-benefit evaluation. Results: Ethics approval was obtained in June 2023. Recruitment for the CLUMP project began in January 2025, and enrollment for cohort 1 will continue until May 2026. All data collection is expected to be completed by June 2027. Data analyses are estimated to take approximately 6 months. The project is scheduled to conclude in December 2027. Conclusions: The CLUMP project is set to provide the first clear blueprint for implementing and evaluating the impact of personalized precision psychiatry based on pharmacogenetics in the context of early intervention programs for the benefit of young people experiencing the first episode of a severe mental illness such as schizophrenia. International Registered Report Identifier (IRRID): DERR1-10.2196/74408 ",
doi="10.2196/74408",
url="https://www.researchprotocols.org/2025/1/e74408"
}


@Article{info:doi/10.2196/65811,
author="Wahyudi, Irfan
and Utomo, Prasetyo Chandra
and Djauzi, Samsuridjal
and Fathurahman, Muhamad
and Situmorang, Reinaldi Gerhard
and Rodjani, Arry
and Raharja, Risky Putu Angga
and Yonathan, Kevin
and Santoso, Budi
and Khresna, Dwidian
and Raditya, Marco",
title="Deep Learning--Based Pattern Recognition for Detecting Penile Abnormalities: Protocol for Developing a Mobile App for Circumcision Eligibility",
journal="JMIR Res Protoc",
year="2025",
month="Sep",
day="10",
volume="14",
pages="e65811",
keywords="circumcision",
keywords="artificial intelligence",
keywords="penile abnormalities",
keywords="mobile app",
keywords="prospective cohort study",
abstract="Background: Circumcision is a widely practiced procedure with cultural and medical significance. However, certain penile abnormalities---such as hypospadias or webbed penis---may contraindicate the procedure and require specialized care. In low-resource settings, limited access to pediatric urologists often leads to missed or delayed diagnoses. Artificial intelligence (AI)--based image recognition presents a scalable solution to facilitate early detection and informed decision-making. Objective: This study aims to develop and validate an AI-powered image classification system integrated into a mobile app to detect penile abnormalities and assess circumcision eligibility. The system is designed to support preliminary screening by general practitioners and caregivers in underserved areas. Methods: A prospective cohort study was conducted involving pediatric patients at Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Digital images will be collected prospectively from pediatric patients at Cipto Mangunkusumo Hospital captured by health care professionals or caregivers. High-resolution penile images were systematically captured from ventral, dorsal, and lateral angles and subsequently classified as either having normal or abnormal anatomy by urologists. Leveraging pretrained deep learning architectures, the AI models were developed to accurately classify these images and assess circumcision eligibility based on anatomical criteria. Image preprocessing included resizing, normalization, and augmentation. Transfer learning techniques were used to enhance accuracy. The model was developed using TensorFlow and Keras. Performance evaluation used accuracy, sensitivity, specificity, and F1-score. Following development, the model will be embedded into a mobile app to enable real-time analysis, with feedback on whether further clinical evaluation or referral is needed. Results: Model development began in January 2024 and is currently ongoing. Integration into the mobile app and deployment testing are scheduled across 3 sequential phases---refinement, integration, and user testing---through January 2026. Preliminary models have been trained, and refinement is underway to improve diagnostic accuracy and usability. Conclusions: The proposed AI-based system offers a promising tool to support early diagnosis of penile abnormalities and safe circumcision decision-making in resource-limited settings. Its integration into a mobile app enables preliminary screening outside specialized centers, facilitating telemedicine and optimizing referral pathways. International Registered Report Identifier (IRRID): DERR1-10.2196/65811 ",
doi="10.2196/65811",
url="https://www.researchprotocols.org/2025/1/e65811"
}


@Article{info:doi/10.2196/71839,
author="Lovette, C. Brenda
and Bakhshaie, Jafar
and Kulich, Ronald
and Shaefer, R. Jeffry
and Cheng, Thomas Hsinlin
and He, Shuhan
and Vranceanu, Ana-Maria
and Greenberg, Jonathan",
title="Development of a Novel Web-Based Intervention Targeting Pain-Related Outcomes in Individuals With Chronic Orofacial Pain: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2025",
month="Aug",
day="20",
volume="14",
pages="e71839",
keywords="chronic orofacial pain",
keywords="mind-body",
keywords="psychosocial",
keywords="web-based platform",
keywords="asynchronous",
abstract="Background: Chronic orofacial pain (COP) is common, costly, and associated with substantial pain interference and emotional distress. Psychosocial treatments for COP are scarce and limited (eg, rely on talking, which is often painful for this population; require intensive resources, limiting scalability). Here, we describe the study protocol for developing Face-Forward-Web, a ``talk-free'' web-based mind-body intervention for patients with COP. Objective: We aim to (1) develop Face-Forward-Web with the aid of live-video focus groups with adults with COP and (2) optimize Face-Forward-Web and our study protocol through beta testing followed by an open feasibility trial. Methods: We will accomplish these aims in 2 phases, incorporating user-centered design principles. For phase 1, we conducted semistructured focus groups (n=4 groups, 22 participants) with individuals with COP. We are using rapid data analysis followed by thematic analysis to gauge treatment needs, preferences, and perceptions of the proposed platform and skills. This information will inform session structure and content as well as development of a wireframe followed by a prototype. For phase 2, we will conduct beta testing (up to n=10) followed by a feasibility trial (up to n=20) with exit interviews to gather feedback. The primary outcomes are feasibility benchmarks such as recruitment (?70\% of the eligible participants will participate), acceptability (?70\% of the participants complete ?4 or 5 sessions), credibility, expectancy (?70\% above the Credibility and Expectancy scale's midpoint), and satisfaction (?70\% above the User Experience Questionnaire's midpoint). Results: Recruitment for phase 1 began in October 2024 and concluded in January 2025. Data analysis for phase 1 will conclude in fall 2025 and for phase 2 in 2026. Results will iteratively guide the development of the intervention. Conclusions: Face-Forward-Web will be the first talk-free web-based intervention tailored to the needs of adults with COP. Results will inform a future efficacy trial. Trial Registration: ClinicalTrials.gov NCT06754917; https://clinicaltrials.gov/study/NCT06754917 International Registered Report Identifier (IRRID): DERR1-10.2196/71839 ",
doi="10.2196/71839",
url="https://www.researchprotocols.org/2025/1/e71839"
}


@Article{info:doi/10.2196/66317,
author="Franklin, E. Brooke
and Meulenberg, L. Brynn
and Beaulieu, Z. Elizabeth
and Cisneros-Macias, Jessica
and Cao, Yiqing
and Carbajal-Salisbury, Sara
and Villalta, Jeannette
and Flores, Nelamaria
and Fuentes, Virginia
and Hernandez, C. Maria
and Parry-Alba, Diana
and Rodriguez, Carmen
and Rodriguez, Yolanda
and Zavala Orozco, S. Veronica
and Asnaani, Anu
and Sanchez-Birkhead, Ana
and Baucom, W. Katherine J.",
title="``PrevenganT2,'' a Culturally Responsive Family-Based Diabetes Prevention Intervention for Hispanic or Latino Adults at High Risk for Type 2 Diabetes: Protocol for a Proof-of-Concept Evaluation",
journal="JMIR Res Protoc",
year="2025",
month="Aug",
day="14",
volume="14",
pages="e66317",
keywords="community-based participatory research",
keywords="cultural adaptation",
keywords="family-based diabetes prevention",
keywords="family support",
keywords="health behavior change",
keywords="Hispanic or Latino",
keywords="lifestyle intervention",
keywords="type 2 diabetes",
abstract="Background: Despite the efficacy of lifestyle interventions for preventing or delaying diabetes, community translations to date have failed to engage Hispanic or Latino participants effectively. Previously identified barriers to engagement include lack of family support and the burden of time-intensive year-long programs. Integrating family members and reducing program length may have the potential to increase engagement in lifestyle interventions to prevent type 2 diabetes in Hispanic or Latino individuals. Objective: Given the potential impact of cultural adaptation on such interventions, our community-academic research team used the Obesity-Related Behavioral Intervention Trials (ORBIT) model to guide an adaptation of the core 16 modules of the National Diabetes Prevention Program's PrevengaT2 curriculum to meet the needs of Hispanic or Latino communities in Utah. We describe our evaluation of this adaptation in an ongoing proof-of-concept trial. We will evaluate whether Hispanic or Latino participants at high risk for type 2 diabetes increase their weekly moderate-to-vigorous physical activity (MVPA) in the context of an ongoing proof-of-concept trial of the adaptation. Methods: Target participants at risk for type 2 diabetes and a family member were invited to participate in PrevenganT2. In earlier phases of a larger project, our academic-community research team created the 14-week lifestyle intervention by adapting the Centers for Disease Control and Prevention's PrevengaT2 curriculum. Objective MVPA was measured for 7 days at preintervention and postintervention using ActiGraph GT3X-BT accelerometers. Participants additionally completed questionnaires at preintervention and postintervention, and weight and self-reported MVPA were recorded at lifestyle intervention classes. Physical activity data will be analyzed to determine the percentage of target participants with clinically significant pre-post increases in MVPA. Results: Data collection concluded in October 2024. Data cleaning and preparation for analysis are ongoing. We expect that results will be submitted for publication by June 2025. Conclusions: This study serves as a first step in evaluating a novel, culturally adapted lifestyle intervention to prevent type 2 diabetes in Hispanic or Latino adults. Although this small study is not without limitations, findings will inform our team's next steps for this early-phase intervention work. International Registered Report Identifier (IRRID): DERR1-10.2196/66317 ",
doi="10.2196/66317",
url="https://www.researchprotocols.org/2025/1/e66317"
}


@Article{info:doi/10.2196/65105,
author="Hartz, Jacob
and Chiert, Hannah
and de Ferranti, Sarah
and Powell-Wiley, Tiffany",
title="The Use of Mobile Health Technology and Behavioral Economics to Encourage Adherence to Statins and Blood Pressure--Lowering Medication in Adolescents with Familial Hypercholesterolemia or Hypertension: Protocol for a Pre-Post Cohort Study",
journal="JMIR Res Protoc",
year="2025",
month="Aug",
day="14",
volume="14",
pages="e65105",
keywords="dyslipidemia",
keywords="hypertension",
keywords="adherence",
keywords="mobile health",
keywords="incentives",
keywords="behavioral health",
keywords="youth",
abstract="Background: Cardiovascular disease (CVD) is a leading cause of mortality and morbidity in the United States, with risk factors such as hypertension and elevated low-density lipoprotein (LDL) cholesterol originating in childhood. While statins and blood pressure--lowering medications can mitigate these risks, adherence is often poor, particularly among youth. Innovative solutions, such as monetary incentives via smartphone apps, may enhance adherence, but evidence in youth is lacking. Objective: This study aims to evaluate the efficacy of a smartphone app (Wellth) offering financial incentives to improve adherence to statins and blood pressure--lowering medications among youth aged 12 to 19 years at risk for cardiovascular disease. Methods: We initially designed a randomized controlled trial to compare the efficacy of 2 different incentive structures in youth treated with a statin for familial hypercholesterolemia with inadequate adherence. After facing recruitment challenges, the study protocol was changed to evaluating a single incentive in a pre-post design. The primary outcome was the change in adherence rate over the 60-day incentive period compared to the adherence rate during the 14-day run-in period. The secondary outcome was a change in LDL cholesterol level. Adjustments to the protocol were made in response to recruitment challenges during the COVID-19 pandemic, simplifying the incentive structure and expanding eligibility criteria. Results: The study is currently undergoing recruitment and collection of data from the first participants. The study has faced recruitment challenges exacerbated by the COVID-19 pandemic, necessitating protocol modifications. Detailed analysis of adherence rates and LDL cholesterol changes is ongoing. Conclusions: This study explores the efficacy of monetary incentives delivered through a smartphone app to improve medication adherence in youth at risk for CVD. The findings will be used to build upon the existing literature in an effort to improve medication adherence throughout the life course and ultimately reduce CVD. Trial Registration: ClinicalTrials.gov NCT04458766; https://clinicaltrials.gov/study/NCT04458766 International Registered Report Identifier (IRRID): DERR1-10.2196/65105 ",
doi="10.2196/65105",
url="https://www.researchprotocols.org/2025/1/e65105"
}


@Article{info:doi/10.2196/73711,
author="Brown, S. Chelsea
and Dziewietin, Luna
and Partridge, Virginia
and Myers, Rae Jennifer",
title="Developing an Equitable Machine Learning--Based Music Intervention for Older Adults At Risk for Alzheimer Disease: Protocol for Algorithm Development and Validation",
journal="JMIR Res Protoc",
year="2025",
month="Aug",
day="7",
volume="14",
pages="e73711",
keywords="Alzheimer disease",
keywords="digital health",
keywords="lifestyle",
keywords="machine learning",
keywords="music",
abstract="Background: Given the high prevalence and cost of Alzheimer disease (AD), it is crucial to develop equitable interventions to address lifestyle factors associated with AD incidence (eg, depression). While lifestyle interventions show promise for reducing cognitive decline, culturally sensitive interventions are needed to ensure acceptability and engagement. Given the increased risk for AD and health care barriers among rural-residing older adults, tailoring interventions to align with rural culture and distinct needs is important to improve accessibility and adherence. Objective: This protocol aims to develop an intelligent recommendation system capable of identifying the optimal therapeutic music components to elicit engagement and resonate with diverse rural-residing older adults at risk for AD. Aim 1 is to develop culturally inclusive user personas for rural-residing older adults to understand their goals and challenges for music-based digital health intervention. Aim 2 is to develop knowledge embedding--based machine learning (ML) models that use music metadata and survey response data to identify optimal therapeutic music components for enhancing engagement and emotional resonance for depression among rural-residing older adults at risk for AD. Aim 3 is to assess acceptability for personalized therapeutic music sessions and ML-based music recommendations with a separate sample. Methods: Participants (N=1200) will be aged 55 years or older and residing in the United States. In phase 1, participants (n=1000) will receive 5 randomized songs and complete a survey to understand the sentiment, cultural relevance, and perceived benefit for each song. Brief, researcher-created Likert surveys will be used. In phase 2, survey data will be used to develop ML algorithms in collaboration with the University of Massachusetts Amherst Center for Data Science and Artificial Intelligence. These ML models will be integrated into the digital music intervention and tested with a separate sample of 200 participants. Similar to phase 1, participants will be provided with sets of songs generated by the recommendation system based on the target goal (ie, to reduce depression). The recommendation accuracy of the ML algorithm will be assessed using multiple performance metrics, including root-mean-square error and normalized discounted cumulative gain as well as the mean acceptability score with a goal of 85\% user acceptability. Results: Participant recruitment is complete for phases 1 and 2 as of June 2025. Data analysis for the results of aims 1, 2, and 3 are underway and results are expected to be published in the fall of 2025. Conclusions: This protocol seeks to use ML to improve the equitability and accessibility of a digital lifestyle intervention for AD. International Registered Report Identifier (IRRID): DERR1-10.2196/73711 ",
doi="10.2196/73711",
url="https://www.researchprotocols.org/2025/1/e73711"
}


@Article{info:doi/10.2196/65659,
author="Chappell, Delaney Kaitlyn
and Fox, Melissa
and Armstrong, Scott Thomas
and Ajibulu, Lekan
and Seow, H. Cynthia
and Montano-Loza, Aldo
and Kroeker, I. Karen
and Kaplan, G. Gilaad
and Novak, Kerri
and Ma, Christopher
and Ingram, Richard
and Hoentjen, Frank
and Halloran, Brendan
and Peerani, Farhad
and Kao, Dina
and Wong, Karen",
title="Developing and Evaluating a Bundled Digital Tool to Improve Complex Care and Self-Management of Patients With Inflammatory Bowel Disease: Protocol for a Hybrid Effectiveness-Implementation Study",
journal="JMIR Res Protoc",
year="2025",
month="Aug",
day="1",
volume="14",
pages="e65659",
keywords="digital health",
keywords="self-management",
keywords="electronic medical records",
keywords="quality of life",
keywords="diet",
keywords="mental health",
keywords="inflammatory bowel disease",
keywords="social determinants of health",
keywords="implementation",
abstract="Background: Individuals with inflammatory bowel disease (IBD) require comprehensive care to address the physical and psychosocial burden of their disease. The demand for IBD care often exceeds availability, resulting in delayed access and suboptimal management. As a result, patients with IBD are required to self-manage significant aspects of their disease between appointments with their medical team. Digital self-management tools may help address this gap by empowering patients to be more engaged in managing their disease, potentially improving outcomes and reducing the strain on the health care system. Objective: This study aimed to design, implement, and evaluate a bundled digital health tool, MyIBDToolkit, with the overarching goal of improving the quality of care and self-management for patients with IBD in Alberta, Canada. Methods: A bundled digital health tool, MyIBDToolkit, will be integrated into our provincial electronic health record system to ensure broad accessibility and continuity of care. We will use a type 2 hybrid effectiveness-implementation design to evaluate both the clinical impact and real-world integration of the toolkit. We will assess effectiveness through changes in key outcomes such as health care utilization (eg, emergency visits, hospitalizations), disease burden on patients (eg, quality of life, symptom control), and burden on the health care system. These outcomes will be measured using comprehensive health care administrative data. A dual-comparison approach will be used: a within-subject comparison of health care utilization and disease burden before and after implementation of the MyIBDToolkit, and a between-group comparison of outcomes among toolkit users versus nonusers. To evaluate implementation success, we will examine reach (ie, number of patients and providers using the tool), fidelity to the planned timeline, sustained use over time, and factors influencing adoption and maintenance. Our goal is to reach 10,000 patients across Alberta, Canada, within three years. Results: We received funding for this project in January 2023. In preparation for the pilot launch, we have identified key stakeholders, including patients, health care providers and, administrators, and developed strategies to assess their readiness for MyIBDToolkit. We are also collecting mixed-methods data from patients to explore potential barriers and facilitators to using MyIBDToolkit. The first phase of MyIBDToolkit was launched in October 2024. Conclusions: MyIBDToolkit represents a scalable and patient-centered approach to the self-management of IBD care. By empowering patients to self-manage their disease between health care visits, we aim to reduce the burden of IBD on patients, providers, and the health care system. By evaluating the effectiveness and the implementation of the MyIBDToolkit, we aim to generate actionable and sustainable improvements to IBD care in Alberta. International Registered Report Identifier (IRRID): PRR1-10.2196/65659 ",
doi="10.2196/65659",
url="https://www.researchprotocols.org/2025/1/e65659"
}


@Article{info:doi/10.2196/70303,
author="Plummer, Chris
and Cong, Cen
and Milne-Ives, Madison
and Threlfall, Lynsey
and Roux, Le Peta
and Meinert, Edward",
title="Improving the Predictive Accuracy of the National Early Warning Score 2: Protocol for Algorithm Refinement",
journal="JMIR Res Protoc",
year="2025",
month="Jul",
day="21",
volume="14",
pages="e70303",
keywords="clinical deterioration",
keywords="National Early Warning Score",
keywords="performance",
keywords="proof-of-concept",
abstract="Background: The National Early Warning Score 2 (NEWS2) has been widely adopted for predicting patient deterioration in health care settings using routinely collected physiological observations. The use of NEWS2 has been shown to reduce in-hospital mortality, but it has limited accuracy in the prediction of clinically important outcomes, especially over longer time periods. Objective: This project aims to improve the predictive accuracy of the NEWS2 scoring system, particularly its accuracy over more than 24 hours and its predictive value in older patients and children. It will investigate whether using the currently collected data differently and the inclusion of additional data would result in an improved algorithm. Methods: The study will use historical patient data from the Newcastle upon Tyne Hospitals NHS Foundation Trust, including observational data (eg, vital signs), BMI- related data, and other outcome-related variables (eg, mortality rates) to train and test an algorithm to predict the risk of key clinical outcomes, including mortality, intensive therapy unit admission, sepsis, and cardiac arrest, to demonstrate a proof of concept for a modified scoring system. The algorithm's performance will be assessed based on its accuracy, precision, F1-score, area under the curve, and receiver operating characteristic curve. Results: The study is expected to start in April 2025. The findings are expected to be produced by the end of 2026 and will be disseminated at symposia, conferences, and in journal publications. Conclusions: The refined NEWS2 algorithm will address limited accuracy in predicting clinical deterioration beyond 24 hours in the original system by incorporating additional variables. Improved accuracy in the early detection of deterioration can lead to timely interventions, potentially reducing mortality and adverse clinical events. The enhanced algorithm also has the potential to be integrated into existing clinical decision support systems to facilitate health care professionals' decision-making. International Registered Report Identifier (IRRID): PRR1-10.2196/70303 ",
doi="10.2196/70303",
url="https://www.researchprotocols.org/2025/1/e70303"
}


@Article{info:doi/10.2196/67014,
author="Cowart, Kevin
and White, T. Raechel
and Olson, Kevin
and Carris, W. Nicholas
and Hanna, Karim
and Zgibor, Janice",
title="Impact of Pharmacist-Led Continuous Glucose Monitoring on Clinical Outcomes in People With Type 2 Diabetes in Primary Care: Protocol for a Prospective Cohort Study",
journal="JMIR Res Protoc",
year="2025",
month="May",
day="23",
volume="14",
pages="e67014",
keywords="type 2 diabetes",
keywords="continuous glucose monitoring",
keywords="pharmacist",
keywords="primary care",
keywords="family medicine",
keywords="prospective study",
abstract="Background: Continuous glucose monitoring (CGM) is increasingly being recognized as the new standard of care for glycemic monitoring in people with type 2 diabetes (T2D). However, despite advances in therapeutics and technology, glycemic control remains suboptimal. Team-based approaches involving pharmacists, particularly in primary care, have shown to be effective in addressing these shortcomings yet have not been rigorously evaluated in the literature. Objective: Herein we present the protocol for a study that seeks to evaluate the change in hemoglobin A1c (HbA1c) in people with T2D using CGM under a pharmacist-led approach as compared with a pharmacist-led approach using no CGM (only self-monitoring blood glucose with a glucometer). We will also assess changes in CGM-derived glycemic outcomes, health behavior, and safety outcomes among the pharmacist-led CGM cohort. Methods: This is a 12-week prospective cohort study in an academic family medicine department. We will enroll adults with T2D and a HbA1c level of ?8\%. Participants in the intervention cohort will wear a CGM sensor (FreeStyle Libre 2) for 12 weeks and receive structured diabetes self-management education and support from a pharmacist. Each participant in the intervention group will have 5 visits with a pharmacist. The primary objective is the between-group difference in change in HbA1c levels from baseline to 12 weeks between the intervention and historical cohort. Secondary objectives include a change in CGM-derived metrics among the intervention group from baseline to 12 weeks, and a change in health behavior via the Summary of Diabetes Self-Care Activities measure from baseline to 12 weeks in the intervention cohort. A CGM survey will also be administered to participants in the intervention cohort to evaluate changes in diet, physical activity, general lifestyle, and medication adherence. Safety endpoints will also be evaluated. The primary and secondary outcomes will be analyzed within and between groups using descriptive statistics, with a multivariable regression analysis conducted as appropriate to adjust for potential known confounding effects. Results: This study was funded in July 2023. We began enrolling participants in December 2024. At the time of writing, 3 participants have been enrolled. It is anticipated that we will conclude this study in December 2025 and expect to disseminate results in March 2026. Conclusions: Results of this study will further elucidate the role of pharmacist-led CGM in primary care. Trial Registration: ClinicalTrials.gov NCT06572306; https://clinicaltrials.gov/study/NCT06572306 International Registered Report Identifier (IRRID): PRR1-10.2196/67014 ",
doi="10.2196/67014",
url="https://www.researchprotocols.org/2025/1/e67014"
}


@Article{info:doi/10.2196/69541,
author="Arsalandeh, Farshad
and Shahbazi, Ali
and Nazari, Ali Mohammad",
title="Exploring the Link Between Visual Attention to Familiar or Novel Food Stimuli and Food Choice Using Integrated Electroencephalography and Eye Tracking: Protocol for Nonrandomized Pilot Study",
journal="JMIR Res Protoc",
year="2025",
month="May",
day="21",
volume="14",
pages="e69541",
keywords="attentional bias",
keywords="eye tracking",
keywords="stimuli familiarity",
keywords="dot-probe",
keywords="electroencephalography",
abstract="Background: Understanding the factors influencing food choice is critical for developing effective strategies to promote healthier eating habits and creating policies that support public health. Attentional bias, the inclination to focus attention on specific stimuli, plays a significant role in shaping food preferences by affecting how individuals perceive and react to various food-related elements. Various methodologies exist to examine attentional bias, including the dot-probe task, which measures reaction times to probes appearing after paired stimuli (eg, novel vs familiar food images); eye-tracking, which tracks gaze patterns and fixations to determine visual attention; and electroencephalography, which records brain activity, capturing early and late neural responses (eg, N100, P300) linked to attention processing; however, integrated approaches combining these methods to assess bias toward familiar versus novel foods remain underexplored. Objective: This study aims to examine differences in attention toward familiar versus novel food stimuli using integrated eye-tracking, dot-probe, and electroencephalography methods, and to explore associations with self-reported food choice. Methods: A total of 40 healthy adult participants will be recruited. Participants will be presented with pairs of familiar or novel food images, while their visual attention and brain activity are recorded concurrently. Eye-tracking metrics, including time to first fixation and total fixation duration, will be used to assess visual attention. Electroencephalography data will be collected to measure the amplitude of event-related potential components, such as P300 and N100, associated with attentional processing. Reaction times will also be recorded as a behavioral measure of attentional engagement with familiar versus novel food items. Data analysis will involve repeated measures ANOVA to examine the effects of food familiarity and novelty on attentional bias metrics. Correlation analyses will also be conducted to explore the relationships between eye-tracking, electroencephalography, and dot-probe measures. Results: This study was approved by the Ethics Committee of the Iran University of Medical Sciences in February 2021 and funded in January 2022. Data collection began in November 2022 and is expected to be completed in July 2025. As of the submission of this study, 36 individuals have been recruited. Data analysis has not yet commenced, but it is planned to begin upon the completion of data collection. The results are anticipated to be published by December 2025. The protocol was registered with the Open Science Framework in September 2024. Conclusions: The main outcome of this study is identifying differences in attentional bias metrics toward familiar versus novel food stimuli at different presentation times. These findings will provide preliminary data on the application of an integrated approach for capturing attentional bias to food-based stimuli based on their familiarity or novelty, and how these biases may be linked to food choice behaviors. International Registered Report Identifier (IRRID): DERR1-10.2196/69541 ",
doi="10.2196/69541",
url="https://www.researchprotocols.org/2025/1/e69541"
}


@Article{info:doi/10.2196/63483,
author="Decataldo, Alessandra
and Paleardi, Federico
and Lauritano, Giacomo
and Figlino, Francesca Maria
and Russo, Concetta
and Novello, Mino
and Fiore, Brunella
and Ciuffo, Giulia
and Ionio, Chiara",
title="Preventing Premature Family Maladjustment: Protocol for a Multidisciplinary eHealth Study on Preterm Parents' Well-Being",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="18",
volume="14",
pages="e63483",
keywords="preterm birth",
keywords="parental well-being",
keywords="sociology of health",
keywords="digital-based monitoring",
keywords="mixed methods research",
keywords="eHealth",
abstract="Background: The consequences of preterm birth extend beyond the clinical conditions of the newborn, profoundly impacting the functioning and well-being of families. Parents of preterm infants often describe the experience of preterm birth and subsequent admission to the neonatal intensive care unit (NICU) as a disruptive event in their lives, triggering feelings of guilt, helplessness, and fear. Although various research examines changes in parents' well-being and perception of self-efficacy during the stay in the NICU, there is a lack of research analyzing what happens in the transition phase at home after the baby's discharge. Recently, scholars have advocated for the use of web-based support programs to monitor and prevent preterm family maladjustment and assist parents. Objective: This interdisciplinary research will develop a sociopsychological model focused on assessing the well-being of parents of premature infants during and after their stay in a NICU. Specifically, the study aims to (1) monitor the mental health of parents of premature infants both at the time of the child's discharge from the NICU and in the first 6 months after discharge to prevent family maladjustment, (2) deepen our understanding of the role of digital tools in monitoring and supporting preterm parents' well-being, and (3) study the potential impact of the relationship with health care professionals on the overall well-being of parents. Methods: This project combines mixed methods of social research and psychological support with an eHealth approach. The well-being of parents of premature infants will be assessed using validated scales administered through a questionnaire to parents of preterm infants within 6 NICUs at the time of the child's discharge. Subsequently, a follow-up assessment of parental well-being will be implemented through the administration of the validated scales in a web application. In addition, an ethnographic phase will be conducted in the NICUs involving observation of the interaction between health care professionals and parents as well as narrative interviews with health care staff. Finally, interactions within the digital environment of the web application will be analyzed using a netnographic approach. We expect to shed light on the determinants of well-being among parents of premature infants in relation to varying levels of prematurity severity; sociodemographic characteristics such as gender, age, and socioeconomic status; and parental involvement in NICU care practices. With the follow-up phase via web application, this project also aims to prevent family maladjustment by providing psychological support and using an eHealth tool. Results: The results are expected by October 2025, the expiration date of the Project of Relevant National Interest. Conclusions: The eHealth Study on Preterm Parents' Well-Being aims to improve preterm parents' well-being and, indirectly, children's health by reducing social costs. Furthermore, it promotes standardized neonatal care protocols, reducing regional disparities and strengthening collaboration between parents and health care staff. International Registered Report Identifier (IRRID): PRR1-10.2196/63483 ",
doi="10.2196/63483",
url="https://www.researchprotocols.org/2025/1/e63483"
}


@Article{info:doi/10.2196/63099,
author="Tremblay, Dominique
and Joly-Mischlich, Thomas
and Dufour, Annick
and Battista, Marie-Claude
and Berbiche, Djamal
and C{\^o}t{\'e}, Jos{\'e}
and D{\'e}celles, Marco
and Forget, Catherine
and Gu{\'e}rin, Brigitte
and Larivi{\`e}re, Manon
and Lemay, Fr{\'e}d{\'e}ric
and Lemonde, Manon
and Maillet, {\'E}ric
and Moreau, Nathalie
and Pavic, Michel
and Soldera, Sara
and Wilhelmy, Catherine",
title="Telehomecare Monitoring for Patients Receiving Anticancer Oral Therapy: Protocol for a Mixed Methods Evaluability Study",
journal="JMIR Res Protoc",
year="2025",
month="Jan",
day="20",
volume="14",
pages="e63099",
keywords="telehealth",
keywords="virtual care",
keywords="telehomecare monitoring",
keywords="anticancer oral therapy",
keywords="oncology",
keywords="electronic patient-reported outcomes",
keywords="electronic patient-reported experience",
keywords="evaluability study",
keywords="mixed methods",
keywords="implementation.",
abstract="Background: Telehomecare monitoring (TM) in patients with cancer is a complex intervention. Research shows variations in the benefits and challenges TM brings to equitable access to care, the therapeutic relationship, self-management, and practice transformation. Further investigation into these variations factors will improve implementation processes and produce effective outcomes. Objective: This study aims to concurrently analyze implementation and evaluate the effectiveness of TM for patients receiving anticancer oral therapy. The objectives are to (1) contextualize how and why TM is implemented according to (a) site characteristics, (b) team characteristics, and (c) characteristics of patients receiving anticancer oral therapy; (2) assess TM effectiveness for recording electronic patient-reported outcome measures (ePROMs) and patient-reported experience measures (ePREMs) according to the site, implementation process, and patient characteristics; (3) describe the acceptability and feasibility of TM from the perspectives of the people directly or indirectly involved and provide evidence-based actionable guidance in anticipation of provincewide implementation. Methods: This type II hybrid effectiveness-implementation study uses a concurrent mixed methods design. Evaluability assessment is integrated into an emerging practice in 3 participating sites to enable the evaluation of implementation strategies on TM clinical outcomes. Quantitative data for ePROMs and ePREMs will be collected using validated oncology questionnaire. Descriptive statistics and repeated measures using multiple linear mixed models and generalized estimating equations analyses will be undertaken alongside interpretive descriptive coding of qualitative data. Qualitative data will be gathered from key informants guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework and its extension, PRISM (practical robust implementation and sustainability model). The concurrent approach allows results at multiple stages of this study to be integrated iteratively. The methodological choice aims to provide real-world data that are rigorous, rapidly usable in practice, and transferable to other settings. Results: Questionnaires were pretested and the technological platform was codeveloped with members of the cancer care team and patients. Preparatory work was carried out to configure the TM platform and activate coordinating mechanisms between members of the cancer care team, patients, information technology experts, and the research team. A steering committee with 3 working groups was established to oversee the technological, clinical, and evaluation aspects of this study. Recruitment of patients for ePROMs started in February 2024, and data collection is expected to continue until March 2025. Interviews with members of the cancer care team began in November 2024. Full analysis should be completed by September 2025. Conclusions: This study will clarify how, why, for whom, and under what conditions TM can complement current care models. Our evaluability assessment will help to address implementation complexities and better understand intervention-to-practice operationalization so that implementation might be adapted to contextual factors without potentially harmful or inequitable impacts on patients. International Registered Report Identifier (IRRID): DERR1-10.2196/63099 ",
doi="10.2196/63099",
url="https://www.researchprotocols.org/2025/1/e63099"
}


@Article{info:doi/10.2196/54046,
author="Miller, M. Janis
and Wyman, F. Jean
and An, Lawrence
and Chu, Haitao
and Fok, S. Cynthia
and Lavender, Missy
and Lewis, Elizabeth Cora
and Markland, D. Alayne
and Rickey, M. Leslie
and Sheng, Ying
and Sutcliffe, Siobhan
and Low, Kane Lisa
and Mueller, R. Elizabeth
and ",
title="Design of a Tool Capable of Assessing Environmental Sociocultural Physical Factors Influencing Women's Decisions on When and Where to Toilet Within Real-World Settings: Protocol for the Build and Usability Testing of a Mobile App for Use by Community-Dwelling Women",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="18",
volume="13",
pages="e54046",
keywords="mobile app",
keywords="urinary bladder",
keywords="woman's health",
keywords="toileting",
keywords="ecological momentary assessment",
keywords="time factors",
keywords="population studies",
keywords="real-world environment",
keywords="mobile phone",
abstract="Background: Although surveys and apps are available for women to report urination and bladder symptoms, they do not include their decisions regarding toileting. Real-world factors can interfere with toileting decisions, which may then influence bladder health. This premise lacks data per want of a robust data collection tool. Objective: The Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium engaged a transdisciplinary team to build and test WhereIGo, a mobile data collection app for Android and iOS. The design goal was a comprehensive reporting system for capturing environmental, sociocultural, and physical factors that influence women's decisions for toileting. Aims include having (1) an innovative feature for reporting physiologic urge sensation when ``thinking about my bladder'' and shortly before ``I just peed,'' (2) real-time reporting along with short look-back opportunities, and (3) ease of use anywhere. Methods: The development team included a plain language specialist, a usability specialist, creative designers, programming experts, and PLUS scientific content experts. Both real-time and ecological momentary assessments were used to comprehensively capture influences on toileting decisions including perceived access to toileting, degree of busyness or stress or focus, beverage intake amount, urge degree, or a leakage event. The restriction on the maximal number of taps for any screen was six. PLUS consortium investigators did pilot-testing. Formal usability testing relied on the recruitment of community-dwelling women at four PLUS research sites. Women used the app for 2 consecutive days. Outcome measures were the system usability scale (SUS; 0-100 range) and the functional Mobile Application Rating Scale (1-5 range). These scales were embedded at the end of the app. The estimated a priori sample size needed, considering the SUS cut point score set at ?74, was 40 women completing the study. Results: Funding was provided by the National Institute of Diabetes and Digestive and Kidney Diseases since July 2015. The integrity of the build process was documented through multiple 5-minute videos presented to PLUS Consortium and through WhereIGo screenshots of the final product. Participants included 44 women, with 41 (93\%) completing data collection. Participants ranged in age from 21 to 85 years, were predominantly non-Hispanic White (n=25, 57\%), college-educated (n=25, 57\%), and with incomes below US \$75,000 (n=27, 62\%). The SUS score was 78.0 (SE 1.7), which was higher than 75\% of the 500 products tested by the SUS developers. The mean functional Mobile Application Rating Scale score was 4.4 (SE 0.08). The build and informal acceptability testing were completed in 2019, enrollment for formal usability testing completed by June 2020, and analysis was completed in 2022. Conclusions: WhereIGo is a novel app with good usability for women to report toileting decisions, urination, and fluid intake. Future research using the app could test the influence of real-time factors on bladder health. International Registered Report Identifier (IRRID): RR1-10.2196/54046 ",
doi="10.2196/54046",
url="https://www.researchprotocols.org/2024/1/e54046"
}


@Article{info:doi/10.2196/64332,
author="Hogue, Aaron
and Bobek, Molly
and Porter, P. Nicole
and MacLean, Alexandra
and Henderson, E. Craig
and Jensen-Doss, Amanda
and Diamond, M. Gary
and Southam-Gerow, A. Michael
and Ehrenreich-May, Jill",
title="Family Support Protocol for Adolescent Internalizing Disorders: Protocol for a Pre-Post Quantitative Treatment Development Study",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="16",
volume="13",
pages="e64332",
keywords="adolescent substance use",
keywords="adolescent anxiety and depression",
keywords="cooccurring disorders",
keywords="adjunctive treatment",
keywords="family-based interventions",
keywords="usual care",
abstract="Background: Internalizing disorders (IDs), primarily depression and anxiety, are highly prevalent among adolescents receiving community-based treatment for substance use disorders (SUDs). For such clients, interventions that do not holistically address both SUDs and IDs are less effective. Objective: This pilot treatment development study aims to develop and test a modular treatment protocol for addressing cooccurring IDs among adolescents (aged 13 to 18 years) enrolled in routine care for substance use problems: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by 3 evidence-based foundations for treating cooccurring adolescent IDs: family engagement techniques, transdiagnostic individual cognitive behavioral therapy techniques, and family psychoeducation and safety planning. Methods: This quasi-experimental study will proceed in 2 stages. The pilot stage will use rapid-cycle prototyping methods in collaboration with end-user stakeholders to draft protocol delivery and fidelity guidelines adapted from existing resources, solicit provider and client input on protocol content and delivery via cognitive interviewing, and pilot prototype components on 4 to 6 cases. The second stage will be an interrupted time series study for 60 comorbid SUD+ID cases across 2 sites serving diverse adolescents: 30 will receive treatment as usual (TAU); following clinician training in the protocol, 30 new cases will receive TAU enhanced by Fam-AID. For aim 1, the focus is on evaluating the acceptability of the Fam-AID protocol through therapist and client interviews as well as assessing fidelity benchmarks using therapist- and observer-reported protocol fidelity data. For aim 2, the plan is to compare the effects of TAU only cases versus TAU+Fam-AID cases on family treatment attendance and on adolescent ID and substance use symptoms, with measurements taken at baseline and at 3-month and 6-month follow-ups. Results: Study recruitment will begin in April 2025. Conclusions: We anticipate that Fam-AID will contain 5 treatment modules that can be delivered in any sequence to meet client needs: family engagement of primary supports in treatment planning and services; relational reframing of family constraints, resiliencies, and social capital connected to the adolescent's ID symptoms; functional analysis of the adolescent's ID symptoms and related behaviors; cognitive behavioral therapy to address the adolescent's ID symptoms and functional needs, featuring 3 core techniques (emotion acceptance, emotional exposure, and behavioral activation) to address negative affect and emotional dysregulation; and family psychoeducation and safety planning focused on education about comorbid SUD+ID and prevention of adolescent self-harm. If the abovementioned modules are found to be feasible and effective, Fam-AID will offer a set of pragmatic interventions to SUD clinicians for treating cooccurring IDs in adolescent clients. Trial Registration: ClinicalTrials.gov NCT06413979; https://www.clinicaltrials.gov/study/NCT06413979 International Registered Report Identifier (IRRID): PRR1-10.2196/64332 ",
doi="10.2196/64332",
url="https://www.researchprotocols.org/2024/1/e64332"
}


@Article{info:doi/10.2196/60099,
author="Garc{\'i}a-Sangen{\'i}s, Ana
and Modena, Daniela
and Jensen, Nygaard Jette
and Chalkidou, Athina
and Antsupova, S. Valeria
and Marloth, Tina
and Theut, Marie Anna
and Gonz{\'a}lez L{\'o}pez-Valc{\'a}rcel, Beatriz
and Raynal, Fabiana
and Vallejo-Torres, Laura
and Lykkegaard, Jesper
and Hansen, Plejdrup Malene
and S{\o}ndergaard, Jens
and Olsen, Kanstrup Jonas
and Munck, Anders
and Balint, Andr{\'a}s
and Benko, Ria
and Petek, Davorina
and Sodja, Nina
and Kowalczyk, Anna
and Godycki-Cwirko, Maciej
and Glasov{\'a}, Helena
and Glasa, Jozef
and Radzeviciene Jurgute, Ruta
and Jaruseviciene, Lina
and Lionis, Christos
and Anastasaki, Marilena
and Angelaki, Agapi
and Petelos, Elena
and Alvarez, Laura
and Ricart, Marta
and Briones, Sergi
and Ruppe, Georg
and Monf{\`a}, Ramon
and Bjerrum, Anders
and Llor, Carl",
title="Improving Antibiotic Use in Nursing Homes by Infection Prevention and Control and Antibiotic Stewardship (IMAGINE): Protocol for a Before-and-After Intervention and Implementation Study",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="16",
volume="13",
pages="e60099",
keywords="antimicrobial stewardship",
keywords="medical audit",
keywords="hygiene",
keywords="antibacterial agents",
keywords="quality improvement",
keywords="nursing homes",
keywords="health personnel",
keywords="drug resistance, microbial",
keywords="frail elderly",
abstract="Background: Despite the extensive use of antibiotics and the growing challenge of antimicrobial resistance, there has been a lack of substantial initiatives aimed at diminishing the prevalence of infections in nursing homes and enhancing the detection of urinary tract infections (UTIs). Objective: This study aims to systematize and enhance efforts to prevent health care--associated infections, mainly UTIs and reduce antibiotic inappropriateness by implementing a multifaceted intervention targeting health care professionals in nursing homes. Methods: A before-and-after intervention study carried out in a minimum of 10 nursing homes in each of the 8 European participating countries (Denmark, Greece, Hungary, Lithuania, Poland, Slovakia, Slovenia, and Spain). A team of 4 professionals consisting of nurses, doctors, health care assistants, or health care helpers are actively involved in each nursing home. Over the initial 3-month period, professionals in each nursing home are registering information on UTIs as well as infection and prevention control measures by means of the Audit Project Odense method. The audit will be repeated after implementing a multifaceted intervention. The intervention will consist of feedback and discussion of the results from the first registration, training on the implementation of infection and prevention control techniques provided by experts, appropriateness of the diagnostic approach and antibiotic prescribing for UTIs, and provision of information materials on infection control and antimicrobial stewardship targeted to staff, residents, and relatives. We will compare the pre- and postintervention audit results using chi-square test for prescription appropriateness and Student t test for implemented hygiene elements. Results: A total of 109 nursing homes have participated in the pilot study and the first registration audit. The results of the first audit registration are expected to be published in autumn of 2024. The final results will be published by the end of 2025. Conclusions: This is a European Union--funded project aimed at contributing to the battle against antimicrobial resistance through improvement of the quality of management of common infections based on evidence-based interventions tailored to the nursing home setting and a diverse range of professionals. We expect the intervention to result in a significant increase in the number of hygiene activities implemented by health care providers and residents. Additionally, we anticipate a marked reduction in the number of inappropriately managed UTIs, as well as a substantial decrease in the overall incidence of infections following the intervention. International Registered Report Identifier (IRRID): DERR1-10.2196/60099 ",
doi="10.2196/60099",
url="https://www.researchprotocols.org/2024/1/e60099",
url="http://www.ncbi.nlm.nih.gov/pubmed/39284176"
}


@Article{info:doi/10.2196/57663,
author="Barnes, Keely
and Sveistrup, Heidi
and Bayley, Mark
and Rathbone, Michel
and Taljaard, Monica
and Egan, Mary
and Bilodeau, Martin
and Karimijashni, Motahareh
and Marshall, Shawn",
title="Reliability and Sensitivity of a Virtual Assessment Developed for Workplace Concussions: Protocol for a Method-Comparison Study",
journal="JMIR Res Protoc",
year="2024",
month="Jul",
day="26",
volume="13",
pages="e57663",
keywords="telehealth",
keywords="virtual care",
keywords="concussion",
keywords="mTBI",
keywords="mild traumatic brain injury",
keywords="assessment",
keywords="examination",
abstract="Background: Workplace mild traumatic brain injuries are frequently associated with persistent symptoms, leading to a reduction in productivity at work or even disability. People who sustain workplace injuries frequently need rehabilitation and support, and the challenges of delivering these services was heightened during the COVID-19 pandemic as injured workers had to be cared for remotely. Currently, clinicians are conducting both in-person and virtual (remote) concussion assessments; however, the measures that are being used to complete these assessments have undocumented psychometric properties. Objective: This study will document the psychometric properties of the clinical measures that are being used remotely and their ability to produce similar results to in-person assessments. Specifically, through this method-comparison study, we aim to (1) evaluate the sensitivity of the measures included in a virtual assessment toolkit when compared to an in-person assessment and (2) determine the interrater and intrarater reliabilities of the measures included in a virtual assessment toolkit. Methods: Patient participants (people living with acquired brain injuries) will attend two assessments (in person and virtual) at the Ottawa Hospital. The two assessments will be identical, consisting of the measures included in our previously developed virtual concussion assessment toolkit, which includes finger-to-nose testing, the Vestibular/Ocular Motor Screening tool, balance testing, cervical spine range of motion, saccades testing, and evaluation of effort. All virtual assessments will occur using the Microsoft Teams platform and will be audio/video-recorded. The clinician assessor and patient participant will complete a feedback form following completion of the assessments. A different clinician will also document the findings on observed videos of the virtual assessment shortly after completion of both in-person and virtual assessments and approximately 1 month later. Interrater reliability will be assessed by comparing the second clinician's observation with the first clinician's initial virtual assessment. Intrarater reliability will be evaluated by comparing the second clinician's observation with their own assessment approximately 1 month later. Sensitivity will be documented by comparing the findings (identification of abnormality) of the in-person assessment completed by the initial clinician assessor with those of the second clinician assessor on the observation of the recording of the virtual assessment. Results: As of May 2024, we have recruited 7 clinician assessors and completed study assessments with 39 patient participants. The study recruitment is expected to be completed by September 2024. Conclusions: Currently, it is unknown if completing concussion assessments virtually produces similar results to the in-person assessment. This work will serve as a first step to determining the similarity of the virtual assessment to the matching in-person assessment and will provide information on the reliability of the virtual assessment. International Registered Report Identifier (IRRID): DERR1-10.2196/57663 ",
doi="10.2196/57663",
url="https://www.researchprotocols.org/2024/1/e57663"
}


@Article{info:doi/10.2196/55559,
author="Galea, T. Jerome
and Vasquez, H. Diego
and Rupani, Neil
and Gordon, B. Moya
and Tapia, Milagros
and Greene, Y. Karah
and Kolevic, Lenka
and Franke, F. Molly
and Contreras, Carmen",
title="Development and Pilot-Testing of an Optimized Conversational Agent or ``Chatbot'' for Peruvian Adolescents Living With HIV to Facilitate Mental Health Screening, Education, Self-Help, and Linkage to Care: Protocol for a Mixed Methods, Community-Engaged Study",
journal="JMIR Res Protoc",
year="2024",
month="May",
day="7",
volume="13",
pages="e55559",
keywords="chatbot",
keywords="digital assistant",
keywords="depression",
keywords="HIV",
keywords="adolescents",
abstract="Background: Adolescents living with HIV are disproportionally affected by depression, which worsens antiretroviral therapy adherence, increases viral load, and doubles the risk of mortality. Because most adolescents living with HIV live in low- and middle-income countries, few receive depression treatment due to a lack of mental health services and specialists in low-resource settings. Chatbot technology, used increasingly in health service delivery, is a promising approach for delivering low-intensity depression care to adolescents living with HIV in resource-constrained settings. Objective: The goal of this study is to develop and pilot-test for the feasibility and acceptability of a prototype, optimized conversational agent (chatbot) to provide mental health education, self-help skills, and care linkage for adolescents living with HIV. Methods: Chatbot development comprises 3 phases conducted over 2 years. In the first phase (year 1), formative research will be conducted to understand the views, opinions, and preferences of up to 48 youths aged 10-19 years (6 focus groups of up to 8 adolescents living with HIV per group), their caregivers (5 in-depth interviews), and HIV program personnel (5 in-depth interviews) regarding depression among adolescents living with HIV. We will also investigate the perceived acceptability of a mental health chatbot, including barriers and facilitators to accessing and using a chatbot for depression care by adolescents living with HIV. In the second phase (year 1), we will iteratively program a chatbot using the SmartBot360 software with successive versions (0.1, 0.2, and 0.3), meeting regularly with a Youth Advisory Board comprised of adolescents living with HIV who will guide and inform the chatbot development and content to arrive at a prototype version (version 1.0) for pilot-testing. In the third phase (year 2), we will pilot-test the prototype chatbot among 50 adolescents living with HIV na{\"i}ve to its development. Participants will interact with the chatbot for up to 2 weeks, and data will be collected on the acceptability of the chatbot-delivered depression education and self-help strategies, depression knowledge changes, and intention to seek care linkage. Results: The study was awarded in April 2022, received institutional review board approval in November 2022, received funding in December 2022, and commenced recruitment in March 2023. By the completion of study phases 1 and 2, we expect our chatbot to incorporate key needs and preferences gathered from focus groups and interviews to develop the chatbot. By the completion of study phase 3, we will have assessed the feasibility and acceptability of the prototype chatbot. Study phase 3 began in April 2024. Final results are expected by January 2025 and published thereafter. Conclusions: The study will produce a prototype mental health chatbot developed with and for adolescents living with HIV that will be ready for efficacy testing in a subsequent, larger study. International Registered Report Identifier (IRRID): DERR1-10.2196/55559 ",
doi="10.2196/55559",
url="https://www.researchprotocols.org/2024/1/e55559",
url="http://www.ncbi.nlm.nih.gov/pubmed/38713501"
}


@Article{info:doi/10.2196/50157,
author="Dorronzoro-Zubiete, Enrique
and Castro-Marrero, Jes{\'u}s
and Ropero, Jorge
and Sevillano-Ramos, Luis Jos{\'e}
and Dolores Hern{\'a}ndez, Mar{\'i}a
and Sanmartin Senta{\~n}es, Ramon
and Alegre-Martin, Jose
and Launois-Obreg{\'o}n, Patricia
and Martin-Garrido, Isabel
and Luque Budia, Asuncion
and Lacalle-Remigio, R. Juan
and B{\'e}jar Prado, Luis
and Rivera Romero, Octavio",
title="Personalized Management of Fatigue in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Long COVID Using a Smart Digital mHealth Solution: Protocol for a Participatory Design Approach",
journal="JMIR Res Protoc",
year="2024",
month="Apr",
day="12",
volume="13",
pages="e50157",
keywords="acceptability",
keywords="myalgic encephalomyelitis/chronic fatigue syndrome",
keywords="long COVID",
keywords="mHealth",
keywords="fatigue",
keywords="physical activity",
keywords="lifestyle health",
keywords="personalized self-management",
keywords="user-centered design",
abstract="Background: Fatigue is the most common symptom in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID, impacting patients' quality of life; however, there is currently a lack of evidence-based context-aware tools for fatigue self-management in these populations. Objective: This study aimed to (1) address fatigue in ME/CFS and long COVID through the development of digital mobile health solutions for self-management, (2) predict perceived fatigue severity using real-time data, and (3) assess the feasibility and potential benefits of personalized digital mobile health solutions. Methods: The MyFatigue project adopts a patient-centered approach within the participatory health informatics domain. Patient representatives will be actively involved in decision-making processes. This study combines inductive and deductive research approaches, using qualitative studies to generate new knowledge and quantitative methods to test hypotheses regarding the relationship between factors like physical activity, sleep behaviors, and perceived fatigue in ME/CFS and long COVID. Co-design methods will be used to develop a personalized digital solution for fatigue self-management based on the generated knowledge. Finally, a pilot study will evaluate the feasibility, acceptance, and potential benefits of the digital health solution. Results: The MyFatigue project opened to enrollment in November 2023. Initial results are expected to be published by the end of 2024. Conclusions: This study protocol holds the potential to expand understanding, create personalized self-management approaches, engage stakeholders, and ultimately improve the well-being of individuals with ME/CFS and long COVID. International Registered Report Identifier (IRRID): PRR1-10.2196/50157 ",
doi="10.2196/50157",
url="https://www.researchprotocols.org/2024/1/e50157",
url="http://www.ncbi.nlm.nih.gov/pubmed/38608263"
}


@Article{info:doi/10.2196/53684,
author="Cook, L. Robert
and Richards, L. Veronica
and Gullett, M. Joseph
and Lerner, G. Brenda D.
and Zhou, Zhi
and Porges, C. Eric
and Wang, Yan
and Kahler, W. Christopher
and Barnett, P. Nancy
and Li, Zhigang
and Pallikkuth, Suresh
and Thomas, Emmanuel
and Rodriguez, Allan
and Bryant, J. Kendall
and Ghare, Smita
and Barve, Shirish
and Govind, Varan
and D{\'e}vieux, G. Jessy
and Cohen, A. Ronald
and ",
title="Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial",
journal="JMIR Res Protoc",
year="2024",
month="Apr",
day="2",
volume="13",
pages="e53684",
keywords="alcohol",
keywords="contingency management",
keywords="biosensor",
keywords="HIV infection",
keywords="cognitive function",
abstract="Background: Both alcohol consumption and HIV infection are associated with worse brain, cognitive, and clinical outcomes in older adults. However, the extent to which brain and cognitive dysfunction is reversible with reduction or cessation of drinking is unknown. Objective: The 30-Day Challenge study was designed to determine whether reduction or cessation of drinking would be associated with improvements in cognition, reduction of systemic and brain inflammation, and improvement in HIV-related outcomes in adults with heavy drinking. Methods: The study design was a mechanistic experimental trial, in which all participants received an alcohol reduction intervention followed by repeated assessments of behavioral and clinical outcomes. Persons were eligible if they were 45 years of age or older, had weekly alcohol consumption of 21 or more drinks (men) or 14 or more drinks (women), and were not at high risk of alcohol withdrawal. After a baseline assessment, participants received an intervention consisting of contingency management (money for nondrinking days) for at least 30 days followed by a brief motivational interview. After this, participants could either resume drinking or not. Study questionnaires, neurocognitive assessments, neuroimaging, and blood, urine, and stool samples were collected at baseline, 30 days, 90 days, and 1 year after enrollment. Results: We enrolled 57 persons with heavy drinking who initiated the contingency management protocol (mean age 56 years, SD 4.6 years; 63\%, n=36 male, 77\%, n=44 Black, and 58\%, n=33 people with HIV) of whom 50 completed 30-day follow-up and 43 the 90-day follow-up. The planned study procedures were interrupted and modified due to the COVID-19 pandemic of 2020-2021. Conclusions: This was the first study seeking to assess changes in brain (neuroimaging) and cognition after alcohol intervention in nontreatment-seeking people with HIV together with people without HIV as controls. Study design strengths, limitations, and lessons for future study design considerations are discussed. Planned analyses are in progress, after which deidentified study data will be available for sharing. Trial Registration: ClinicalTrials.gov NCT03353701; https://clinicaltrials.gov/study/NCT03353701 International Registered Report Identifier (IRRID): DERR1-10.2196/53684 ",
doi="10.2196/53684",
url="https://www.researchprotocols.org/2024/1/e53684",
url="http://www.ncbi.nlm.nih.gov/pubmed/38564243"
}


@Article{info:doi/10.2196/52365,
author="Silva, Rui
and Morou{\c{c}}o, Pedro
and Lains, Jorge
and Amorim, Paula
and Alves, Nuno
and Veloso, Prieto Ant{\'o}nio",
title="Innovative Design and Development of Personalized Ankle-Foot Orthoses for Survivors of Stroke With Equinovarus Foot: Protocol for a Feasibility and Comparative Trial",
journal="JMIR Res Protoc",
year="2024",
month="Apr",
day="2",
volume="13",
pages="e52365",
keywords="3D printing",
keywords="3D scanner",
keywords="ankle foot orthosis",
keywords="biomechanical analysis",
keywords="equinovarus foot",
abstract="Background: Ankle-foot orthoses (AFOs) are vital in gait rehabilitation for patients with stroke. However, many conventional AFO designs may not offer the required precision for optimized patient outcomes. With the advent of 3D scanning and printing technology, there is potential for more individualized AFO solutions, aiming to enhance the rehabilitative process. Objective: This nonrandomized trial seeks to introduce and validate a novel system for AFO design tailored to patients with stroke. By leveraging the capabilities of 3D scanning and bespoke software solutions, the aim is to produce orthoses that might surpass conventional designs in terms of biomechanical effectiveness and patient satisfaction. Methods: A distinctive 3D scanner, complemented by specialized software, will be developed to accurately capture the biomechanical data of leg movements during gait in patients with stroke. The acquired data will subsequently guide the creation of patient-specific AFO designs. These personalized orthoses will be provided to participants, and their efficacy will be compared with traditional AFO models. The qualitative dimensions of this experience will be evaluated using the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) assessment tool. Feedback from health care professionals and the participants will be considered throughout the trial to ensure a rounded understanding of the system's implications. Results: Spatial-temporal parameters will be statistically compared using paired t tests to determine significant differences between walking with the personalized orthosis, the existing orthosis, and barefoot conditions. Significant differences will be identified based on P values, with P<.05 indicating statistical significance. The Statistical Parametric Mapping method will be applied to graphically compare kinematic and kinetic data across the entire gait cycle. QUEST responses will undergo statistical analysis to evaluate patient satisfaction, with scores ranging from 1 (not satisfied) to 5 (very satisfied). Satisfaction scores will be presented as mean and SD values. Significant variations in satisfaction levels between the personalized and existing orthosis will be assessed using a Wilcoxon signed rank test. The anticipation is that the AFOs crafted through this innovative system will either match or outperform existing orthoses in use, with higher patient satisfaction rates. Conclusions: Embracing the synergy of technology and biomechanics may hold the key to revolutionizing orthotic design, with the potential to set new standards in patient-centered orthotic solutions. However, as with all innovations, a balanced approach, considering both the technological possibilities and individual patient needs, will be paramount to achieving optimal outcomes. International Registered Report Identifier (IRRID): PRR1-10.2196/52365 ",
doi="10.2196/52365",
url="https://www.researchprotocols.org/2024/1/e52365",
url="http://www.ncbi.nlm.nih.gov/pubmed/38564249"
}


@Article{info:doi/10.2196/54681,
author="Castiglione, Angela Sonia
and Lavoie-Tremblay, M{\'e}lanie
and Kilpatrick, Kelley
and Gifford, Wendy
and Semenic, Elizabeth Sonia",
title="Exploring Shared Implementation Leadership of Point of Care Nursing Leadership Teams on Inpatient Hospital Units: Protocol for a Collective Case Study",
journal="JMIR Res Protoc",
year="2024",
month="Feb",
day="19",
volume="13",
pages="e54681",
keywords="case study",
keywords="evidence-based practices",
keywords="implementation leadership",
keywords="inpatient hospital units",
keywords="nursing leadership",
keywords="point of care",
abstract="Background: Nursing leadership teams at the point of care (POC), consisting of both formal and informal leaders, are regularly called upon to support the implementation of evidence-based practices (EBPs) in hospital units. However, current conceptualizations of effective leadership for successful implementation typically focus on the behaviors of individual leaders in managerial roles. Little is known about how multiple nursing leaders in formal and informal roles share implementation leadership (IL), representing an important knowledge gap. Objective: This study aims to explore shared IL among formal and informal nursing leaders in inpatient hospital units. The central research question is as follows: How is IL shared among members of POC nursing leadership teams on inpatient hospital units? The subquestions are as follows: (1) What IL behaviors are enacted and shared by formal and informal leaders? (2) What social processes enable shared IL by formal and informal leaders? and (3) What factors influence shared IL in nursing leadership teams? Methods: We will use a collective case study approach to describe and generate an in-depth understanding of shared IL in nursing. We will select nursing leadership teams on 2 inpatient hospital units that have successfully implemented an EBP as instrumental cases. We will construct data through focus groups and individual interviews with key informants (leaders, unit staff, and senior nurse leaders), review of organizational documents, and researcher-generated field notes. We have developed a conceptual framework of shared IL to guide data analysis, which describes effective IL behaviors, formal and informal nursing leaders' roles at the POC, and social processes generating shared leadership and influencing contextual factors. We will use the Framework Method to systematically generate data matrices from deductive and inductive thematic analysis of each case. We will then generate assertions about shared IL following a cross-case analysis. Results: The study protocol received research ethics approval (2022-8408) on February 24, 2022. Data collection began in June 2022, and we have recruited 2 inpatient hospital units and 25 participants. Data collection was completed in December 2023, and data analysis is ongoing. We anticipate findings to be published in a peer-reviewed journal by late 2024. Conclusions: The anticipated results will shed light on how multiple and diverse members of the POC nursing leadership team enact and share IL. This study addresses calls to advance knowledge in promoting effective implementation of EBPs to ensure high-quality health care delivery by further developing the concept of shared IL in a nursing context. We will identify strategies to strengthen shared IL in nursing leadership teams at the POC, informing future intervention studies. International Registered Report Identifier (IRRID): DERR1-10.2196/54681 ",
doi="10.2196/54681",
url="https://www.researchprotocols.org/2024/1/e54681",
url="http://www.ncbi.nlm.nih.gov/pubmed/38373024"
}


@Article{info:doi/10.2196/52799,
author="Rochon, A. Elizabeth
and Sy, Maimouna
and Phillips, Mirelle
and Anderson, Erik
and Plys, Evan
and Ritchie, Christine
and Vranceanu, Ana-Maria",
title="Bio-Experiential Technology to Support Persons With Dementia and Care Partners at Home (TEND): Protocol for an Intervention Development Study",
journal="JMIR Res Protoc",
year="2023",
month="Dec",
day="29",
volume="12",
pages="e52799",
keywords="dementia",
keywords="dyadic",
keywords="bio-experiential",
keywords="serious gaming",
keywords="psychosocial",
abstract="Background: Alzheimer disease and related dementias are debilitating and incurable diseases. Persons with dementia and their informal caregivers (ie, dyads) experience high rates of emotional distress and negative health outcomes. Several barriers prevent dyads from engaging in psychosocial care including cost, transportation, and a lack of treatments that target later stages of dementia and target the dyad together. Technologically informed treatment and serious gaming have been shown to be feasible and effective among persons living with dementia and their care partners. To increase access, there is a need for technologically informed psychosocial interventions which target the dyad, together in the home. Objective: This study aims to develop the toolkit for experiential well-being in dementia, a dyadic, ``bio-experiential'' intervention for persons with dementia and their caregivers. Per our conceptual model, the toolkit for experiential well-being in dementia platform aims to target sustained attention, positive emotions, and active engagement among dyads. In this paper, we outline the protocol and conceptual model for intervention development and partnership with design and development experts. Methods: We followed the National Institutes of Health (NIH) stage model (stage 1A) and supplemented the model with principles of user-centered design. The first step includes understanding user needs, goals, and strengths. We met this step by engaging in methodology and definition synthesis and conducting focus groups with dementia care providers (N=10) and persons with dementia and caregivers (N=11). Step 2 includes developing and refining the prototype. We will meet this step by engaging dyads in up to 20 iterations of platform $\beta$ testing workshops. Step 3 includes observing user interactions with the prototype. We will meet this step by releasing the platform for feasibility testing. Results: Key takeaways from the focus groups include balancing individualization and the dyadic relationship and avoiding confusing stimuli. As of September 2023, we have completed focus groups with providers, persons with dementia, and their caregivers. Additionally, we have conducted 4 iterations of $\beta$ testing workshops with dyads. Feedback from focus groups informed the $\beta$ testing workshops; data have not yet been formally analyzed and will be reported in future publications. Conclusions: Technological interventions, particularly ``bio-experiential'' technology, can be used in dementia care to support emotional health among persons with a diagnosis and caregivers. Here, we outline a collaborative intervention development process of bio-experiential technology through a research, design, and development partnership. Next, we are planning to test the platform's feasibility as well as its impact on clinical outcomes and mechanisms of action. International Registered Report Identifier (IRRID): DERR1-10.2196/52799 ",
doi="10.2196/52799",
url="https://www.researchprotocols.org/2023/1/e52799",
url="http://www.ncbi.nlm.nih.gov/pubmed/38157239"
}


@Article{info:doi/10.2196/52117,
author="McDermott, Katherine
and Levey, Nadine
and Brewer, Julie
and Ehmann, Madison
and Hooker, E. Julia
and Pasinski, Roger
and Yousif, Neda
and Raju, Vidya
and Gholston, Milton
and Greenberg, Jonathan
and Ritchie, S. Christine
and Vranceanu, Ana-Maria",
title="Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic",
journal="JMIR Res Protoc",
year="2023",
month="Dec",
day="29",
volume="12",
pages="e52117",
keywords="chronic pain",
keywords="mind-body",
keywords="underserved",
keywords="musculoskeletal pain",
keywords="pain",
keywords="older adults",
keywords="pain management",
keywords="feasibility",
keywords="intervention",
abstract="Background: Chronic musculoskeletal pain is prevalent and disabling among older adults in underserved communities. Psychosocial pain management is more effective than pharmacological treatment in older adults. However, underserved community clinics often lack psychosocial treatments, in part because of a lack of trained providers. Shared medical appointments, in which patients undergo brief medical evaluation, monitoring, counseling, and group support, are an efficacious and cost-effective method for chronic disease management in underserved clinics, reducing the need for specialized providers. However, shared medical visits are often ineffective for chronic pain, possibly owing to lack of inclusion of skills most relevant for older adults (eg, pacing to increase engagement in daily activities). Objective: We have described the protocol for the development and initial pilot effectiveness testing of the GetActive+ mind-body activity intervention for older adults with chronic pain. GetActive+ was adapted from GetActive, an evidence-based intervention that improved pain outcomes among mostly affluent White adults. We aim to establish the initial feasibility, acceptability, fidelity, and effectiveness of GetActive+ when delivered as part of shared medical appointments in a community clinic. Methods: We conducted qualitative focus groups and individual interviews with providers (n=25) and English-speaking older adults (aged ?55 y; n=18) with chronic pain to understand the pain experience in this population, perceptions about intervention content, and barriers to and facilitators of intervention participation and implementation in this setting. Qualitative interviews with Spanish-speaking older adults are in progress and will inform a future open pilot of the intervention in Spanish. We are currently conducting an open pilot study with exit interviews in English (n=30 individuals in total). Primary outcomes are feasibility (?75\% of patients who are approached agree to participate), acceptability (?75\% of patients who enrolled complete 8 out of 10 sessions; qualitative), and fidelity (?75\% of session components are delivered as intended). Secondary outcomes include physical function---self-reported, performance based (6-minute walk test), and objective (step count)---and emotional function (depression and anxiety). Other assessments include putative mechanisms (eg, mindfulness and pain catastrophizing). Results: We began enrolling participants for the qualitative phase in November 2022 and the open pilot phase in May 2023. We completed the qualitative phase with providers and English-speaking patients, and the results are being analyzed using a hybrid, inductive-deductive approach. We conducted rapid analysis of these data to develop GetActive+ before the open pilot in English, including increasing readability and clarity of language, reducing the number of skills taught to increase time for individual check-ins and group participation, and increasing experiential exercises for skill uptake. Conclusions: We provide a blueprint for the refinement of a mind-body activity intervention for older adults with chronic pain in underserved community clinics and for incorporation within shared medical visits. It will inform a future, fully powered, effectiveness-implementation trial of GetActive+ to help address the chronic pain epidemic among older adults. Trial Registration: ClinicalTrials.gov NCT05782231; https://clinicaltrials.gov/study/NCT05782231 International Registered Report Identifier (IRRID): DERR1-10.2196/52117 ",
doi="10.2196/52117",
url="https://www.researchprotocols.org/2023/1/e52117",
url="http://www.ncbi.nlm.nih.gov/pubmed/38157234"
}


@Article{info:doi/10.2196/53556,
author="Minian, Nadia
and Mehra, Kamna
and Earle, Mackenzie
and Hafuth, Sowsan
and Ting-A-Kee, Ryan
and Rose, Jonathan
and Veldhuizen, Scott
and Zawertailo, Laurie
and Ratto, Matt
and Melamed, C. Osnat
and Selby, Peter",
title="AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study",
journal="JMIR Res Protoc",
year="2023",
month="Dec",
day="11",
volume="12",
pages="e53556",
keywords="evaluation",
keywords="health bot",
keywords="medication adherence",
keywords="smoking cessation",
keywords="varenicline",
keywords="artificial intelligence",
keywords="AI",
abstract="Background: Varenicline is a pharmacological intervention for tobacco dependence that is safe and effective in facilitating smoking cessation. Enhanced adherence to varenicline augments the probability of prolonged smoking abstinence. However, research has shown that one-third of people who use varenicline are nonadherent by the second week. There is evidence showing that behavioral support helps with medication adherence. We have designed an artificial intelligence (AI) conversational agent or health bot, called ``ChatV,'' based on evidence of what works as well as what varenicline is, that can provide these supports. ChatV is an evidence-based, patient- and health care provider--informed health bot to improve adherence to varenicline. ChatV has been programmed to provide medication reminders, answer questions about varenicline and smoking cessation, and track medication intake and the number of cigarettes. Objective: This study aims to explore the feasibility of the ChatV health bot, to examine if it is used as intended, and to determine the appropriateness of proceeding with a randomized controlled trial. Methods: We will conduct a mixed methods feasibility study where we will pilot-test ChatV with 40 participants. Participants will be provided with a standard 12-week varenicline regimen and access to ChatV. Passive data collection will include adoption measures (how often participants use the chatbot, what features they used, when did they use it, etc). In addition, participants will complete questionnaires (at 1, 4, 8, and 12 weeks) assessing self-reported smoking status and varenicline adherence, as well as questions regarding the acceptability, appropriateness, and usability of the chatbot, and participate in an interview assessing acceptability, appropriateness, fidelity, and adoption. We will use ``stop, amend, and go'' progression criteria for pilot studies to decide if a randomized controlled trial is a reasonable next step and what modifications are required. A health equity lens will be adopted during participant recruitment and data analysis to understand and address the differences in uptake and use of this digital health solution among diverse sociodemographic groups. The taxonomy of implementation outcomes will be used to assess feasibility, that is, acceptability, appropriateness, fidelity, adoption, and usability. In addition, medication adherence and smoking cessation will be measured to assess the preliminary treatment effect. Interview data will be analyzed using the framework analysis method. Results: Participant enrollment for the study will begin in January 2024. Conclusions: By using predetermined progression criteria, the results of this preliminary study will inform the determination of whether to advance toward a larger randomized controlled trial to test the effectiveness of the health bot. Additionally, this study will explore the acceptability, appropriateness, fidelity, adoption, and usability of the health bot. These insights will be instrumental in refining the intervention and the health bot. Trial Registration: ClinicalTrials.gov NCT05997901; https://classic.clinicaltrials.gov/ct2/show/NCT05997901 International Registered Report Identifier (IRRID): PRR1-10.2196/53556 ",
doi="10.2196/53556",
url="https://www.researchprotocols.org/2023/1/e53556",
url="http://www.ncbi.nlm.nih.gov/pubmed/38079201"
}


@Article{info:doi/10.2196/53874,
author="Wooldridge, S. Jennalee
and Morse, L. Jessica
and Delgado, Jorge
and Afari, Niloofar",
title="Daily Functioning of Veterans With Type 2 Diabetes: Protocol for an Ambulatory Assessment Study",
journal="JMIR Res Protoc",
year="2023",
month="Nov",
day="20",
volume="12",
pages="e53874",
keywords="type 2 diabetes mellitus",
keywords="ecological momentary assessment",
keywords="ambulatory assessment",
keywords="intensive longitudinal assessment",
keywords="physical activity",
keywords="self-management  behavior",
keywords="functioning",
keywords="social support",
abstract="Background: Diabetes impacts nearly 25\% of veterans. Many veterans do not engage in recommended physical activity and other diabetes self-management behaviors. Type 2 diabetes is generally asymptomatic; as such, the long-term consequences of inadequate self-management and benefits of consistent self-management are not salient in the short term. Furthermore, self-management behaviors typically take place outside of medical visits; however, self-management--related factors are only assessed during medical visits, likely missing large amounts of variability. Thus, ambulatory assessment methods such as ecological momentary assessment (EMA), accelerometry, and continuous glucose monitoring are needed to understand the dynamics of daily self-management and identify potential intervention targets. Objective: The overarching goal of this study is to understand daily, time-varying factors (comorbid affective symptoms and social context) that influence physical activity, diabetes self-management, glycemic management, daily functioning, and quality of life in participants' natural environments. Methods: We are recruiting veterans with type 2 diabetes (target N=100). Participants are required to complete a battery of baseline assessments related to mental health, psychosocial factors, and self-management behaviors. Participants then receive 5 momentary EMA surveys and 1 daily EMA survey per day, in which veterans report comorbid affective symptoms (mood, stress, and pain), social support, social interactions, physical activity, and other self-management behaviors. Momentary surveys are delivered randomly during daily preprogrammed intervals over a 14-day sampling period. Accelerometry and continuous glucose monitoring are also used to assess physical activity and blood glucose, respectively. The first 6 participants also completed interviews assessing their experience in the study and barriers to participation. These test participants informed modifications to the protocol for the remaining participants. Results: The project received funding in April of 2023. Enrollment began in March of 2023 and is planned to be completed in April 2025. Among the 6 test participants, the overall EMA response rate was 87\% (range 74\%-95\%). The response rate for the EMA survey including daily items (67\%, range 21\%-93\%) was lower than the earlier shorter EMA surveys (89\%, range 81\%-96\%). The mean rate of valid accelerometer wear of at least 20 hours per day was 93\% (SD 11\%), and continuous glucose monitoring data were available for 91\% (SD 17\%) of days on average. Participants reported few barriers to completing EMA surveys but noted the random timing of questions made it difficult to plan around, and the end-of-day survey was long. Two participants reported survey items reminded or motivated them to engage in diabetes self-management behaviors. Conclusions: Assessment tools developed from this study can inform clinical decision-making by considering barriers to self-management that occur in daily life. Clinical applications include tailored, adaptive technology--supported interventions to improve self-management that provide the right type and amount of support at the right time by adapting to an individual's changing internal and contextual state. International Registered Report Identifier (IRRID): DERR1-10.2196/53874 ",
doi="10.2196/53874",
url="https://www.researchprotocols.org/2023/1/e53874",
url="http://www.ncbi.nlm.nih.gov/pubmed/37983070"
}


@Article{info:doi/10.2196/46847,
author="Ming, Y. David
and Wong, Willis
and Jones, A. Kelley
and Antonelli, C. Richard
and Gujral, Nitin
and Gonzales, Sarah
and Rogers, Ursula
and Ratliff, William
and Shah, Nirmish
and King, A. Heather",
title="Feasibility of Implementation of a Mobile Digital Personal Health Record to Coordinate Care for Children and Youth With Special Health Care Needs in Primary Care: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="20",
volume="12",
pages="e46847",
keywords="digital health",
keywords="personal health record",
keywords="children with special health care needs",
keywords="care coordination",
keywords="mixed methods",
keywords="mobile phone",
abstract="Background: Electronic health record (EHR)--integrated digital personal health records (PHRs) via Fast Healthcare Interoperability Resources (FHIR) are promising digital health tools to support care coordination (CC) for children and youth with special health care needs but remain widely unadopted; as their adoption grows, mixed methods and implementation research could guide real-world implementation and evaluation. Objective: This study (1) evaluates the feasibility of an FHIR-enabled digital PHR app for CC for children and youth with special health care needs, (2) characterizes determinants of implementation, and (3) explores associations between adoption and patient- or family-reported outcomes. Methods: This nonrandomized, single-arm, prospective feasibility trial will test an FHIR-enabled digital PHR app's use among families of children and youth with special health care needs in primary care settings. Key app features are FHIR-enabled access to structured data from the child's medical record, families' abilities to longitudinally track patient- or family-centered care goals, and sharing progress toward care goals with the child's primary care provider via a clinician dashboard. We shall enroll 40 parents or caregivers of children and youth with special health care needs to use the app for 6 months. Inclusion criteria for children and youth with special health care needs are age 0-16 years; primary care at a participating site; complex needs benefiting from CC; high hospitalization risk in the next 6 months; English speaking; having requisite technology at home (internet access, Apple iOS mobile device); and an active web-based EHR patient portal account to which a parent or caregiver has full proxy access. Digital prescriptions will be used to disseminate study recruitment materials directly to eligible participants via their existing EHR patient portal accounts. We will apply an intervention mixed methods design to link quantitative and qualitative (semistructured interviews and family engagement panels with parents of children and youth with special health care needs) data and characterize implementation determinants. Two CC frameworks (Pediatric Care Coordination Framework; Patient-Centered Medical Home) and 2 evaluation frameworks (Consolidated Framework for Implementation Research; Technology Acceptance Model) provide theoretical foundations for this study. Results: Participant recruitment began in fall 2022, before which we identified >300 potentially eligible patients in EHR data. A family engagement panel in fall 2021 generated formative feedback from family partners. Integrated analysis of pretrial quantitative and qualitative data informed family-centered enhancements to study procedures. Conclusions: Our findings will inform how to integrate an FHIR-enabled digital PHR app for children and youth with special health care needs into clinical care. Mixed methods and implementation research will help strengthen implementation in diverse clinical settings. The study is positioned to advance knowledge of how to use digital health innovations for improving care and outcomes for children and youth with special health care needs and their families. Trial Registration: ClinicalTrials.gov NCT05513235; https://clinicaltrials.gov/study/NCT05513235 International Registered Report Identifier (IRRID): DERR1-10.2196/46847 ",
doi="10.2196/46847",
url="https://www.researchprotocols.org/2023/1/e46847",
url="http://www.ncbi.nlm.nih.gov/pubmed/37728977"
}


@Article{info:doi/10.2196/45532,
author="Bannon, Sarah
and Brewer, Julie
and Ahmad, Nina
and Cornelius, Talea
and Jackson, Jonathan
and Parker, A. Robert
and Dams-O'Connor, Kristen
and Dickerson, C. Bradford
and Ritchie, Christine
and Vranceanu, Ana-Maria",
title="A Live Video Dyadic Resiliency Intervention to Prevent Chronic Emotional Distress Early After Dementia Diagnoses: Protocol for a Dyadic Mixed Methods Study",
journal="JMIR Res Protoc",
year="2023",
month="Sep",
day="20",
volume="12",
pages="e45532",
keywords="dyad",
keywords="dementia",
keywords="emotional distress",
keywords="intervention",
keywords="diagnosis",
keywords="telehealth",
abstract="Background: By 2030, approximately 75 million adults will be living with Alzheimer disease and related dementias (ADRDs). ADRDs produce cognitive, emotional, and behavioral changes for persons living with dementia that undermine independence and produce considerable stressors for persons living with dementia and their spousal care-partners---together called a ``dyad.'' Clinically elevated emotional distress (ie, depression and anxiety symptoms) is common for both dyad members after ADRD diagnosis, which can become chronic and negatively impact relationship functioning, health, quality of life, and collaborative management of progressive symptoms. Objective: This study is part of a larger study that aims to develop, adapt, and establish the feasibility of Resilient Together for Alzheimer Disease and Related Dementias (RT-ADRD), a novel dyadic skills-based intervention aimed at preventing chronic emotional distress. This study aims to gather comprehensive information to develop the first iteration of RT-ADRD and inform a subsequent open pilot. Here, we describe the proposed study design and procedures. Methods: All procedures will be conducted virtually (via phone and Zoom) to minimize participant burden and gather information regarding feasibility and best practices surrounding virtual procedures for older adults. We will recruit dyads (up to n=20) from Mount Sinai Hospital (MSH) clinics within 1 month of ADRD diagnosis. Dyads will be self-referred or referred by their treating neurologists and complete screening to assess emotional distress and capacity to consent to participate in the study. Consenting dyads will then participate in a 60-minute qualitative interview using an interview guide designed to assess common challenges, unmet needs, and support preferences and to gather feedback on the proposed RT-ADRD intervention content and design. Each dyad member will then have the opportunity to participate in an optional individual interview to gather additional feedback. Finally, each dyad member will complete a brief quantitative survey remotely (by phone, tablet, or computer) via a secure platform to assess feasibility of assessment and gather preliminary data to explore associations between proposed mechanisms of change and secondary outcomes. We will conduct preliminary explorations of feasibility markers, including recruitment, screening, live video interviews, quantitative data collection, and mixed methods analyses. Results: This study has been approved by the MSH Institutional Review Board. We anticipate that the study will be completed by late 2023. Conclusions: We will use results from this study to develop the first live video telehealth dyadic resiliency intervention focused on the prevention of chronic emotional distress in couples shortly after ADRD diagnoses. Our study will allow us to gather comprehensive information from dyads on important factors to address in an early prevention-focused intervention and to explore feasibility of study procedures to inform future open pilot and pilot feasibility randomized control trial investigations of RT-ADRD. International Registered Report Identifier (IRRID): PRR1-10.2196/45532 ",
doi="10.2196/45532",
url="https://www.researchprotocols.org/2023/1/e45532",
url="http://www.ncbi.nlm.nih.gov/pubmed/37728979"
}


@Article{info:doi/10.2196/48128,
author="Hekman, J. Daniel
and Cochran, L. Amy
and Maru, P. Apoorva
and Barton, J. Hanna
and Shah, N. Manish
and Wiegmann, Douglas
and Smith, A. Maureen
and Liao, Frank
and Patterson, W. Brian",
title="Effectiveness of an Emergency Department--Based Machine Learning Clinical Decision Support Tool to Prevent Outpatient Falls Among Older Adults: Protocol for a Quasi-Experimental Study",
journal="JMIR Res Protoc",
year="2023",
month="Aug",
day="3",
volume="12",
pages="e48128",
keywords="falls",
keywords="emergency medicine",
keywords="machine learning",
keywords="clinical decision support",
keywords="automated screening",
keywords="geriatrics",
abstract="Background: Emergency department (ED) providers are important collaborators in preventing falls for older adults because they are often the first health care providers to see a patient after a fall and because at-home falls are often preceded by previous ED visits. Previous work has shown that ED referrals to falls interventions can reduce the risk of an at-home fall by 38\%. Screening patients at risk for a fall can be time-consuming and difficult to implement in the ED setting. Machine learning (ML) and clinical decision support (CDS) offer the potential of automating the screening process. However, it remains unclear whether automation of screening and referrals can reduce the risk of future falls among older patients. Objective: The goal of this paper is to describe a research protocol for evaluating the effectiveness of an automated screening and referral intervention. These findings will inform ongoing discussions about the use of ML and artificial intelligence to augment medical decision-making. Methods: To assess the effectiveness of our program for patients receiving the falls risk intervention, our primary analysis will be to obtain referral completion rates at 3 different EDs. We will use a quasi-experimental design known as a sharp regression discontinuity with regard to intent-to-treat, since the intervention is administered to patients whose risk score falls above a threshold. A conditional logistic regression model will be built to describe 6-month fall risk at each site as a function of the intervention, patient demographics, and risk score. The odds ratio of a return visit for a fall and the 95\% CI will be estimated by comparing those identified as high risk by the ML-based CDS (ML-CDS) and those who were not but had a similar risk profile. Results: The ML-CDS tool under study has been implemented at 2 of the 3 EDs in our study. As of April 2023, a total of 1326 patient encounters have been flagged for providers, and 339 unique patients have been referred to the mobility and falls clinic. To date, 15\% (45/339) of patients have scheduled an appointment with the clinic. Conclusions: This study seeks to quantify the impact of an ML-CDS intervention on patient behavior and outcomes. Our end-to-end data set allows for a more meaningful analysis of patient outcomes than other studies focused on interim outcomes, and our multisite implementation plan will demonstrate applicability to a broad population and the possibility to adapt the intervention to other EDs and achieve similar results. Our statistical methodology, regression discontinuity design, allows for causal inference from observational data and a staggered implementation strategy allows for the identification of secular trends that could affect causal associations and allow mitigation as necessary. Trial Registration: ClinicalTrials.gov NCT05810064; https://www.clinicaltrials.gov/study/NCT05810064 International Registered Report Identifier (IRRID): DERR1-10.2196/48128 ",
doi="10.2196/48128",
url="https://www.researchprotocols.org/2023/1/e48128",
url="http://www.ncbi.nlm.nih.gov/pubmed/37535416"
}


@Article{info:doi/10.2196/38282,
author="Guo, Joyce
and Blyth, Phil
and Clifford, Kari
and Hooper, Nikki
and Crawford, Haemish",
title="Transfer Validity of Pediatric Supracondylar Humeral Fracture Pin Placement Practice on In-Theater Performance by Orthopedic Trainees Using an Augmented Reality Simulator: Protocol for a Pilot Interventional Cohort Study With a Retrospective Comparator Cohort",
journal="JMIR Res Protoc",
year="2023",
month="Aug",
day="2",
volume="12",
pages="e38282",
keywords="pediatric orthopedics",
keywords="augmented reality simulator",
keywords="supracondylar humeral fractures",
keywords="closed reduction and percutaneous pinning",
keywords="transfer validity",
keywords="fracture",
keywords="surgeons",
keywords="education",
keywords="practice",
keywords="trainees",
keywords="pediatric",
keywords="orthopedic",
keywords="training",
keywords="surgical procedure",
abstract="Background: Supracondylar humeral fractures (SCHF) are a common cause of orthopedic morbidity in pediatric populations across the world. The treatment of this fracture is likely one of the first procedures involving x-ray--guided wire insertion that trainee orthopedic surgeons will encounter in their career. Traditional surgical training methods of ``see one, do one, teach one'' are reliant on the presence of real-world cases and must be conducted within an operative environment. We have developed an augmented reality simulator that allows trainees to practice this procedure in a radiation-free environment at no extra risk to patients. Objective: This study aims to examine whether training on a simulator in addition to traditional surgical training improves the in-theater performance of trainees. Methods: This multicenter, interventional cohort study will involve orthopedic trainees from New Zealand in their first year of advanced training between 2019 and 2023. Advanced trainees with no simulator exposure who were in their first year in 2019-2021 will form the comparator cohort, while those in the years 2022-2023 will receive additional regular simulator training as the intervention cohort. The comparator cohort's performance in pediatric SCHF surgery will be retrospectively audited using routinely collected operative outcomes and parameters over a 6-month period. Data on the performance of the intervention cohorts will be collected in the same way over a comparable period. The data collected for both groups will be used to determine whether additional training with an augmented reality training shows improved real-world surgical outcomes compared to traditional surgical training. Results: As of February 2022, a total of 8 retrospective comparator trainees have been recruited by email. The study is financially supported through an external grant from the Wishbone Orthopaedic Research Foundation of New Zealand (September 2021) and an internal research grant from the University of Otago (July 2021). Conclusions: This protocol has been approved by the University of Otago Health Ethics committee (reference HD21/087), and the study is due for completion in 2024. This protocol may assist other researchers conducting similar studies in the field. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000816651; https://tinyurl.com/mtdkecwb International Registered Report Identifier (IRRID): DERR1-10.2196/38282 ",
doi="10.2196/38282",
url="https://www.researchprotocols.org/2023/1/e38282",
url="http://www.ncbi.nlm.nih.gov/pubmed/37531159"
}


@Article{info:doi/10.2196/47636,
author="Bramoweth, D. Adam
and Hough, E. Caroline
and McQuillan, D. Amanda
and Spitznogle, L. Brittany
and Thorpe, T. Carolyn
and Lickel, J. James
and Boudreaux-Kelly, Monique
and Hamm, E. Megan
and Germain, Anne",
title="Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial",
journal="JMIR Res Protoc",
year="2023",
month="Jul",
day="20",
volume="12",
pages="e47636",
keywords="insomnia",
keywords="sedatives and hypnotics",
keywords="mHealth",
keywords="deprescribing",
keywords="cognitive behavioral therapy",
keywords="clinical pharmacist",
keywords="veterans",
abstract="Background: Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods. Objective: The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)--led deprescribing of sedative-hypnotic medications. Methods: In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans' acceptability and usability of the COAST platform, and (3) measure changes in veterans' sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up. Results: The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use. Conclusions: Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes. Trial Registration: ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438 International Registered Report Identifier (IRRID): DERR1-10.2196/47636 ",
doi="10.2196/47636",
url="https://www.researchprotocols.org/2023/1/e47636",
url="http://www.ncbi.nlm.nih.gov/pubmed/37471122"
}


@Article{info:doi/10.2196/46464,
author="Barzilay, Shira
and Fine, Shai
and Akhavan, Shannel
and Haruvi-Catalan, Liat
and Apter, Alan
and Brunstein-Klomek, Anat
and Carmi, Lior
and Zohar, Mishael
and Kinarty, Inbar
and Friedman, Talia
and Fennig, Silvana",
title="Real-Time Real-World Digital Monitoring of Adolescent Suicide Risk During the Six Months Following Emergency Department Discharge: Protocol for an Intensive Longitudinal Study",
journal="JMIR Res Protoc",
year="2023",
month="Jun",
day="26",
volume="12",
pages="e46464",
keywords="suicide",
keywords="suicide ideation",
keywords="suicide prevention",
keywords="adolescents",
keywords="real-time assessment",
keywords="digital phenotyping",
keywords="risk assessment",
keywords="mobile phone",
abstract="Background: Suicide is the second leading cause of death in adolescents, and self-harm is one of the strongest predictors of death by suicide. The rates of adolescents presenting to emergency departments (EDs) for suicidal thoughts and behaviors (STBs) have increased. Still, existing follow-up after ED discharge is inadequate, leaving a high-risk period for reattempts and suicide. There is a need for innovative evaluation of imminent suicide risk factors in these patients, focusing on continuous real-time evaluations with low assessment burden and minimal reliance on patient disclosure of suicidal intent. Objective: This study examines prospective longitudinal associations between observed real-time mobile passive sensing, including communication and activity patterns, and clinical and self-reported assessments of STB over 6 months. Methods: This study will include 90 adolescents recruited on their first outpatient clinic visit following their discharge from the ED due to a recent STB. Participants will complete brief weekly assessments and be monitored continuously for their mobile app usage, including mobility, activity, and communication patterns, over 6 months using the iFeel research app. Participants will complete 4 in-person visits for clinical assessment at baseline and at the 1-, 3-, and 6-month follow-ups. The digital data will be processed, involving feature extraction, scaling, selection, and dimensionality reduction. Passive monitoring data will be analyzed using both classical machine learning models and deep learning models to identify proximal associations between real-time observed communication, activity patterns, and STB. The data will be split into a training and validation data set, and predictions will be matched against the clinical evaluations and self-reported STB events (ie, labels). To use both labeled and unlabeled digital data (ie, passively collected), we will use semisupervised methods in conjunction with a novel method that is based on anomaly detection notions. Results: Participant recruitment and follow-up started in February 2021 and are expected to be completed by 2024. We expect to find prospective proximal associations between mobile sensor communication, activity data, and STB outcomes. We will test predictive models for suicidal behaviors among high-risk adolescents. Conclusions: Developing digital markers of STB in a real-world sample of high-risk adolescents presenting to ED can inform different interventions and provide an objective means to assess the risk of suicidal behaviors. The results of this study will be the first step toward large-scale validation that may lead to suicide risk measures that aid psychiatric follow-up, decision-making, and targeted treatments. This novel assessment could facilitate timely identification and intervention to save young people's lives. International Registered Report Identifier (IRRID): DERR1-10.2196/46464 ",
doi="10.2196/46464",
url="https://www.researchprotocols.org/2023/1/e46464",
url="http://www.ncbi.nlm.nih.gov/pubmed/37358906"
}


@Article{info:doi/10.2196/46244,
author="Kiekens, Glenn
and Claes, Laurence
and Schoefs, Steffie
and Kemme, F. Nian D.
and Luyckx, Koen
and Kleiman, M. Evan
and Nock, K. Matthew
and Myin-Germeys, Inez",
title="The Detection of Acute Risk of Self-injury Project: Protocol for an Ecological Momentary Assessment Study Among Individuals Seeking Treatment",
journal="JMIR Res Protoc",
year="2023",
month="Jun",
day="15",
volume="12",
pages="e46244",
keywords="nonsuicidal self-injury",
keywords="suicidal thoughts and behaviors",
keywords="real-time",
keywords="experience sampling",
keywords="ecological momentary assessment",
keywords="digital interventions",
keywords="mobile phone",
abstract="Background: Nonsuicidal self-injury (NSSI) is a major mental health concern. Despite increased research efforts on establishing the prevalence and correlates of the presence and severity of NSSI, we still lack basic knowledge of the course, predictors, and relationship of NSSI with other self-damaging behaviors in daily life. Such information will be helpful for better informing mental health professionals and allocating treatment resources. The DAILY (Detection of Acute rIsk of seLf-injurY) project will address these gaps among individuals seeking treatment. Objective: This protocol paper presents the DAILY project's aims, design, and materials used. The primary objectives are to advance understanding of (1) the short-term course and contexts of elevated risk for NSSI thoughts, urges, and behavior; (2) the transition from NSSI thoughts and urges to NSSI behavior; and (3) the association of NSSI with disordered eating, substance use, and suicidal thoughts and behaviors. A secondary aim is to evaluate the perspectives of individuals seeking treatment and mental health professionals regarding the feasibility, scope, and utility of digital self-monitoring and interventions that target NSSI in daily life. Methods: The DAILY project is funded by the Research Foundation Flanders (Belgium). Data collection involves 3 phases: a baseline assessment (phase 1), 28 days of ecological momentary assessment (EMA) followed by a clinical session and feedback survey (phase 2), and 2 follow-up surveys and an optional interview (phase 3). The EMA protocol consists of regular EMA surveys (6 times per day), additional burst EMA surveys spaced at a higher frequency when experiencing intense NSSI urges (3 surveys within 30 minutes), and event registrations of NSSI behavior. The primary outcomes are NSSI thoughts, NSSI urges, self-efficacy to resist NSSI, and NSSI behavior, with disordered eating (restrictive eating, binge eating, and purging), substance use (binge drinking and smoking cannabis), and suicidal thoughts and behaviors surveyed as secondary outcomes. The assessed predictors include emotions, cognitions, contextual information, and social appraisals. Results: We will recruit approximately 120 individuals seeking treatment aged 15 to 39 years from mental health services across the Flanders region of Belgium. Recruitment began in June 2021 and data collection is anticipated to conclude in August 2023. Conclusions: The findings of the DAILY project will provide a detailed characterization of the short-term course and patterns of risk for NSSI and advance understanding of how, why, and when NSSI and other self-damaging behaviors unfold among individuals seeking treatment. This will inform clinical practice and provide the scientific building blocks for novel intervention approaches outside of the therapy room that support people who self-injure in real time. International Registered Report Identifier (IRRID): DERR1-10.2196/46244 ",
doi="10.2196/46244",
url="https://www.researchprotocols.org/2023/1/e46244",
url="http://www.ncbi.nlm.nih.gov/pubmed/37318839"
}


@Article{info:doi/10.2196/45104,
author="Rethorst, D. Chad
and Githinji, Phrashiah
and Seguin-Fowler, A. Rebecca
and MacMillan Uribe, L. Alexandra
and Szeszulski, Jacob
and Liao, Yue",
title="Real-time Assessment of the Bidirectional Relationship Between Affective States and Glucose: Protocol for a 14-Day Observational Study",
journal="JMIR Res Protoc",
year="2023",
month="Mar",
day="22",
volume="12",
pages="e45104",
keywords="affect",
keywords="glucose",
keywords="eating behavior",
keywords="glucose variability",
keywords="glucose excursion",
keywords="ecological momentary assessment",
keywords="continuous glucose monitoring",
keywords="continuous glucose monitor",
abstract="Background: Glucose variability increases cardiometabolic disease risk. While many factors can influence glucose levels, postprandial glucose response is the primary driver of glucose variability. Furthermore, affect may directly and indirectly impact glucose variability through its effect on eating behavior. Continuous glucose monitors (CGMs) facilitate the real-time evaluation of blood glucose, and ecological momentary assessment (EMA) can be used to assess affect in real time. Together, data collected from these sources provide the opportunity to further understand the role of affect in glucose levels. Objective: This paper presents the protocol for a study that aims to (1) evaluate the feasibility and acceptability of using CGMs along with EMA in nondiabetic populations and (2) examine the bidirectional relationship between affect and glucose in nondiabetic adults with overweight or obesity using a CGM and EMA. Methods: Eligibility criteria for the study include participants (1) aged 18 to 65 years old, (2) with a BMI of ?25 kg/m2, (3) who are able to read and write in English, and (4) who own a smartphone. Individuals will be excluded if they (1) have type 1 or 2 diabetes or have any other condition that requires glucose monitoring, (2) are pregnant, (3) use any medications that have the potential to alter blood glucose levels or interfere with the glucose sensing process, or (4) have a diagnosed gastrointestinal condition or eating disorder. In a 14-day observational study, participants will wear a FreeStyle Libre Pro CGM sensor (Abbott) and will receive mobile phone--based EMA prompts 6 times per day (randomly within six 2-hour windows between 8 AM and 8 PM) to assess positive and negative affect. Participants will also wear a Fitbit Inspire 2 (Fitbit) to continuously monitor physical activity and sleep, which will be included as covariates in the analysis. Multilevel linear regression models will be used to evaluate the acute relationship between glucose level and affect. Results: Recruitment started in October 2022 and is expected to be completed in March 2023. We will aim to recruit 100 participants. As of December 12, 2022, a total of 39 participants have been enrolled. Conclusions: The results of this study will further elucidate the role of affect in glucose variability. By identifying affective states that may lead to glucose excursions, our findings could inform just-in-time behavioral interventions by indicating opportunities for intervention delivery. International Registered Report Identifier (IRRID): DERR1-10.2196/45104 ",
doi="10.2196/45104",
url="https://www.researchprotocols.org/2023/1/e45104",
url="http://www.ncbi.nlm.nih.gov/pubmed/36947140"
}


@Article{info:doi/10.2196/44650,
author="Hadjidimitriou, Stelios
and Pagourelias, Efstathios
and Apostolidis, Georgios
and Dimaridis, Ioannis
and Charisis, Vasileios
and Bakogiannis, Constantinos
and Hadjileontiadis, Leontios
and Vassilikos, Vassilios",
title="Clinical Validation of an Artificial Intelligence--Based Tool for Automatic Estimation of Left Ventricular Ejection Fraction and Strain in Echocardiography: Protocol for a Two-Phase Prospective Cohort Study",
journal="JMIR Res Protoc",
year="2023",
month="Mar",
day="13",
volume="12",
pages="e44650",
keywords="artificial intelligence",
keywords="clinical validation",
keywords="computer-aided diagnosis",
keywords="echocardiography",
keywords="ejection fraction",
keywords="global longitudinal strain",
keywords="left ventricle",
keywords="prospective cohort design",
keywords="ultrasound",
abstract="Background: Echocardiography (ECHO) is a type of ultrasonographic procedure for examining the cardiac function and morphology, with functional parameters of the left ventricle (LV), such as the ejection fraction (EF) and global longitudinal strain (GLS), being important indicators. Estimation of LV-EF and LV-GLS is performed either manually or semiautomatically by cardiologists and requires a nonnegligible amount of time, while estimation accuracy depends on scan quality and the clinician's experience in ECHO, leading to considerable measurement variability. Objective: The aim of this study is to externally validate the clinical performance of a trained artificial intelligence (AI)--based tool that automatically estimates LV-EF and LV-GLS from transthoracic ECHO scans and to produce preliminary evidence regarding its utility. Methods: This is a prospective cohort study conducted in 2 phases. ECHO scans will be collected from 120 participants referred for ECHO examination based on routine clinical practice in the Hippokration General Hospital, Thessaloniki, Greece. During the first phase, 60 scans will be processed by 15 cardiologists of different experience levels and the AI-based tool to determine whether the latter is noninferior in LV-EF and LV-GLS estimation accuracy (primary outcomes) compared to cardiologists. Secondary outcomes include the time required for estimation and Bland-Altman plots and intraclass correlation coefficients to assess measurement reliability for both the AI and cardiologists. In the second phase, the rest of the scans will be examined by the same cardiologists with and without the AI-based tool to primarily evaluate whether the combination of the cardiologist and the tool is superior in terms of correctness of LV function diagnosis (normal or abnormal) to the cardiologist's routine examination practice, accounting for the cardiologist's level of ECHO experience. Secondary outcomes include time to diagnosis and the system usability scale score. Reference LV-EF and LV-GLS measurements and LV function diagnoses will be provided by a panel of 3 expert cardiologists. Results: Recruitment started in September 2022, and data collection is ongoing. The results of the first phase are expected to be available by summer 2023, while the study will conclude in May 2024, with the end of the second phase. Conclusions: This study will provide external evidence regarding the clinical performance and utility of the AI-based tool based on prospectively collected ECHO scans in the routine clinical setting, thus reflecting real-world clinical scenarios. The study protocol may be useful to investigators conducting similar research. International Registered Report Identifier (IRRID): DERR1-10.2196/44650 ",
doi="10.2196/44650",
url="https://www.researchprotocols.org/2023/1/e44650",
url="http://www.ncbi.nlm.nih.gov/pubmed/36912875"
}


@Article{info:doi/10.2196/43627,
author="Escobar-Viera, C{\'e}sar
and Coulter, S. Robert W.
and Friedman, Reuel M.
and Thoma, Brian
and Switzer, E. Galen
and Martina, Jamie
and Egan, Erin James
and Primack, Brian",
title="The Influence of Social Media Interactions and Behaviors on Depressive Symptoms Among Sexual and Gender Minority Young Adults in the United States: Protocol for a Mixed Methods Longitudinal Study",
journal="JMIR Res Protoc",
year="2023",
month="Jan",
day="24",
volume="12",
pages="e43627",
keywords="mixed methods",
keywords="longitudinal",
keywords="depression",
keywords="sexual and gender minorities",
keywords="social media",
abstract="Background: Sexual and gender minority (SGM; ie, lesbian, gay, bisexual, transgender, and otherwise queer) young adults experience disparities in depression and other internalizing psychopathology. Although social media use is widespread and SGM people have more social media accounts and are more socially active on them than non-SGM individuals, few studies have examined the impact of social media on depression in this group. Objective: The PRIDE iM study will be the first longitudinal, mixed methods research conducted to determine the impact of social media interactions and behaviors as pathways to depressive symptoms among SGM young adults living in the United States. Methods: PRIDE iM uses a bookends variation of the longitudinal sequential mixed methods design. Participants will be recruited nationally from social media. First, between July 2019 and February 2020, we conducted a qualitative phase (T1) comprising web-based individual interviews (N=58) to inform the building and content of the quantitative survey. Second, from February 2022 to September 2022, we will conduct a series of web-based surveys (N=1000 at baseline) with 4 data points (T2-T5), each one collected every 6 to 8 weeks. Third, from October 2022 to December 2022, we will conduct a second qualitative phase (T6) of web-based interviews using outcome trajectories found in the longitudinal survey analyses to purposively sample survey participants and conduct web-based interviews to contextualize and explain survey findings. Qualitative data from T1 and T6 will be analyzed using a reflexive thematic analysis approach. As we sought to capture change over time in the association between the main predictors (ie, social media interactions and behaviors) and depressive symptoms, we propose analyzing T2 to T5 data using latent growth models with a structural equation modeling framework. Data integration at the method, interpretation, and reporting levels will be achieved through building and connecting and the use of a staged approach and joint displays, respectively. At all stages, we will assess the fit of data integration as recommended by the principles of best practice for mixed methods research in psychology. Results: Data collection will be completed by December 2022. Qualitative data analyses will be completed by March 2023, and quantitative analyses of the primary outcome of interest will be completed by June 2023. Conclusions: PRIDE iM will confirm, reject, or uncover the presence of potential relationships between social media interactions and behaviors and depressive symptoms among SGM people. This study represents fundamental groundwork to develop social media--based interventions that target modifiable interactions and behaviors that are most likely to influence mental health outcomes, thus seizing the opportunity to merge the popularity of this medium among SGM people with evidence-based approaches. International Registered Report Identifier (IRRID): DERR1-10.2196/43627 ",
doi="10.2196/43627",
url="https://www.researchprotocols.org/2023/1/e43627",
url="http://www.ncbi.nlm.nih.gov/pubmed/36692929"
}


@Article{info:doi/10.2196/42653,
author="Richardson, Safiya
and Dauber-Decker, Katherine
and Solomon, Jeffrey
and Khan, Sundas
and Barnaby, Douglas
and Chelico, John
and Qiu, Michael
and Liu, Yan
and Mann, Devin
and Pekmezaris, Renee
and McGinn, Thomas
and Diefenbach, Michael",
title="Nudging Health Care Providers' Adoption of Clinical Decision Support: Protocol for the User-Centered Development of a Behavioral Economics--Inspired Electronic Health Record Tool",
journal="JMIR Res Protoc",
year="2023",
month="Jan",
day="18",
volume="12",
pages="e42653",
keywords="health informatics",
keywords="clinical decision support",
keywords="electronic health record",
keywords="implementation science",
keywords="behavioral economics",
keywords="user-centered design",
keywords="pulmonary embolism",
abstract="Background: The improvements in care resulting from clinical decision support (CDS) have been significantly limited by consistently low health care provider adoption. Health care provider attitudes toward CDS, specifically psychological and behavioral barriers, are not typically addressed during any stage of CDS development, although they represent an important barrier to adoption. Emerging evidence has shown the surprising power of using insights from the field of behavioral economics to address psychological and behavioral barriers. Nudges are formal applications of behavioral economics, defined as positive reinforcement and indirect suggestions that have a nonforced effect on decision-making. Objective: Our goal is to employ a user-centered design process to develop a CDS tool---the pulmonary embolism (PE) risk calculator---for PE risk stratification in the emergency department that incorporates a behavior theory--informed nudge to address identified behavioral barriers to use. Methods: All study activities took place at a large academic health system in the New York City metropolitan area. Our study used a user-centered and behavior theory--based approach to achieve the following two aims: (1) use mixed methods to identify health care provider barriers to the use of an active CDS tool for PE risk stratification and (2) develop a new CDS tool---the PE risk calculator---that addresses behavioral barriers to health care providers' adoption of CDS by incorporating nudges into the user interface. These aims were guided by the revised Observational Research Behavioral Information Technology model. A total of 50 clinicians who used the original version of the tool were surveyed with a quantitative instrument that we developed based on a behavior theory framework---the Capability-Opportunity-Motivation-Behavior framework. A semistructured interview guide was developed based on the survey responses. Inductive methods were used to analyze interview session notes and audio recordings from 12 interviews. Revised versions of the tool were developed that incorporated nudges. Results: Functional prototypes were developed by using Axure PRO (Axure Software Solutions) software and usability tested with end users in an iterative agile process (n=10). The tool was redesigned to address 4 identified major barriers to tool use; we included 2 nudges and a default. The 6-month pilot trial for the tool was launched on October 1, 2021. Conclusions: Clinicians highlighted several important psychological and behavioral barriers to CDS use. Addressing these barriers, along with conducting traditional usability testing, facilitated the development of a tool with greater potential to transform clinical care. The tool will be tested in a prospective pilot trial. International Registered Report Identifier (IRRID): DERR1-10.2196/42653 ",
doi="10.2196/42653",
url="https://www.researchprotocols.org/2023/1/e42653",
url="http://www.ncbi.nlm.nih.gov/pubmed/36652293"
}


@Article{info:doi/10.2196/40446,
author="Barnes, Keely
and Sveistrup, Heidi
and Bayley, Mark
and Egan, Mary
and Rathbone, Michel
and Taljaard, Monica
and Marshall, Shawn",
title="Identification of Clinical Measures to Use in a Virtual Concussion Assessment: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2022",
month="Dec",
day="22",
volume="11",
number="12",
pages="e40446",
keywords="telehealth",
keywords="virtual care",
keywords="concussion",
keywords="mild traumatic brain injury",
keywords="assessment",
keywords="examination",
abstract="Background: Workplace concussions can have a significant impact on workers. The impact of concussion symptoms, combined with challenges associated with clinical environments that are loud, bright, and busy, create barriers to conducting effective in-person assessments. Although the opportunity for remote care in rural communities has long been recognized, the COVID-19 pandemic has catalyzed the transition to virtual assessments and care into the mainstream. With this rapid shift, many clinicians have been completing remote assessments. However, the approaches and measures used in these assessments have not yet been standardized. Furthermore, the psychometric properties of the assessments when completed remotely using videoconference have not yet been documented. Objective: Through this mixed methods study, we aim to (1) identify the concussion assessment measures clinicians are currently using in person and are most relevant to the following 5 physical domains: neurological examination (ie, cranial nerve, coordination, motor, and sensory skills), cervical spine, vestibular, oculomotor, and effort assessment; (2) document the psychometric properties of the measures identified; (3) identify measures that appear feasible in a virtual context; and (4) identify practical and technical barriers or challenges, facilitators, and benefits to conducting or engaging in virtual concussion assessments. Methods: This study will follow a sequential mixed methods design using a survey and Delphi approach, working groups with expert clinicians, and focus groups with experienced clinicians and people living with concussions. Our target sample sizes are 50 clinicians for the Delphi surveys, 4 clinician-participants for the working group, and 5-7 participants for each focus group (roughly 6-10 total groups being planned with at least two groups consisting of people living with concussions). The results from this study will inform the decision regarding the measures that should be included in a virtual assessment tool kit to be tested in a future planned prospective evaluation study. Results: The study is expected to be completed by January 2023. Conclusions: This mixed methods study will document the clinical measures that are currently used in person and will identify those that are most relevant to assessing the physical domains impacted by concussions. Potential feasibility of using these measures in a virtual context will be explored. International Registered Report Identifier (IRRID): DERR1-10.2196/40446 ",
doi="10.2196/40446",
url="https://www.researchprotocols.org/2022/12/e40446",
url="http://www.ncbi.nlm.nih.gov/pubmed/36548031"
}


@Article{info:doi/10.2196/42853,
author="Wahyudi, Irfan
and Utomo, Prasetyo Chandra
and Djauzi, Samsuridjal
and Fathurahman, Muhamad
and Situmorang, Reinaldi Gerhard
and Rodjani, Arry
and Yonathan, Kevin
and Santoso, Budi",
title="Digital Pattern Recognition for the Identification of Various Hypospadias Parameters via an Artificial Neural Network: Protocol for the Development and Validation of a System and Mobile App",
journal="JMIR Res Protoc",
year="2022",
month="Nov",
day="25",
volume="11",
number="11",
pages="e42853",
keywords="artificial intelligence",
keywords="digital recognition",
keywords="hypospadias",
keywords="machine learning",
abstract="Background: Hypospadias remains the most prevalent congenital abnormality in boys worldwide. However, the limited infrastructure and number of pediatric urologists capable of diagnosing and managing the condition hinder the management of hypospadias in Indonesia. The use of artificial intelligence and image recognition is thought to be beneficial in improving the management of hypospadias cases in Indonesia. Objective: We aim to develop and validate a digital pattern recognition system and a mobile app based on an artificial neural network to determine various parameters of hypospadias. Methods: Hypospadias and normal penis images from an age-matched database will be used to train the artificial neural network. Images of 3 aspects of the penis (ventral, dorsal, and lateral aspects, which include the glans, shaft, and scrotum) will be taken from each participant. The images will be labeled with the following hypospadias parameters: hypospadias status, meatal location, meatal shape, the quality of the urethral plate, glans diameter, and glans shape. The data will be uploaded to train the image recognition model. Intrarater and interrater analyses will be performed, using the test images provided to the algorithm. Results: Our study is at the protocol development stage. A preliminary study regarding the system's development and feasibility will start in December 2022. The results of our study are expected to be available by the end of 2023. Conclusions: A digital pattern recognition system using an artificial neural network will be developed and designed to improve the diagnosis and management of patients with hypospadias, especially those residing in regions with limited infrastructure and health personnel. International Registered Report Identifier (IRRID): PRR1-10.2196/42853 ",
doi="10.2196/42853",
url="https://www.researchprotocols.org/2022/11/e42853",
url="http://www.ncbi.nlm.nih.gov/pubmed/36427238"
}


@Article{info:doi/10.2196/41015,
author="Jose, Ambily
and Sasseville, Maxime
and Dequanter, Samantha
and Gorus, Ellen
and Gigu{\`e}re, Anik
and Bourbonnais, Anne
and Abbasgholizadeh Rahimi, Samira
and Buyl, Ronald
and Gagnon, Marie-Pierre",
title="Existing eHealth Solutions for Older Adults Living With Neurocognitive Disorders (Mild and Major) or Dementia and Their Informal Caregivers: Protocol for an Environmental Scan",
journal="JMIR Res Protoc",
year="2022",
month="Nov",
day="4",
volume="11",
number="11",
pages="e41015",
keywords="dementia",
keywords="eHealth solutions",
keywords="mild cognitive impairment (MCI)",
keywords="environmental scan",
keywords="digital health",
abstract="Background: Dementia is one of the main public health priorities for current and future societies worldwide. Over the past years, eHealth solutions have added numerous promising solutions to enhance the health and wellness of people living with dementia-related cognitive problems and their primary caregivers. Previous studies have shown that an environmental scan identifies the knowledge-to-action gap meaningfully. This paper presents the protocol of an environmental scan to monitor the currently available eHealth solutions targeting dementia and other neurocognitive disorders against selected attributes. Objective: This study aims to identify the characteristics of currently available eHealth solutions recommended for older adults with cognitive problems and their informal caregivers. To inform the recommendations regarding eHealth solutions for these people, it is important to obtain a comprehensive view of currently available technologies and document their outcomes and conditions of success. Methods: We will perform an environmental scan of available eHealth solutions for older adults with cognitive impairment or dementia and their informal caregivers. Potential solutions will be initially identified from a previous systematic review. We will also conduct targeted searches for gray literature on Google and specialized websites covering the regions of Canada and Europe. Technological tools will be scanned based on a preformatted extraction grid. The relevance and efficiency based on the selected attributes will be assessed. Results: We will prioritize relevant solutions based on the needs and preferences identified from a qualitative study among older adults with cognitive impairment or dementia and their informal caregivers. Conclusions: This environmental scan will identify eHealth solutions that are currently available and scientifically appraised for older adults with cognitive impairment or dementia and their informal caregivers. This knowledge will inform the development of a decision support tool to assist older adults and their informal caregivers in their search for adequate eHealth solutions according to their needs and preferences based on trustable information. International Registered Report Identifier (IRRID): DERR1-10.2196/41015 ",
doi="10.2196/41015",
url="https://www.researchprotocols.org/2022/11/e41015",
url="http://www.ncbi.nlm.nih.gov/pubmed/36331531"
}


@Article{info:doi/10.2196/42651,
author="Lai, Byron
and Davis, Drew
and Young, Raven
and Swanson-Kimani, Erin
and Wozow, Cynthia
and Chaviano, Kelli
and Rimmer, H. James",
title="Group Telegaming Through Immersive Virtual Reality to Improve Mental Health Among Adolescents With Physical Disabilities: Pre- and Posttrial Protocol",
journal="JMIR Res Protoc",
year="2022",
month="Oct",
day="13",
volume="11",
number="10",
pages="e42651",
keywords="disability",
keywords="physical activity",
keywords="active video gaming",
keywords="mindfulness",
abstract="Background: Adolescents with physical disabilities have higher rates of mental health conditions and issues than adolescents without disabilities, and this disparity was exacerbated by the onset of the COVID-19 pandemic. They also have limited access to on-site programs and nearby peers. Objective: This pilot aims to investigate the potential effects of a low-dose multiplayer virtual reality telegaming program on depression, socialization, and loneliness among a cohort of children with physical disabilities. A secondary aim is to describe feasibility metrics, namely, recruitment and adherence rates and perceived program enjoyment and satisfaction. The tertiary aim is to describe behavioral mechanisms that affect participant adherence and social participation in the classes. Methods: This study is a single-group pre- and posttest--designed trial. A single cohort of 12 children with physical disabilities will pilot a 1-month program that includes 2 supervised 1-hour sessions per week of group-based exergaming. Participants will complete questionnaires before and after the program. The primary aim measures will include the Children's Depression Inventory 2 Short Form, a measure of feelings of depression, and the UCLA Loneliness Scale, a measure of both loneliness and social isolation. Secondary aim measures will include three posttest Likert scale questionnaires: perceived program enjoyment, program satisfaction, and satisfaction with multiplayer experiences. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underlie participation. Data will be reported descriptively and be supported by t tests as appropriate. Results: Recruitment procedures started in July 2022. All data are expected to be collected by January 2023. Full trial results are expected to be published by March 2023. Secondary analyses of data will be subsequently published. Conclusions: This trial tests a peer-to-peer virtual reality telegaming program that includes a completely remote enrollment, assessment, and intervention protocol. This program is accessible and short in duration and frequency, allowing it to be integrated into other interventions. Knowledge obtained from this study will inform the development of a larger trial for improving the mental health and well-being of adolescents with physical disabilities. Trial Registration: ClinicalTrials.gov NCT05259462; https://clinicaltrials.gov/ct2/show/NCT05259462 International Registered Report Identifier (IRRID): PRR1-10.2196/42651 ",
doi="10.2196/42651",
url="https://www.researchprotocols.org/2022/10/e42651",
url="http://www.ncbi.nlm.nih.gov/pubmed/36194864"
}


@Article{info:doi/10.2196/40189,
author="Pandria, Niki
and Petronikolou, Vasileia
and Lazaridis, Aristotelis
and Karapiperis, Christos
and Kouloumpris, Eleftherios
and Spachos, Dimitris
and Fachantidis, Anestis
and Vasiliou, Dimitris
and Vlahavas, Ioannis
and Bamidis, Panagiotis",
title="Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder: Protocol for a Nonrandomized Controlled Pilot Study",
journal="JMIR Res Protoc",
year="2022",
month="Sep",
day="28",
volume="11",
number="9",
pages="e40189",
keywords="attention deficit hyperactivity disorder (ADHD)",
keywords="machine learning",
keywords="web health",
keywords="serious games",
keywords="ADHD monitoring ",
abstract="Background: Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders during childhood; however, the diagnosis procedure remains challenging, as it is nonstandardized, multiparametric, and highly dependent on subjective evaluation of the perceived behavior. Objective: To address the challenges of existing procedures for ADHD diagnosis, the ADHD360 project aims to develop a platform for (1) early detection of ADHD by assessing the user's likelihood of having ADHD characteristics and (2) providing complementary training for ADHD management. Methods: A 2-phase nonrandomized controlled pilot study was designed to evaluate the ADHD360 platform, including ADHD and non-ADHD participants aged 7 to 16 years. At the first stage, an initial neuropsychological evaluation along with an interaction with the serious game developed (``Pizza on Time'') for approximately 30-45 minutes is performed. Subsequently, a 2-week behavior monitoring of the participants through the mADHD360 app is planned after a telephone conversation between the participants' parents and the psychologist, where the existence of any behaviors characteristic of ADHD that affect daily functioning is assessed. Once behavior monitoring is complete, the research team invites the participants to the second stage, where they play the game for a mean duration of 10 weeks (2 times per week). Once the serious game is finished, a second round of behavior monitoring is performed following the same procedures as the initial one. During the study, gameplay data were collected and preprocessed. The protocol of the pilot trials was initially designed for in-person participation, but after the COVID-19 outbreak, it was adjusted for remote participation. State-of-the-art machine learning (ML) algorithms were used to analyze labeled gameplay data aiming to detect discriminative gameplay patterns among the 2 groups (ADHD and non-ADHD) and estimate a player's likelihood of having ADHD characteristics. A schema including a train-test splitting with a 75:25 split ratio, k-fold cross-validation with k=3, an ML pipeline, and data evaluation were designed. Results: A total of 43 participants were recruited for this study, where 18 were diagnosed with ADHD and the remaining 25 were controls. Initial neuropsychological assessment confirmed that the participants in the ADHD group showed a deviation from the participants without ADHD characteristics. A preliminary analysis of collected data consisting of 30 gameplay sessions showed that the trained ML models achieve high performance (ie, accuracy up to 0.85) in correctly predicting the users' labels (ADHD or non-ADHD) from their gameplay session on the ADHD360 platform. Conclusions: ADHD360 is characterized by its notable capacity to discriminate player gameplay behavior as either ADHD or non-ADHD. Therefore, the ADHD360 platform could be a valuable complementary tool for early ADHD detection. Trial Registration: ClinicalTrials.gov NCT04362982; https://clinicaltrials.gov/ct2/show/NCT04362982 International Registered Report Identifier (IRRID): RR1-10.2196/40189 ",
doi="10.2196/40189",
url="https://www.researchprotocols.org/2022/9/e40189",
url="http://www.ncbi.nlm.nih.gov/pubmed/36169998"
}


@Article{info:doi/10.2196/40317,
author="Meinert, Edward
and Milne-Ives, Madison
and Chaudhuri, Ray K.
and Harding, Tracey
and Whipps, John
and Whipps, Susan
and Carroll, Camille",
title="The Impact of a Digital Artificial Intelligence System on the Monitoring and Self-management of Nonmotor Symptoms in People With Parkinson Disease: Proposal for a Phase 1 Implementation Study",
journal="JMIR Res Protoc",
year="2022",
month="Sep",
day="26",
volume="11",
number="9",
pages="e40317",
keywords="Parkinson disease",
keywords="self-management",
keywords="telemedicine",
keywords="artificial intelligence",
abstract="Background: Nonmotor symptoms of Parkinson disease are a major factor of disease burden but are often underreported in clinical appointments. A digital tool has been developed to support the monitoring and management of nonmotor symptoms. Objective: The aim of this study is to establish evidence of the impact of the system on patient confidence, knowledge, and skills for self-management of nonmotor symptoms, symptom burden, and quality of life of people with Parkinson and their care partners. It will also evaluate the usability, acceptability, and potential for adoption of the system for people with Parkinson, care partners, and health care professionals. Methods: A mixed methods implementation and feasibility study based on the nonadoption, abandonment, scale-up, spread, and sustainability framework will be conducted with 60 person with Parkinson--care partner dyads and their associated health care professionals. Participants will be recruited from outpatient clinics at the University Hospitals Plymouth NHS Trust Parkinson service. The primary outcome, patient activation, will be measured over the 12-month intervention period; secondary outcomes include the system's impact on health and well-being outcomes, safety, usability, acceptability, engagement, and costs. Semistructured interviews with a subset of participants will gather a more in-depth understanding of user perspectives and experiences with the system. Repeated measures analysis of variance will analyze change over time and thematic analysis will be conducted on qualitative data. The study was peer reviewed by the Parkinson's UK Non-Drug Approaches grant board and is pending ethical approval. Results: The study won funding in August 2021; data collection is expected to begin in December 2022. Conclusions: The study's success criteria will be affirming evidence regarding the system's feasibility, usability and acceptability, no serious safety risks identified, and an observed positive impact on patient activation. Results will be disseminated in academic peer-reviewed journals and in platforms and formats that are accessible to the general public, guided by patient and public collaborators. Trial Registration: ClinicalTrials.gov NCT05414071; https://clinicaltrials.gov/ct2/show/NCT05414071 International Registered Report Identifier (IRRID): PRR1-10.2196/40317 ",
doi="10.2196/40317",
url="https://www.researchprotocols.org/2022/9/e40317",
url="http://www.ncbi.nlm.nih.gov/pubmed/36155396"
}


@Article{info:doi/10.2196/41152,
author="Athanasiou, Alkinoos
and Mitsopoulos, Konstantinos
and Praftsiotis, Apostolos
and Astaras, Alexander
and Antoniou, Panagiotis
and Pandria, Niki
and Petronikolou, Vasileia
and Kasimis, Konstantinos
and Lyssas, George
and Terzopoulos, Nikos
and Fiska, Vasilki
and Kartsidis, Panagiotis
and Savvidis, Theodoros
and Arvanitidis, Athanasios
and Chasapis, Konstantinos
and Moraitopoulos, Alexandros
and Nizamis, Kostas
and Kalfas, Anestis
and Iakovidis, Paris
and Apostolou, Thomas
and Magras, Ioannis
and Bamidis, Panagiotis",
title="Neurorehabilitation Through Synergistic Man-Machine Interfaces Promoting Dormant Neuroplasticity in Spinal Cord Injury: Protocol for a Nonrandomized Controlled Trial",
journal="JMIR Res Protoc",
year="2022",
month="Sep",
day="13",
volume="11",
number="9",
pages="e41152",
keywords="body-machine interface",
keywords="brain-computer interface",
keywords="neural rehabilitation",
keywords="serious games",
keywords="spinal cord injury",
keywords="wearable robotics",
abstract="Background: Spinal cord injury (SCI) constitutes a major sociomedical problem, impacting approximately 0.32-0.64 million people each year worldwide; particularly, it impacts young individuals, causing long-term, often irreversible disability. While effective rehabilitation of patients with SCI remains a significant challenge, novel neural engineering technologies have emerged to target and promote dormant neuroplasticity in the central nervous system. Objective: This study aims to develop, pilot test, and optimize a platform based on multiple immersive man-machine interfaces offering rich feedback, including (1) visual motor imagery training under high-density electroencephalographic recording, (2) mountable robotic arms controlled with a wireless brain-computer interface (BCI), (3) a body-machine interface (BMI) consisting of wearable robotics jacket and gloves in combination with a serious game (SG) application, and (4) an augmented reality module. The platform will be used to validate a self-paced neurorehabilitation intervention and to study cortical activity in chronic complete and incomplete SCI at the cervical spine. Methods: A 3-phase pilot study (clinical trial) was designed to evaluate the NeuroSuitUp platform, including patients with chronic cervical SCI with complete and incomplete injury aged over 14 years and age-/sex-matched healthy participants. Outcome measures include BCI control and performance in the BMI-SG module, as well as improvement of functional independence, while also monitoring neuropsychological parameters such as kinesthetic imagery, motivation, self-esteem, depression and anxiety, mental effort, discomfort, and perception of robotics. Participant enrollment into the main clinical trial is estimated to begin in January 2023 and end by December 2023. Results: A preliminary analysis of collected data during pilot testing of BMI-SG by healthy participants showed that the platform was easy to use, caused no discomfort, and the robotics were perceived positively by the participants. Analysis of results from the main clinical trial will begin as recruitment progresses and findings from the complete analysis of results are expected in early 2024. Conclusions: Chronic SCI is characterized by irreversible disability impacting functional independence. NeuroSuitUp could provide a valuable complementary platform for training in immersive rehabilitation methods to promote dormant neural plasticity. Trial Registration: ClinicalTrials.gov NCT05465486; https://clinicaltrials.gov/ct2/show/NCT05465486 International Registered Report Identifier (IRRID): PRR1-10.2196/41152 ",
doi="10.2196/41152",
url="https://www.researchprotocols.org/2022/9/e41152",
url="http://www.ncbi.nlm.nih.gov/pubmed/36099009"
}


@Article{info:doi/10.2196/39010,
author="Young, S. Alexander
and Choi, Abigail
and Cannedy, Shay
and Hoffmann, Lauren
and Levine, Lionel
and Liang, Li-Jung
and Medich, Melissa
and Oberman, Rebecca
and Olmos-Ochoa, T. Tanya",
title="Passive Mobile Self-tracking of Mental Health by Veterans With Serious Mental Illness: Protocol for a User-Centered Design and Prospective Cohort Study",
journal="JMIR Res Protoc",
year="2022",
month="Aug",
day="5",
volume="11",
number="8",
pages="e39010",
keywords="serious mental illness",
keywords="mobile health",
keywords="mental health",
keywords="passive sensing",
keywords="health informatics",
keywords="behavior",
keywords="sensor",
keywords="self-tracking",
keywords="predict",
keywords="assessment",
abstract="Background: Serious mental illnesses (SMI) are common, disabling, and challenging to treat, requiring years of monitoring and treatment adjustments. Stress or reduced medication adherence can lead to rapid worsening of symptoms and behaviors. Illness exacerbations and relapses generally occur with little or no clinician awareness in real time, leaving limited opportunity to modify treatments. Previous research suggests that passive mobile sensing may be beneficial for individuals with SMI by helping them monitor mental health status and behaviors, and quickly detect worsening mental health for prompt assessment and intervention. However, there is too little research on its feasibility and acceptability and the extent to which passive data can predict changes in behaviors or symptoms. Objective: The aim of this research is to study the feasibility, acceptability, and safety of passive mobile sensing for tracking behaviors and symptoms of patients in treatment for SMI, as well as developing analytics that use passive data to predict changes in behaviors and symptoms. Methods: A mobile app monitors and transmits passive mobile sensor and phone utilization data, which is used to track activity, sociability, and sleep in patients with SMI. The study consists of a user-centered design phase and a mobile sensing phase. In the design phase, focus groups, interviews, and usability testing inform further app development. In the mobile sensing phase, passive mobile sensing occurs with participants engaging in weekly assessments for 9 months. Three- and nine-month interviews study the perceptions of passive mobile sensing and ease of app use. Clinician interviews before and after the mobile sensing phase study the usefulness and feasibility of app utilization in clinical care. Predictive analytic models are built, trained, and selected, and make use of machine learning methods. Models use sensor and phone utilization data to predict behavioral changes and symptoms. Results: The study started in October 2020. It has received institutional review board approval. The user-centered design phase, consisting of focus groups, usability testing, and preintervention clinician interviews, was completed in June 2021. Recruitment and enrollment for the mobile sensing phase began in October 2021. Conclusions: Findings may inform the development of passive sensing apps and self-tracking in patients with SMI, and integration into care to improve assessment, treatment, and patient outcomes. Trial Registration: ClinicalTrials.gov NCT05023252; https://clinicaltrials.gov/ct2/show/NCT05023252 International Registered Report Identifier (IRRID): DERR1-10.2196/39010 ",
doi="10.2196/39010",
url="https://www.researchprotocols.org/2022/8/e39010",
url="http://www.ncbi.nlm.nih.gov/pubmed/35930336"
}


@Article{info:doi/10.2196/38379,
author="Gerritzen, Vera Esther
and McDermott, Orii
and Orrell, Martin",
title="Development of Best Practice Guidance on Online Peer Support for People With Young Onset Dementia: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2022",
month="Jul",
day="5",
volume="11",
number="7",
pages="e38379",
keywords="young onset dementia",
keywords="peer support",
keywords="eHealth",
keywords="social health",
keywords="mixed methods",
abstract="Background: Many people with young onset dementia (YOD) may feel isolated. Peer support has the potential to improve social health, but the inconsistent availability of age-appropriate, in-person (peer) support services for people with YOD suggests that many people with YOD miss out on the potential benefits. Online peer support could be useful, as it overcomes geographical barriers, offers a variety of options, and adjusts to various needs and preferences. Objective: Our study aims to develop evidence-based best practice guidance on online peer support for people with YOD and group facilitators to improve online peer support for people with YOD. Methods: Our mixed methods study consists of 4 phases and follows the guidelines of the Medical Research Council on complex interventions. Each phase consists of multiple substudies. The study focuses on the development stage of the Medical Research Council framework and additionally develops a plan for the feasibility/piloting, evaluation, and implementation stages. The participants are people living with YOD and peer support facilitators. The qualitative research methods include interviews, focus groups, and open questions in a web-based survey. The quantitative methods include a web-based survey consisting of existing outcome measures. Results: The study is funded by the European Union's Horizon 2020 research and innovation program under the Marie Sk?odowska-Curie Actions -- Innovative Training Networks (H2020-MSCA-ITN-2018; grant agreement number: 813196), and it received ethical approval from the London Bromley Research Ethics Committee (reference number: 21/LO/0248) in April 2021. Recruitment started in May 2021. Data collection and analysis are expected to be finished by September 2022. Conclusions: The best practice guidance can provide people with YOD with tailored and evidence-based information about online peer support, and it will be disseminated locally (in the United Kingdom) and internationally through dementia organizations, research networks, and academic institutions. International Registered Report Identifier (IRRID): DERR1-10.2196/38379 ",
doi="10.2196/38379",
url="https://www.researchprotocols.org/2022/7/e38379",
url="http://www.ncbi.nlm.nih.gov/pubmed/35788470"
}


@Article{info:doi/10.2196/39586,
author="Cole, Amy
and Richardson, R. Daniel
and Adapa, Karthik
and Khasawneh, Amro
and Crossnohere, Norah
and Bridges, P. John F.
and Mazur, Lukasz",
title="Development of a Patient-Centered Preference Tool for Patients With Hematologic Malignancies: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2022",
month="Jun",
day="29",
volume="11",
number="6",
pages="e39586",
keywords="co-design",
keywords="informed decision making",
keywords="mHealth",
keywords="electronic health care tools",
keywords="shared decision making",
keywords="patient engagement",
keywords="hematologic malignancies",
abstract="Background: The approval of novel therapies for patients diagnosed with hematologic malignancies have improved survival outcomes but increased the challenge of aligning chemotherapy choices with patient preferences. We previously developed paper versions of a discrete choice experiment (DCE) and a best-worst scaling (BWS) instrument to quantify the treatment outcome preferences of patients with hematologic malignancies to inform shared decision making. Objective: We aim to develop an electronic health care tool (EHT) to guide clinical decision making that uses either a BWS or DCE instrument to capture patient preferences. The primary objective of this study is to use both qualitative and quantitative methods to evaluate the perceived usability, cognitive workload (CWL), and performance of electronic prototypes that include the DCE and BWS instrument. Methods: This mixed methods study includes iterative co-design methods that will involve healthy volunteers, patient-caregiver pairs, and health care workers to evaluate the perceived usability, CWL, and performance of tasks within distinct prototypes. Think-aloud sessions and semistructured interviews will be conducted to collect qualitative data to develop an affinity diagram for thematic analysis. Validated assessments (Post-Study System Usability Questionnaire [PSSUQ] and the National Aeronautical and Space Administration's Task Load Index [NASA-TLX]) will be used to evaluate the usability and CWL required to complete tasks within the prototypes. Performance assessments of the DCE and BWS will include the evaluation of tasks using the Single Easy Questionnaire (SEQ), time to complete using the prototype, and the number of errors. Additional qualitative assessments will be conducted to gather participants' feedback on visualizations used in the Personalized Treatment Preferences Dashboard that provides a representation of user results after completing the choice tasks within the prototype. Results: Ethical approval was obtained in June 2021 from the Institutional Review Board of the University of North Carolina at Chapel Hill. The DCE and BWS instruments were developed and incorporated into the PRIME (Preference Reporting to Improve Management and Experience) prototype in early 2021 and prototypes were completed by June 2021. Heuristic evaluations were conducted in phase 1 and completed by July 2021. Recruitment of healthy volunteers began in August 2021 and concluded in September 2021. In December 2021, our findings from phase 2 were accepted for publication. Phase 3 recruitment began in January 2022 and is expected to conclude in September 2022. The data analysis from phase 3 is expected to be completed by November 2022. Conclusions: Our findings will help differentiate the usability, CWL, and performance of the DCE and BWS within the prototypes. These findings will contribute to the optimization of the prototypes, leading to the development of an EHT that helps facilitate shared decision making. This evaluation will inform the development of EHTs to be used clinically with patients and health care workers. International Registered Report Identifier (IRRID): DERR1-10.2196/39586 ",
doi="10.2196/39586",
url="https://www.researchprotocols.org/2022/6/e39586",
url="http://www.ncbi.nlm.nih.gov/pubmed/35767340"
}


@Article{info:doi/10.2196/34537,
author="Bernaerts, Sylvie
and De Witte, J. Nele A.
and Van der Auwera, Vicky
and Bonroy, Bert
and Muraru, Luiza
and Bamidis, Panagiotis
and Frantzidis, Christos
and Kourtidou-Papadeli, Chrysoula
and Azevedo, Nancy
and Garatea, Jokin
and Mu{\~n}oz, Idoia
and Almeida, Rosa
and Losada, Raquel
and Fung, Joyce
and Kehayia, Eva
and Lamontagne, Anouk
and de Guise, Elaine
and Duclos, Cyril
and Higgins, Johanne
and Nadeau, Sylvie
and Beaudry, Lucie
and Konstantinidis, Evdokimos",
title="Rehabilitation Supported by Technology: Protocol for an International Cocreation and User Experience Study",
journal="JMIR Res Protoc",
year="2022",
month="Mar",
day="10",
volume="11",
number="3",
pages="e34537",
keywords="cocreation",
keywords="harmonization",
keywords="living lab",
keywords="rehabilitation",
keywords="small-scale real-life testing",
keywords="technology",
abstract="Background: Living labs in the health and well-being domain have become increasingly common over the past decade but vary in available infrastructure, implemented study designs, and outcome measures. The Horizon 2020 Project Virtual Health and Wellbeing Living Lab Infrastructure aims to harmonize living lab procedures and open living lab infrastructures to facilitate and promote research activities in the health and well-being domain in Europe and beyond. This protocol will describe the design of a joint research activity, focusing on the use of innovative technology for both rehabilitation interventions and data collection in a rehabilitation context. Objective: With this joint research activity, this study primarily aims to gain insight into each living lab's infrastructure and procedures to harmonize health and well-being living lab procedures and infrastructures in Europe and beyond, particularly in the context of rehabilitation. Secondarily, this study aims to investigate the potential of innovative technologies for rehabilitation through living lab methodologies. Methods: This study has a mixed methods design comprising multiple phases. There are two main phases of data collection: cocreation (phase 1) and small-scale pilot studies (phase 2), which are preceded by a preliminary harmonization of procedures among the different international living labs. An intermediate phase further allows the implementation of minor adjustments to the intervention or protocol depending on the input that was obtained in the cocreation phase. A total of 6 small-scale pilot studies using innovative technologies for intervention or data collection will be performed across 4 countries. The target study sample comprises patients with stroke and older adults with mild cognitive impairment. The third and final phases involve Delphi procedures to reach a consensus on harmonized procedures and protocols. Results: Phase 1 data collection will begin in March 2022, and phase 2 data collection will begin in June 2022. Results will include the output of the cocreation sessions, small-scale pilot studies, and advice on harmonizing procedures and protocols for health and well-being living labs focusing on rehabilitation. Conclusions: The knowledge gained by the execution of this research will lead to harmonized procedures and protocols in a rehabilitation context for health and well-being living labs in Europe and beyond. In addition to the harmonized procedures and protocols in rehabilitation, we will also be able to provide new insights for improving the implementation of innovative technologies in rehabilitation. International Registered Report Identifier (IRRID): PRR1-10.2196/34537 ",
doi="10.2196/34537",
url="https://www.researchprotocols.org/2022/3/e34537",
url="http://www.ncbi.nlm.nih.gov/pubmed/35266874"
}


@Article{info:doi/10.2196/34885,
author="Torres, Silva Thiago
and Jalil, Moreira Emilia
and Coelho, Esteves Lara
and Bezerra, Barros Daniel Rodrigues
and Jalil, Moreira Cristina
and Hoagland, Brenda
and Cardoso, Wagner Sandra
and Arayasirikul, Sean
and Veloso, Gon{\c{c}}alves Valdilea
and Wilson, C. Erin
and McFarland, Willi
and Grinsztejn, Beatriz",
title="A Technology-Based Intervention Among Young Men Who Have Sex With Men and Nonbinary People (The Conectad@s Project): Protocol for A Vanguard Mixed Methods Study",
journal="JMIR Res Protoc",
year="2022",
month="Jan",
day="13",
volume="11",
number="1",
pages="e34885",
keywords="sexual and gender minorities",
keywords="young MSM",
keywords="Brazil",
keywords="HIV prevention",
keywords="technology-based adherence intervention",
keywords="HIV",
abstract="Background: In many parts of the world, including Brazil, uptake for biomedical interventions has been insufficient to reverse the HIV epidemic among key populations at high risk for HIV, including men who have sex with men. Young MSM (YMSM), particularly Black YMSM, have high HIV incidence, low viral suppression, and low preexposure prophylaxis (PrEP) uptake and adherence. Therefore, novel approaches to increase the HIV biomedical interventions uptake by YMSM are urgently needed. Objective: We describe the Conectad@s Project, which aims to: (1) estimate the prevalence and incidence of HIV and other sexually transmitted infections, the onset of sexual risk behavior, and barriers to biomedical interventions among YMSM aged 18 to 24 years in Rio de Janeiro, Brazil; and (2) conduct a technology-based adherence intervention study to promote a rapid linkage of YMSM to HIV care or prevention, and support and sustain adherence. Methods: A cross-sectional survey will be conducted with 400 YMSM recruited using respondent-driven sampling (RDS) adapted for social media-based sampling, preceded by a formative phase. HIV and sexually transmitted infections testing will be conducted, including early HIV infection biomarker detection. Behavioral, partnership, network, and structural measures will be collected through structured questionnaires. All individuals recruited for the survey will have access to HIV risk assessment, antiretroviral therapy (ART), PrEP, prevention counseling, and a technology-based adherence intervention. Those who accept the adherence intervention will receive weekly text messages via a social networking app (WhatsApp) for 24 weeks, with follow-up data collected over 48 weeks. Results: The Conectad@s project has been approved by our local institutional review board (\#CAAE 26086719.0.0000.4262) in accordance with all applicable regulations. Questionnaires for the RDS survey and intervention were developed and tested in 2020, formative interviews were conducted in January and February 2021 to guide the development of the RDS, and enrollment is planned to begin in early 2022. Conclusions: The Conectad@s Project is a vanguard study that, for the first time, will apply digital RDS to sample and recruit YMSM in Brazil and rapidly connect them to ART, PrEP, or prevention counseling through a technology-based adherence intervention. RDS will allow us to estimate HIV prevalence among YMSM and measure HIV infection biomarkers in the context of the onset of risky behavior. The data will lay the groundwork to adapt and implement HIV prevention strategies, identify barriers to the earliest HIV infection diagnosis, immediate ART or PrEP initiation, and detect new clusters of HIV transmission. International Registered Report Identifier (IRRID): DERR1-10.2196/34885 ",
doi="10.2196/34885",
url="https://www.researchprotocols.org/2022/1/e34885",
url="http://www.ncbi.nlm.nih.gov/pubmed/35023848"
}


@Article{info:doi/10.2196/34567,
author="Santonen, Teemu
and Petsani, Despoina
and Julin, Mikko
and Garschall, Markus
and Kropf, Johannes
and Van der Auwera, Vicky
and Bernaerts, Sylvie
and Losada, Raquel
and Almeida, Rosa
and Garatea, Jokin
and Mu{\~n}oz, Idoia
and Nagy, Eniko
and Kehayia, Eva
and de Guise, Elaine
and Nadeau, Sylvie
and Azevedo, Nancy
and Segkouli, Sofia
and Lazarou, Ioulietta
and Petronikolou, Vasileia
and Bamidis, Panagiotis
and Konstantinidis, Evdokimos",
title="Cocreating a Harmonized Living Lab for Big Data--Driven Hybrid Persona Development: Protocol for Cocreating, Testing, and Seeking Consensus",
journal="JMIR Res Protoc",
year="2022",
month="Jan",
day="6",
volume="11",
number="1",
pages="e34567",
keywords="Living Lab",
keywords="everyday living",
keywords="technology",
keywords="big data",
keywords="harmonization",
keywords="personas",
keywords="small-scale real-life testing",
keywords="mobile phone",
abstract="Background: Living Labs are user-centered, open innovation ecosystems based on a systematic user cocreation approach, which integrates research and innovation processes in real-life communities and settings. The Horizon 2020 Project VITALISE (Virtual Health and Wellbeing Living Lab Infrastructure) unites 19 partners across 11 countries. The project aims to harmonize Living Lab procedures and enable effective and convenient transnational and virtual access to key European health and well-being research infrastructures, which are governed by Living Labs. The VITALISE consortium will conduct joint research activities in the fields included in the care pathway of patients: rehabilitation, transitional care, and everyday living environments for older adults. This protocol focuses on health and well-being research in everyday living environments. Objective: The main aim of this study is to cocreate and test a harmonized research protocol for developing big data--driven hybrid persona, which are hypothetical user archetypes created to represent a user community. In addition, the use and applicability of innovative technologies will be investigated in the context of various everyday living and Living Lab environments. Methods: In phase 1, surveys and structured interviews will be used to identify the most suitable Living Lab methods, tools, and instruments for health-related research among VITALISE project Living Labs (N=10). A series of web-based cocreation workshops and iterative cowriting processes will be applied to define the initial protocols. In phase 2, five small-scale case studies will be conducted to test the cocreated research protocols in various real-life everyday living settings and Living Lab infrastructures. In phase 3, a cross-case analysis grounded on semistructured interviews will be conducted to identify the challenges and benefits of using the proposed research protocols. Furthermore, a series of cocreation workshops and the consensus seeking Delphi study process will be conducted in parallel to cocreate and validate the acceptance of the defined harmonized research protocols among wider Living Lab communities. Results: As of September 30, 2021, project deliverables Ethics and safety manual and Living lab standard version 1 have been submitted to the European Commission review process. The study will be finished by March 2024. Conclusions: The outcome of this research will lead to harmonized procedures and protocols in the context of big data--driven hybrid persona development among health and well-being Living Labs in Europe and beyond. Harmonized protocols enable Living Labs to exploit similar research protocols, devices, hardware, and software for interventions and complex data collection purposes. Economies of scale and improved use of resources will speed up and improve research quality and offer novel possibilities for open data sharing, multidisciplinary research, and comparative studies beyond current practices. Case studies will also provide novel insights for implementing innovative technologies in the context of everyday Living Lab research. International Registered Report Identifier (IRRID): DERR1-10.2196/34567 ",
doi="10.2196/34567",
url="https://www.researchprotocols.org/2022/1/e34567",
url="http://www.ncbi.nlm.nih.gov/pubmed/34989697"
}


@Article{info:doi/10.2196/22125,
author="Dinsmore, John
and Hannigan, Caoimhe
and Smith, Suzanne
and Murphy, Emma
and Kuiper, L. Janneke M.
and O'Byrne, Emma
and Galvin, Mary
and Jacobs, An
and Sillevis Smitt, Myriam
and van Leeuwen, Cora
and McAleer, Patricia
and Tompkins, Lorraine
and Brady, Anne-Marie
and McCarron, Mary
and Doyle, Julie",
title="A Digital Health Platform for Integrated and Proactive Patient-Centered Multimorbidity Self-management and Care (ProACT): Protocol for an Action Research Proof-of-Concept Trial",
journal="JMIR Res Protoc",
year="2021",
month="Dec",
day="15",
volume="10",
number="12",
pages="e22125",
keywords="multimorbidity",
keywords="digital health",
keywords="chronic disease",
keywords="self-management",
keywords="older adults",
keywords="integrated care",
keywords="behaviour change",
keywords="mobile phone",
keywords="smart phone",
keywords="smart device",
abstract="Background: Multimorbidity is defined as the presence of two or more chronic diseases and associated comorbidities. There is a need to improve best practices around the provision of well-coordinated, person-centered care for persons with multimorbidities. Present health systems across the European Union (EU) focus on supporting a single-disease framework of care; the primary challenge is to create a patient-centric, integrated care ecosystem to understand and manage multimorbidity. ProACT is a large-scale project funded by the European Commission under the Horizon 2020 programme, that involved the design, development, and evaluation of a digital health platform to improve and advance home-based integrated care, and supported self-management, for older adults (aged ?65 years) living with multimorbidity. Objective: This paper describes the trial implementation protocol of a proof-of-concept digital health platform (ProACT) in 2 EU member states (Ireland and Belgium) to support older persons with multimorbidities self-managing at home, supported by their care network (CN). Methods: Research was conducted across 2 EU member states, Ireland and Belgium. A 12-month action research trial design, divided into 3 evaluation cycles and lasting 3 months each, with a reflective redesign and development phase of 1 month after cycles 1 and 2 was conducted. Participants were 120 (60/120, 50\% in Ireland and 60/120, 50\% in Belgium) older persons with multimorbidities diagnosed with two or more of the following chronic conditions: diabetes, chronic obstructive pulmonary disease, chronic heart failure, and cardiovascular diseases. With permission from persons with multimorbidities, members of their CN were invited to participate in the study. Persons with multimorbidities were provided with ProACT technologies (tablet, devices, or sensors) to support them in self-managing their conditions. CN members also received access to an app to remotely support their persons with multimorbidity. Qualitative and quantitative feedback and evaluation data from persons with multimorbidity and CN participants were collected across four time points: baseline (T1), at the end of each 3-month action research cycle (T2 and T3), and in a final posttrial interview (T4). Thematic analysis was used to analyze the qualitative interview data. Quantitative data were analyzed via platform use statistics (to assess engagement) and standardized questionnaires (using descriptive and inferential statistics). This study is approved by the ethics committees of Ireland and Belgium. Results: The trial implementation phase for this 44-month (2016-2019) funded study was April 2018 to June 2019. The trial outcomes are at various stages of publication since 2021. Conclusions: ProACT aims to co-design and develop a digital intervention with persons with multimorbidities and their CN, incorporating clinical guidelines with the state of the art in human-computer interaction, behavioral science, health psychology, and data analytic methods to deliver a digital health platform to advance self-management of multimorbidity at home, as part of a proactive, integrated model of supported person-centered care. International Registered Report Identifier (IRRID): RR1-10.2196/22125 ",
doi="10.2196/22125",
url="https://www.researchprotocols.org/2021/12/e22125",
url="http://www.ncbi.nlm.nih.gov/pubmed/34914613"
}


@Article{info:doi/10.2196/33495,
author="Fung, Kenneth
and Liu, JW Jenny
and Vahabi, Mandana
and Li, Tai-Wai Alan
and Zurowski, Mateusz
and Wong, Pui-Hing Josephine",
title="Pandemic Acceptance and Commitment to Empowerment Response (PACER) Training: Protocol for the Development and Rapid-Response Deployment",
journal="JMIR Res Protoc",
year="2021",
month="Dec",
day="6",
volume="10",
number="12",
pages="e33495",
keywords="COVID",
keywords="COVID-19",
keywords="coronavirus",
keywords="pandemic",
keywords="resilience",
keywords="acceptance commitment therapy",
keywords="group empowerment",
abstract="Background: During a global pandemic, it is critical to rapidly deploy a psychological intervention to support the mental health and resilience of highly affected individuals and communities. Objective: This is the rationale behind the development and implementation of the Pandemic Acceptance and Commitment to Empowerment Response (PACER) Training, an online, blended, skills building intervention to increase the resilience and well-being of participants while promoting their individual and collective empowerment and capacity building. Methods: Based on acceptance and commitment therapy (ACT) and social justice--based group empowerment psychoeducation (GEP), we developed the Acceptance and Commitment to Empowerment (ACE) model to enhance psychological resilience and collective empowerment. The PACER program consists of 6 online, interactive, self-guided modules complemented by 6 weekly, 90-minute, videoconference, facilitator-led, group sessions. Results: As of August 2021, a total of 325 participants had enrolled in the PACER program. Participants include frontline health care providers and Chinese-Canadian community members. Conclusions: The PACER program is an innovative intervention program with the potential for increasing resilience and empowerment while reducing mental distress during the pandemic. International Registered Report Identifier (IRRID): DERR1-10.2196/33495 ",
doi="10.2196/33495",
url="https://www.researchprotocols.org/2021/12/e33495",
url="http://www.ncbi.nlm.nih.gov/pubmed/34726602"
}


@Article{info:doi/10.2196/30525,
author="Trofholz, Amanda
and Tate, Allan
and Janowiec, Mark
and Fertig, Angela
and Loth, Katie
and de Brito, N. Junia
and Berge, Jerica",
title="Ecological Momentary Assessment of Weight-Related Behaviors in the Home Environment of Children From Low-Income and Racially and Ethnically Diverse Households: Development and Usability Study",
journal="JMIR Res Protoc",
year="2021",
month="Dec",
day="1",
volume="10",
number="12",
pages="e30525",
keywords="methods",
keywords="ecological momentary assessment",
keywords="weight-related behaviors",
keywords="racially and ethnically diverse",
keywords="children",
keywords="mobile phone",
abstract="Background: Ecological momentary assessment (EMA) is an innovative tool for capturing in-the-moment health behaviors as people go about their daily lives. EMA is an ideal tool to measure weight-related behaviors, such as parental feeding practices, stress, and dietary intake, as these occur on a daily basis and vary across time and context. A recent systematic review recommended standardized reporting of EMA design for studies that address weight-related behaviors. Objective: To answer the call for reporting study designs using EMA, this paper describes in detail the EMA design of the Family Matters study and how it was adapted over time to improve functionality and meet the needs of a racially, ethnically, and socioeconomically diverse sample. Methods: Family Matters is an incremental, 2-phased, mixed methods study, conducted with a racially and ethnically diverse, immigrant and refugee sample from largely low-income households, designed to examine risk and protective factors for child weight and weight-related behaviors in the home environment. The Family Matters study intentionally recruited White, Black, Hmong, Latino, Native American, and Somali parents with young children. Parents in phase 1 of the study completed 8 days of EMA on their smartphones, which included signal-contingent surveys (eg, asking about the parent's stress at the time of the survey), event-contingent surveys (eg, descriptions of the meal the child ate), and end-of-day surveys (eg, overall assessment of the child's day). Results: A detailed description of EMA strategies, protocols, and methods used in phase 1 of the Family Matters study is provided. Compliance with EMA surveys and participants' time spent completing EMA surveys are presented and stratified by race and ethnicity. In addition, lessons learned while conducting phase 1 EMA are shared to document how EMA methods were improved and expanded upon for phase 2 of the Family Matters study. Conclusions: The results from this study provided an important next step in identifying best practices for EMA use in assessing weight-related behaviors in the home environment. International Registered Report Identifier (IRRID): DERR1-10.2196/30525 ",
doi="10.2196/30525",
url="https://www.researchprotocols.org/2021/12/e30525",
url="http://www.ncbi.nlm.nih.gov/pubmed/34855612"
}


@Article{info:doi/10.2196/33589,
author="Cabral, F. Danylo
and Hinchman, A. Carrie
and Nunez, Christina
and Rice, Jordyn
and Loewenstein, A. David
and Cahalin, P. Lawrence
and Rundek, Tatjana
and Pascual-Leone, Alvaro
and Gomes-Osman, Joyce",
title="Harnessing Neuroplasticity to Promote Brain Health in Aging Adults: Protocol for the MOVE-Cog Intervention Study",
journal="JMIR Res Protoc",
year="2021",
month="Nov",
day="23",
volume="10",
number="11",
pages="e33589",
keywords="exercise",
keywords="neuroplasticity",
keywords="cognition",
keywords="brain health",
keywords="cardiorespiratory fitness",
keywords="cardiovascular function",
keywords="trophic factors",
keywords="telehealth",
keywords="aging adult",
abstract="Background: Extensive evidence supports a link between aerobic exercise and cognitive improvements in aging adults. A major limitation with existing research is the high variability in cognitive response to exercise. Our incomplete understanding of the mechanisms that influence this variability and the low adherence to exercise are critical knowledge gaps and major barriers for the systematic implementation of exercise for promoting cognitive health in aging. Objective: We aimed to provide an in-person and remotely delivered intervention study protocol with the main goal of informing the knowledge gap on the mechanistic action of exercise on the brain by characterizing important mechanisms of neuroplasticity, cardiorespiratory fitness response, and genetics proposed to underlie cognitive response to exercise. Methods: This is an open-label, 2-month, interventional study protocol in neurologically healthy sedentary adults. This study was delivered fully in-person and in remote options. Participants underwent a total of 30 sessions, including the screening session, 3 pretest (baseline) assessments, 24 moderate-to-vigorous aerobic exercise sessions, and 3 posttest assessments. We recruited participants aged 55 years and above, sedentary, and cognitively healthy. Primary outcomes were neuroplasticity, cognitive function, and cardiorespiratory fitness. Secondary outcomes included genetic factors, endothelium function, functional mobility and postural control, exercise questionnaires, depression, and sleep. We also explored study feasibility, exercise adherence, technology adaptability, and compliance of both in-person and remote protocols. Results: The recruitment phase and data collection of this study have concluded. Results are expected to be published by the end of 2021 or in early 2022. Conclusions: The data generated in these studies will introduce tangible parameters to guide the development of personalized exercise prescription models for maximal cognitive benefit in aging adults. Successful completion of the specific aims will enable researchers to acquire the appropriate expertise to design and conduct studies by testing personalized exercise interventions in person and remotely delivered, likely to be more effective at promoting cognitive health in aging adults. Trial Registration: ClinicalTrials.gov NCT03804528; http://clinicaltrials.gov/ct2/show/NCT03804528 International Registered Report Identifier (IRRID): RR1-10.2196/33589 ",
doi="10.2196/33589",
url="https://www.researchprotocols.org/2021/11/e33589",
url="http://www.ncbi.nlm.nih.gov/pubmed/34817393"
}


@Article{info:doi/10.2196/32521,
author="Horvath, Mark
and Grutman, Aurora
and O'Malley, S. Stephanie
and Gueorguieva, Ralitza
and Khan, Nashmia
and Brewer, A. Judson
and Garrison, A. Kathleen",
title="Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial",
journal="JMIR Res Protoc",
year="2021",
month="Nov",
day="16",
volume="10",
number="11",
pages="e32521",
keywords="smartband",
keywords="smartphone",
keywords="smoking",
keywords="mindfulness",
keywords="craving",
keywords="mHealth",
abstract="Background: Smoking is the leading cause of preventable death in the United States. Smoking cessation interventions delivered by smartphone apps are a promising tool for helping smokers quit. However, currently available smartphone apps for smoking cessation have not exploited their unique potential advantages to aid quitting. Notably, few to no available apps use wearable technologies, most apps require users to self-report their smoking, and few to no apps deliver treatment automatically contingent upon smoking. Objective: This pilot trial tests the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver brief mindfulness interventions in real time to reduce smoking. Methods: Daily smokers (N=100, ?5 cigarettes per day) wear a smartband for 60 days to monitor and detect smoking, notify them about their smoking events in real time, and deliver real-time brief mindfulness exercises triggered by detected smoking events or targeted at predicted smoking events. Smokers set a quit date at 30 days. A three-step intervention to reduce smoking is tested. First, participants wear a smartband to monitor and detect smoking, and notify them of smoking events in real time to bring awareness to smoking and triggers for 21 days. Next, a ``mindful smoking'' exercise is triggered by detected smoking events to bring a clear recognition of the actual effects of smoking for 7 days. Finally, after their quit date, a ``RAIN'' (recognize, allow, investigate, nonidentification) exercise is delivered to predicted smoking events (based on the initial 3 weeks of tracking smoking data) to help smokers learn to work mindfully with cravings rather than smoke for 30 days. The primary outcomes are feasibility measures of treatment fidelity, adherence, and acceptability. The secondary outcomes are smoking rates at end of treatment. Results: Recruitment for this trial started in May 2021 and will continue until November 2021 or until enrollment is completed. Data monitoring and management are ongoing for enrolled participants. The final 60-day end of treatment data is anticipated in January 2022. We expect that all trial results will be available in April 2022. Conclusions: Findings will provide data and information on the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver real-time brief mindfulness interventions, and whether the intervention warrants additional testing for smoking cessation. Trial Registration: ClinicalTrials.gov NCT03995225; https://clinicaltrials.gov/ct2/show/NCT03995225 International Registered Report Identifier (IRRID): DERR1-10.2196/32521 ",
doi="10.2196/32521",
url="https://www.researchprotocols.org/2021/11/e32521",
url="http://www.ncbi.nlm.nih.gov/pubmed/34783663"
}


@Article{info:doi/10.2196/33653,
author="Spitale, Giovanni
and Merten, Sonja
and Jafflin, Kristen
and Schwind, Bettina
and Kaiser-Grolimund, Andrea
and Biller-Andorno, Nikola",
title="A Novel Risk and Crisis Communication Platform to Bridge the Gap Between Policy Makers and the Public in the Context of the COVID-19 Crisis (PubliCo): Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2021",
month="Nov",
day="1",
volume="10",
number="11",
pages="e33653",
keywords="disease outbreaks",
keywords="coronavirus",
keywords="COVID-19 surveys",
keywords="COVID-19 questionnaires",
keywords="qualitative methods",
keywords="health literacy",
keywords="policy making",
keywords="risk and crisis communication",
keywords="COVID-19",
abstract="Background: Since the end of 2019, COVID-19 has had a significant impact on people around the globe. As governments institute more restrictive measures, public adherence could decrease and discontent may grow. Providing high-quality information and countering fake news are important. However, we also need feedback loops so that government officials can refine preventive measures and communication strategies. Policy makers need information---preferably based on real-time data---on people's cognitive, emotional, and behavioral reactions to public health messages and restrictive measures. PubliCo aims to foster effective and tailored risk and crisis communication as well as provide an assessment of the risks and benefits of prevention and control measures, since their effectiveness depends on public trust and cooperation. Objective: Our project aims to develop a tool that helps tackle the COVID-19 infodemic, with a focus on enabling a nuanced and in-depth understanding of public perception. The project adopts a transdisciplinary multistakeholder approach, including participatory citizen science. Methods: We aim to combine a literature and media review and analysis as well as empirical research using mixed methods, including an online survey and diary-based research, both of which are ongoing and continuously updated. Building on real-time data and continuous data collection, our research results will be highly adaptable to the evolving situation. Results: As of September 2021, two-thirds of the proposed tool is operational. The current development cycles are focusing on analytics, user experience, and interface refinement. We have collected a total of 473 responses through PubliCo Survey and 22 diaries through PubliCo Diaries. Conclusions: Pilot data show that PubliCo is a promising and efficient concept for bidirectional risk and crisis communication in the context of public health crises. Further data are needed to assess its function at a larger scale or in the context of an issue other than COVID-19. International Registered Report Identifier (IRRID): DERR1-10.2196/33653 ",
doi="10.2196/33653",
url="https://www.researchprotocols.org/2021/11/e33653",
url="http://www.ncbi.nlm.nih.gov/pubmed/34612823"
}


@Article{info:doi/10.2196/32789,
author="Psihogios, M. Alexandra
and Rabbi, Mashfiqui
and Ahmed, Annisa
and McKelvey, R. Elise
and Li, Yimei
and Laurenceau, Jean-Philippe
and Hunger, P. Stephen
and Fleisher, Linda
and Pai, LH Ahna
and Schwartz, A. Lisa
and Murphy, A. Susan
and Barakat, P. Lamia",
title="Understanding Adolescent and Young Adult 6-Mercaptopurine Adherence and mHealth Engagement During Cancer Treatment: Protocol for Ecological Momentary Assessment",
journal="JMIR Res Protoc",
year="2021",
month="Oct",
day="22",
volume="10",
number="10",
pages="e32789",
keywords="mHealth",
keywords="ecological momentary assessment",
keywords="adolescents",
keywords="young adults",
keywords="oncology",
keywords="cancer",
keywords="self-management",
keywords="mobile phone",
abstract="Background: Adolescents and young adults (AYAs) with cancer demonstrate suboptimal oral chemotherapy adherence, increasing their risk of cancer relapse. It is unclear how everyday time-varying contextual factors (eg, mood) affect their adherence, stalling the development of personalized mobile health (mHealth) interventions. Poor engagement is also a challenge across mHealth trials; an effective adherence intervention must be engaging to promote uptake. Objective: This protocol aims to determine the temporal associations between daily contextual factors and 6-mercaptopurine (6-MP) adherence and explore the proximal impact of various engagement strategies on ecological momentary assessment survey completion. Methods: At the Children's Hospital of Philadelphia, AYAs with acute lymphoblastic leukemia or lymphoma who are prescribed prolonged maintenance chemotherapy that includes daily oral 6-MP are eligible, along with their matched caregivers. Participants will use an ecological momentary assessment app called ADAPTS (Adherence Assessments and Personalized Timely Support)---a version of an open-source app that was modified for AYAs with cancer through a user-centered process---and complete surveys in bursts over 6 months. Theory-informed engagement strategies will be microrandomized to estimate the causal effects on proximal survey completion. Results: With funding from the National Cancer Institute and institutional review board approval, of the proposed 30 AYA-caregiver dyads, 60\% (18/30) have been enrolled; of the 18 enrolled, 15 (83\%) have completed the study so far. Conclusions: This protocol represents an important first step toward prescreening tailoring variables and engagement components for a just-in-time adaptive intervention designed to promote both 6-MP adherence and mHealth engagement. International Registered Report Identifier (IRRID): DERR1-10.2196/32789 ",
doi="10.2196/32789",
url="https://www.researchprotocols.org/2021/10/e32789",
url="http://www.ncbi.nlm.nih.gov/pubmed/34677129"
}


@Article{info:doi/10.2196/31241,
author="Adams, Leslie
and Igbinedion, Godwin
and DeVinney, Aubrey
and Azasu, Enoch
and Nestadt, Paul
and Thrul, Johannes
and Joe, Sean",
title="Assessing the Real-time Influence of Racism-Related Stress and Suicidality Among Black Men: Protocol for an Ecological Momentary Assessment Study",
journal="JMIR Res Protoc",
year="2021",
month="Oct",
day="20",
volume="10",
number="10",
pages="e31241",
keywords="Black men",
keywords="suicide",
keywords="racism",
keywords="ecological momentary assessment",
abstract="Background: Suicide is the third leading cause of death among Black adults aged 18-35 years. Although men represent a majority of suicide deaths among Black adults, less is known regarding the extent to which unique cultural stressors, such as racism-related stress (eg, racial discrimination), are salient in exacerbating suicide risk among Black men. Moreover, few studies examine the daily influence of racism-related stressors on suicide outcomes using real-time smartphone-based approaches. Smartphone-based mobile health approaches using ecological momentary assessments (EMA) provide an opportunity to assess and characterize racism-related stressors as a culturally sensitive suicide risk factor among Black young adult men. Objective: The goal of this study is to describe a protocol development process that aims to capture real-time racism-related stressors and suicide outcomes using a smartphone-based EMA platform (MetricWire). Methods: Guided by the Interpersonal Theory of Suicide (ITS), we developed a brief EMA protocol using a multiphased approach. First, we conducted a literature review to identify brief measures previously used in EMA studies, with special emphasis on studies including Black participants. The identified measures were then shortened to items with the highest construct validity (eg, factor loadings) and revised to reflect momentary or daily frequency. Feasibility and acceptability of the study protocol will be assessed using self-report survey and qualitative responses. To protect participants from harm, a three-tier safety protocol was developed to identify participants with moderate, elevated, and acute risk based on EMA survey response to trigger outreach by the study coordinator. Results: The final EMA protocol, which will be completed over a 7-day period, is comprised of 15 questions administered 4 times per day and a daily questionnaire of 22 items related to sleep-related impairment and disruption, as well as racism-related stress. Study recruitment is currently underway. We anticipate the study will be completed in February 2023. Dissemination will be conducted through peer-reviewed publications and conference presentations. Conclusions: This protocol will address gaps in our understanding of Black men's suicide outcomes in the social contexts that they regularly navigate and will clarify the temporal role of racism-related stressors that influence suicidal outcomes. International Registered Report Identifier (IRRID): PRR1-10.2196/31241 ",
doi="10.2196/31241",
url="https://www.researchprotocols.org/2021/10/e31241",
url="http://www.ncbi.nlm.nih.gov/pubmed/34668869"
}


@Article{info:doi/10.2196/31211,
author="Fung, Po-Lun Kenneth
and Vahabi, Mandana
and Moosapoor, Masoomeh
and Akbarian, Abdolreza
and Jing-Wen Liu, Jenny
and Wong, Pui-Hing Josephine",
title="Implementation of an Internet-Based Acceptance and Commitment Therapy for Promoting Mental Health Among Migrant Live-in Caregivers in Canada: Protocol",
journal="JMIR Res Protoc",
year="2021",
month="Sep",
day="13",
volume="10",
number="9",
pages="e31211",
keywords="migrant live-in caregiver",
keywords="women",
keywords="mental health",
keywords="acceptance commitment therapy",
keywords="resiliency",
keywords="empowerment",
abstract="Background: Psychological distress, isolation, feelings of powerlessness, and limited social support are realities faced by temporary migrant live-in caregivers in Canada. Furthermore, they experience multiple barriers in accessing mental health services due to their long work hours, limited knowledge of health resources, precarious employment, and immigration status. Objective: The Women Empowerment - Caregiver Acceptance \& Resilience E-Learning (WE2CARE) project is a pilot intervention research project that aims to promote the mental well-being and resiliency of migrant live-in caregivers. The objectives include exploring the effectiveness of this program in achieving the following: (1) reducing psychological distress (depression, anxiety, and stress); (2) promoting committed actions of self-care; and (3) building mutual support social networks. Further, participants' satisfaction with the intervention and their perceived barriers to and facilitators of practicing the self-care strategies embedded in WE2CARE will be examined. Methods: A total of 36 live-in caregivers residing in the Greater Toronto Area will be recruited and randomly assigned to either the intervention or waitlist control group. The intervention group will receive a 6-week web-based psychosocial intervention that will be based on Acceptance and Commitment Therapy (ACT). Standardized self-reported surveys will be administered online preintervention, postintervention, and at 6 weeks postintervention to assess mental distress (Depression, Anxiety and Stress Scale), psychological flexibility (Acceptance and Action Questionnaire), mindfulness (Cognitive and Affective Mindfulness Scale -- Revised), and resilience (Multi-System Model of Resilience Inventory). In addition, two focus groups will be held with a subset of participants to explore their feedback on the utility of the WE2CARE program. Results: WE2CARE was funded in January 2019 for a year. The protocol was approved by the research ethics boards of Ryerson University (REB 2019-036) and the University of Toronto (RIS37623) in February and May 2019, respectively. Data collection started upon ethics approval and was completed by May 2020. A total of 29 caregivers completed the study and 20 participated in the focus groups. Data analyses are in progress and results will be published in 2021. Conclusions: WE2CARE could be a promising approach to reducing stress, promoting resilience, and providing a virtual space for peer emotional support and collaborative learning among socially isolated and marginalized women. The results of this pilot study will inform the adaptation of an ACT-based psychological intervention for online delivery and determine its utility in promoting mental health among disadvantaged and vulnerable populations. International Registered Report Identifier (IRRID): DERR1-10.2196/31211 ",
doi="10.2196/31211",
url="https://www.researchprotocols.org/2021/9/e31211",
url="http://www.ncbi.nlm.nih.gov/pubmed/34515642"
}


@Article{info:doi/10.2196/28267,
author="Brehon, Katelyn
and Carriere, Jay
and Churchill, Katie
and Loyola-Sanchez, Adalberto
and O'Connell, Petra
and Papathanassoglou, Elisavet
and MacIsaac, Rob
and Tavakoli, Mahdi
and Ho, Chester
and Pohar Manhas, Kiran",
title="Evaluating Community-Facing Virtual Modalities to Support Complex Neurological Populations During the COVID-19 Pandemic: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2021",
month="Jul",
day="23",
volume="10",
number="7",
pages="e28267",
keywords="telehealth",
keywords="evaluation",
keywords="rehabilitation",
keywords="musculoskeletal",
keywords="neurological",
keywords="COVID-19",
keywords="spinal cord injury",
keywords="advice line",
keywords="webinar",
keywords="artificial intelligence",
keywords="machine learning",
keywords="community engagement",
abstract="Background: The COVID-19 pandemic and concomitant governmental responses have created the need for innovative and collaborative approaches to deliver services, especially for populations that have been inequitably affected. In Alberta, Canada, two novel approaches were created in Spring 2020 to remotely support patients with complex neurological conditions and rehabilitation needs. The first approach is a telehealth service that provides wayfinding and self-management advice to Albertans with physical concerns related to existing neurological or musculoskeletal conditions or post-COVID-19 recovery needs. The second approach is a webinar series aimed at supporting self-management and social connectedness of individuals living with spinal cord injury. Objective: The study aims to evaluate the short- and long-term impacts and sustainability of two virtual modalities (telehealth initiative called Rehabilitation Advice Line [RAL] and webinar series called Alberta Spinal Cord Injury Community Interactive Learning Seminars [AB-SCILS]) aimed at advancing self-management, connectedness, and rehabilitation needs during the COVID-19 pandemic and beyond. Methods: We will use a mixed-methods evaluation approach. Evaluation of the approaches will include one-on-one semistructured interviews and surveys. The evaluation of the telehealth initiative will include secondary data analyses and analysis of call data using artificial intelligence. The evaluation of the webinar series will include analysis of poll questions collected during the webinars and YouTube analytics data. Results: The proposed study describes unique pandemic virtual modalities and our approaches to evaluating them to ensure effectiveness and sustainability. Implementing and evaluating these virtual modalities synchronously allows for the building of knowledge on the complementarity of these methods. At the time of submission, we have completed qualitative and quantitative data collection for the telehealth evaluation. For the webinar series, so far, we have distributed the evaluation survey following three webinars and have conducted five attendee interviews. Conclusions: Understanding the impact and sustainability of the proposed telehealth modalities is important. The results of the evaluation will provide data that can be actioned and serve to improve other telehealth modalities in the future, since health systems need this information to make decisions on resource allocation, especially in an uncertain pandemic climate. Evaluating the RAL and AB-SCILS to ensure their effectiveness demonstrates that Alberta Health Services and the health system care about ensuring the best practice even after a shift to primarily virtual care. International Registered Report Identifier (IRRID): DERR1-10.2196/28267 ",
doi="10.2196/28267",
url="https://www.researchprotocols.org/2021/7/e28267",
url="http://www.ncbi.nlm.nih.gov/pubmed/34101610"
}


@Article{info:doi/10.2196/24642,
author="Enayati, Moein
and Sir, Mustafa
and Zhang, Xingyu
and Parker, J. Sarah
and Duffy, Elizabeth
and Singh, Hardeep
and Mahajan, Prashant
and Pasupathy, S. Kalyan",
title="Monitoring Diagnostic Safety Risks in Emergency Departments: Protocol for a Machine Learning Study",
journal="JMIR Res Protoc",
year="2021",
month="Jun",
day="14",
volume="10",
number="6",
pages="e24642",
keywords="diagnostic error",
keywords="emergency department",
keywords="machine learning",
keywords="electronic health records",
keywords="electronic triggers",
abstract="Background: Diagnostic decision making, especially in emergency departments, is a highly complex cognitive process that involves uncertainty and susceptibility to errors. A combination of factors, including patient factors (eg, history, behaviors, complexity, and comorbidity), provider-care team factors (eg, cognitive load and information gathering and synthesis), and system factors (eg, health information technology, crowding, shift-based work, and interruptions) may contribute to diagnostic errors. Using electronic triggers to identify records of patients with certain patterns of care, such as escalation of care, has been useful to screen for diagnostic errors. Once errors are identified, sophisticated data analytics and machine learning techniques can be applied to existing electronic health record (EHR) data sets to shed light on potential risk factors influencing diagnostic decision making. Objective: This study aims to identify variables associated with diagnostic errors in emergency departments using large-scale EHR data and machine learning techniques. Methods: This study plans to use trigger algorithms within EHR data repositories to generate a large data set of records that are labeled trigger-positive or trigger-negative, depending on whether they meet certain criteria. Samples from both data sets will be validated using medical record reviews, upon which we expect to find a higher number of diagnostic safety events in the trigger-positive subset. Machine learning will be used to evaluate relationships between certain patient factors, provider-care team factors, and system-level risk factors and diagnostic safety signals in the statistically matched groups of trigger-positive and trigger-negative charts. Results: This federally funded study was approved by the institutional review board of 2 academic medical centers with affiliated community hospitals. Trigger queries are being developed at both organizations, and sample cohorts will be labeled using the triggers. Machine learning techniques such as association rule mining, chi-square automated interaction detection, and classification and regression trees will be used to discover important variables that could be incorporated within future clinical decision support systems to help identify and reduce risks that contribute to diagnostic errors. Conclusions: The use of large EHR data sets and machine learning to investigate risk factors (related to the patient, provider-care team, and system-level) in the diagnostic process may help create future mechanisms for monitoring diagnostic safety. International Registered Report Identifier (IRRID): DERR1-10.2196/24642 ",
doi="10.2196/24642",
url="https://www.researchprotocols.org/2021/6/e24642",
url="http://www.ncbi.nlm.nih.gov/pubmed/34125077"
}


@Article{info:doi/10.2196/27526,
author="Lester, Gabriel Ethan
and Hopkins, Whitall Sarah
and Popok, Jean Paula
and Vranceanu, Ana-Maria",
title="Adaptation of a Live Video Mind--Body Program to a Web-Based Platform for English-Speaking Adults With Neurofibromatosis: Protocol for the NF-Web Study",
journal="JMIR Res Protoc",
year="2021",
month="Jun",
day="10",
volume="10",
number="6",
pages="e27526",
keywords="neurofibromatosis",
keywords="quality of life",
keywords="stress management",
keywords="mind--body",
keywords="asynchronous delivery",
keywords="resiliency",
keywords="mobile phone",
abstract="Background: Neurofibromatosis (NF) is a rare genetic condition associated with lower but modifiable quality of life (QoL). Although a virtual live video program (Relaxation Response Resiliency Program for Neurofibromatosis [3RP-NF]; efficacy randomized controlled trial underway) that we created has been made available, ongoing barriers impede some patients from engaging in this intervention. A necessary next step is to develop a stand-alone web-based intervention that reduces barriers to accessing NF-specific psychosocial care. Objective: First, we aim to develop a web-based platform (Neurofibromatosis-Web [NF-Web]) of our mind--body resiliency program (3RP-NF) through qualitative interviews with participants from an adult efficacy randomized controlled trial. Second, we aim to iteratively optimize the feasibility, acceptability, credibility, and satisfaction of the NF-Web platform through open pilot trials with participant exit interviews and explore quantitative outcomes within this sample. Here, we describe the protocol and study design, intervention, and analysis plan. Methods: For aim 1, we will invite completers from our efficacy trial to participate in qualitative interviews. We will use data from these interviews to adapt the content of the live video program for asynchronous delivery and understand how to create a user-friendly format for an engaging web platform. For aim 2, we will enroll eligible participants recruited for the efficacy trial who could not enroll because of treatment barriers. Eligible participants will complete QoL, depression, anxiety, pain, treatment satisfaction, and program credibility measures at baseline and posttest. Inclusion criteria are identical to those for the efficacy trial, including stress and coping difficulties (self-report), no change in antidepressant medication in the past 3 months, no psychotherapy in the past 3 months, no major upcoming surgeries in the next 12 months, English speaking, ability to complete questionnaires on the web and participate in live video interventions, and consent before participation. The primary outcomes are feasibility, treatment satisfaction, and credibility. The secondary outcomes include physical, psychological, social, and environmental QoL; depression; anxiety; pain intensity; and pain interference. We will enroll at least two group cohorts and iteratively refine the program based on participant feedback after each cohort completes the open pilot trial. Results: This trial is ongoing. We have completed the interviews (n=23) and analyzed the data to construct the website. Afterward, we will recruit our cohorts for the trial (approximately n=15/cohort; total=30). Recruitment will end by May 2021, with plans to analyze the data by October 2021. Conclusions: We will develop the first web platform for people with NF with difficulties managing stress and NF symptoms and report on feasibility and preliminary effects in improving QoL and psychosocial functioning. NF-Web has potential to extend the reach of our 3RP-NF intervention by removing barriers to care, including lack of trained providers, scheduling difficulties, and appearance concerns. International Registered Report Identifier (IRRID): DERR1-10.2196/27526 ",
doi="10.2196/27526",
url="https://www.researchprotocols.org/2021/6/e27526",
url="http://www.ncbi.nlm.nih.gov/pubmed/34110294"
}


@Article{info:doi/10.2196/29072,
author="Espinosa-Gonzalez, Belen Ana
and Neves, Luisa Ana
and Fiorentino, Francesca
and Prociuk, Denys
and Husain, Laiba
and Ramtale, Christian Sonny
and Mi, Emma
and Mi, Ella
and Macartney, Jack
and Anand, N. Sneha
and Sherlock, Julian
and Saravanakumar, Kavitha
and Mayer, Erik
and de Lusignan, Simon
and Greenhalgh, Trisha
and Delaney, C. Brendan",
title="Predicting Risk of Hospital Admission in Patients With Suspected COVID-19 in a Community Setting: Protocol for Development and Validation of a Multivariate Risk Prediction Tool",
journal="JMIR Res Protoc",
year="2021",
month="May",
day="25",
volume="10",
number="5",
pages="e29072",
keywords="COVID-19 severity",
keywords="risk prediction tool",
keywords="early warning score",
keywords="hospital admission",
keywords="primary care",
keywords="electronic health records",
abstract="Background: During the pandemic, remote consultations have become the norm for assessing patients with signs and symptoms of COVID-19 to decrease the risk of transmission. This has intensified the clinical uncertainty already experienced by primary care clinicians when assessing patients with suspected COVID-19 and has prompted the use of risk prediction scores, such as the National Early Warning Score (NEWS2), to assess severity and guide treatment. However, the risk prediction tools available have not been validated in a community setting and are not designed to capture the idiosyncrasies of COVID-19 infection. Objective: The objective of this study is to produce a multivariate risk prediction tool, RECAP-V1 (Remote COVID-19 Assessment in Primary Care), to support primary care clinicians in the identification of those patients with COVID-19 that are at higher risk of deterioration and facilitate the early escalation of their treatment with the aim of improving patient outcomes. Methods: The study follows a prospective cohort observational design, whereby patients presenting in primary care with signs and symptoms suggestive of COVID-19 will be followed and their data linked to hospital outcomes (hospital admission and death). Data collection will be carried out by primary care clinicians in four arms: North West London Clinical Commissioning Groups (NWL CCGs), Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), Covid Clinical Assessment Service (CCAS), and South East London CCGs (Doctaly platform). The study involves the use of an electronic template that incorporates a list of items (known as RECAP-V0) thought to be associated with disease outcome according to previous qualitative work. Data collected will be linked to patient outcomes in highly secure environments. We will then use multivariate logistic regression analyses for model development and validation. Results: Recruitment of participants started in October 2020. Initially, only the NWL CCGs and RCGP RSC arms were active. As of March 24, 2021, we have recruited a combined sample of 3827 participants in these two arms. CCAS and Doctaly joined the study in February 2021, with CCAS starting the recruitment process on March 15, 2021. The first part of the analysis (RECAP-V1 model development) is planned to start in April 2021 using the first half of the NWL CCGs and RCGP RSC combined data set. Posteriorly, the model will be validated with the rest of the NWL CCGs and RCGP RSC data as well as the CCAS and Doctaly data sets. The study was approved by the Research Ethics Committee on May 27, 2020 (Integrated Research Application System number: 283024, Research Ethics Committee reference number: 20/NW/0266) and badged as National Institute of Health Research Urgent Public Health Study on October 14, 2020. Conclusions: We believe the validated RECAP-V1 early warning score will be a valuable tool for the assessment of severity in patients with suspected COVID-19 in the community, either in face-to-face or remote consultations, and will facilitate the timely escalation of treatment with the potential to improve patient outcomes. Trial Registration: ISRCTN registry ISRCTN13953727; https://www.isrctn.com/ISRCTN13953727 International Registered Report Identifier (IRRID): DERR1-10.2196/29072 ",
doi="10.2196/29072",
url="https://www.researchprotocols.org/2021/5/e29072",
url="http://www.ncbi.nlm.nih.gov/pubmed/33939619"
}


@Article{info:doi/10.2196/29152,
author="Wirtz, L. Andrea
and Cooney, E. Erin
and Stevenson, Megan
and Radix, Asa
and Poteat, Tonia
and Wawrzyniak, J. Andrew
and Cannon, M. Christopher
and Schneider, S. Jason
and Haw, Sonya J.
and Case, James
and Althoff, N. Keri
and Humes, Elizabeth
and Mayer, H. Kenneth
and Beyrer, Chris
and Rodriguez, E. Allan
and Reisner, L. Sari
and ",
title="Digital Epidemiologic Research on Multilevel Risks for HIV Acquisition and Other Health Outcomes Among Transgender Women in Eastern and Southern United States: Protocol for an Online Cohort",
journal="JMIR Res Protoc",
year="2021",
month="Apr",
day="26",
volume="10",
number="4",
pages="e29152",
keywords="transgender persons",
keywords="United States",
keywords="cohort studies",
keywords="digital research",
keywords="HIV infection",
keywords="HIV testing",
keywords="public health",
keywords="online health",
keywords="transgender",
keywords="HIV",
abstract="Background: The HIV epidemic disproportionately impacts transgender women in the United States. Cohort studies identify unique risks for affected populations, but use of facility-based methods may bias findings towards individuals living in research catchment areas, more engaged in health services, or, in the case of transgender populations, those who are open about their transgender identity. Digital clinical trials and other online research methods are increasingly common, providing opportunity to reach those not commonly engaged in research. Simultaneously, there is a need to understand potential biases associated with digital research, how these methods perform, and whether they are accepted across populations. Objective: This study aims to assess the feasibility of developing and implementing an online cohort of transgender women to assess risks for HIV acquisition and other health experiences. Further, this study aims to evaluate how an online cohort compares to a site-based, technology-enhanced cohort for epidemiologic research. The overarching goal is to estimate incidence of HIV and other health outcomes among transgender women in eastern and southern United States. Methods: This substudy is part of a larger multisite prospective cohort (LITE) conducted among transgender women, which also includes a site-based, technology-enhanced cohort in 6 eastern and southern US cities. The online cohort was launched to enroll and follow participants across 72 cities in the same region and with similar demographic characteristics as the site-based cohort. Participants are followed for 24 months. Adult transgender women are recruited via convenience sampling (eg, peer referrals, social media, and dating apps). Participants reporting negative or unknown HIV status are enrolled in a baseline study visit, complete a sociobehavioral survey, and provide oral fluid specimens to test for HIV. Participants not living with HIV (lab-confirmed) at baseline are offered enrollment into the cohort; follow-up assessments occur every 6 months. Results: Enrollment into the online cohort launched in January 2019. Active recruitment stopped in May 2019, and enrollment officially closed in August 2020. A total of 580 participants enrolled into and are followed in the cohort. A recruitment-enrollment cascade was observed across screening, consent, and completion of study activities. Implementation experiences with HIV test kits highlight the need for heavy staff engagement to support participant engagement, visit completion, and retention, even with automated digital procedures. Conclusions: This study is responsive to increasing research interest in digital observational and intervention research, particularly for populations who are most affected by the HIV epidemic and for those who may otherwise not participate in person. The progression across stages of the recruitment-enrollment cascade provides useful insight for implementation of cohort studies in the online environment. International Registered Report Identifier (IRRID): DERR1-10.2196/29152 ",
doi="10.2196/29152",
url="https://www.researchprotocols.org/2021/4/e29152",
url="http://www.ncbi.nlm.nih.gov/pubmed/33900202"
}


@Article{info:doi/10.2196/24818,
author="Luo, Lingzi
and King, A. Allison
and Carroll, Yvonne
and Baumann, A. Ana
and Brambilla, Donald
and Carpenter, R. Christopher
and Colla, Joseph
and Gibson, W. Robert
and Gollan, Siera
and Hall, Greg
and Klesges, Lisa
and Kutlar, Abdullah
and Lyon, Matthew
and Melvin, L. Cathy
and Norell, Sarah
and Mueller, Martina
and Potter, B. Michael
and Richesson, Rachel
and Richardson, D. Lynne
and Ryan, Gery
and Siewny, Lauren
and Treadwell, Marsha
and Zun, Leslie
and Armstrong-Brown, Janelle
and Cox, Lisa
and Tanabe, Paula",
title="Electronic Health Record--Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study",
journal="JMIR Res Protoc",
year="2021",
month="Apr",
day="16",
volume="10",
number="4",
pages="e24818",
keywords="sickle cell disease",
keywords="RE-AIM",
keywords="emergency department care",
keywords="pain treatment",
keywords="digital medicine",
keywords="health innovation",
keywords="implementation science",
keywords="patient portal",
keywords="electronic health record",
abstract="Background: Individuals living with sickle cell disease often require aggressive treatment of pain associated with vaso-occlusive episodes in the emergency department. Frequently, pain relief is poor. The 2014 National Heart, Lung, and Blood Institute evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of vaso-occlusive episodes. Objective: This study will implement an electronic health record--embedded individualized pain plan with provider and patient access in the emergency departments of 8 US academic centers to improve pain treatment for adult patients with sickle cell disease. This study will assess the overall effects of electronic health record--embedded individualized pain plans on improving patient and provider outcomes associated with pain treatment in the emergency department setting and explore barriers and facilitators to the implementation process. Methods: A preimplementation and postimplementation study is being conducted by all 8 sites that are members of the National Heart, Lung, and Blood Institute--funded Sickle Cell Disease Implementation Consortium. Adults with sickle cell disease aged 18 to 45 years who had a visit to a participating emergency department for vaso-occlusive episodes within 90 days prior to enrollment will be eligible for inclusion. Patients will be enrolled in the clinic or remotely. The target analytical sample size of this study is 160 patient participants (20 per site) who have had an emergency department visit for vaso-occlusive episode treatment at participating emergency departments during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The electronic health record--embedded individualized pain plans will be written by the patient's sickle cell disease provider, and sites will work with the local informatics team to identify the best method to build the electronic health record--embedded individualized pain plan with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Technology Acceptance Model 2 and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an emergency department vaso-occlusive episode visit, and selected qualitative interviews within 2 weeks of an emergency department visit will be performed to assess the primary outcome, patient-perceived quality of emergency department pain treatment, and additional implementation and intervention outcomes. Electronic health record data will be used to analyze individualized pain plan adherence and additional secondary outcomes, such as hospital admission and readmission rates. Results: The study is currently enrolling study participants. The active implementation period is 18 months. Conclusions: This study proposes a structured, framework-informed approach to implement electronic health record--embedded individualized pain plans with both patient and provider access in routine emergency department practice. The results of the study will inform the implementation of electronic health record--embedded individualized pain plans at a larger scale outside of Sickle Cell Disease Implementation Consortium centers. Trial Registration: ClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528. International Registered Report Identifier (IRRID): DERR1-10.2196/24818 ",
doi="10.2196/24818",
url="https://www.researchprotocols.org/2021/4/e24818",
url="http://www.ncbi.nlm.nih.gov/pubmed/33861209"
}


@Article{info:doi/10.2196/25699,
author="Gamble, Abigail
and Beech, M. Bettina
and Wade, C. Breanna
and Sutton, D. Victor
and Lim, Crystal
and Sandridge, Shanda
and Welsch, A. Michael",
title="Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth: Protocol for a Pilot Trial",
journal="JMIR Res Protoc",
year="2021",
month="Mar",
day="31",
volume="10",
number="3",
pages="e25699",
keywords="prediabetic state",
keywords="child obesity",
keywords="telehealth",
keywords="obesity management",
keywords="behavioral science",
keywords="implementation science",
keywords="Jackson Heart Study",
keywords="Centers for Disease Control and Prevention",
keywords="preventive medicine",
keywords="mobile phone",
abstract="Background: In 1999, type 2 diabetes mellitus (T2DM) was identified as an emerging epidemic in youth, and racial and ethnic minority youth were identified with high risk. Two decades later, no gold standard T2DM prevention intervention has been established for this population. Objective: This study tests the efficacy of a telehealth diabetes prevention intervention for African American (AA) families with children with risk for T2DM. Concurrently, investigators aim to evaluate an implementation strategy for the uptake of the intervention by the University of Mississippi Medical Center's (UMMC) pediatric weight management clinic. Methods: This single-arm trial will enroll 20 parents with overweight or obesity of children (8-11 years) with overweight or obesity, both of whom are at risk for T2DM. Parents will meet in small groups (5 parents per group) weekly for 11 weeks and then monthly for 4 monthly maintenance sessions via videoconference using Wi-Fi--enabled iPads with cellular connectivity. The intervention will be adapted from the National Diabetes Prevention Program and Power to Prevent, a diabetes prevention program tailored for AA families. The same lifestyle intervention facilitated by a racially concordant lifestyle coach trained in the Diabetes Prevention Program will be delivered to all groups (n=4). Participants will be recruited in-person during patient encounters at the UMMC's pediatric weight management clinic. Sessions will consist of dietary and physical activity behavior change strategies facilitated using problem-solving and goal-setting skills. The implementation strategy has 2 targets: the pediatric weight management clinic site and clinical team and parents of children at risk for T2DM engaged in intensive obesity treatment to prevent T2DM. The multifaceted implementation protocol includes 4 discrete strategies: creating a new clinical team, changing the service site, intervening with families, and promoting organizational readiness for change. Results: Recruitment and enrollment began in December 2020, and the intervention is scheduled to be delivered to the first cohort of parents in March 2021. The results are expected to be submitted for publication beginning in November 2021 through 2022. The primary outcome measure for the pilot trial will include changes from baseline to 12 and 30 weeks in the child BMI z score and parent BMI. The implementation evaluation will include multiple measures of feasibility, acceptability, appropriateness, fidelity, and efficacy. This protocol was approved by the UMMC's Institutional Review Board (\#2020V0249). Conclusions: The proposed intervention approach is supported by the scientific literature and is scalable given the current and future health care subsidies for telehealth. Findings from this pilot trial will begin to address critical barriers to defining a gold standard lifestyle intervention for AA families with children at risk for T2DM. If effective, the intervention could be feasibly disseminated to treat obesity and prevent T2DM in high-risk AA pediatric populations. International Registered Report Identifier (IRRID): PRR1-10.2196/25699 ",
doi="10.2196/25699",
url="https://www.researchprotocols.org/2021/3/e25699",
url="http://www.ncbi.nlm.nih.gov/pubmed/33787504"
}


@Article{info:doi/10.2196/24414,
author="Terra, Lara
and Hooning, J. Maartje
and Heemskerk-Gerritsen, M. Bernadette A.
and van Beurden, Marc
and Roeters van Lennep, E. Jeanine
and van Doorn, C. Helena
and de Hullu, A. Joanne
and Mom, Constantijne
and van Dorst, L. Eleonora B.
and Mourits, E. Marian J.
and Slangen, M. Brigitte F.
and Gaarenstroom, N. Katja
and Zillikens, Carola M.
and Leiner, Tim
and van der Kolk, Lizet
and Collee, Margriet
and Wevers, Marijke
and Ausems, M. Margreet G. E.
and van Engelen, Klaartje
and Berger, PV Lieke
and van Asperen, J. Christi
and Gomez-Garcia, B. Encarna
and van de Beek, Irma
and Rookus, A. Matti
and Hauptmann, Michael
and Bleiker, M. Eveline
and Schagen, B. Sanne
and Aaronson, K. Neil
and Maas, M. Angela H. E.
and van Leeuwen, E. Flora",
title="Long-Term Morbidity and Health After Early Menopause Due to Oophorectomy in Women at Increased Risk of Ovarian Cancer: Protocol for a Nationwide Cross-Sectional Study With Prospective Follow-Up (HARMOny Study)",
journal="JMIR Res Protoc",
year="2021",
month="Jan",
day="22",
volume="10",
number="1",
pages="e24414",
keywords="risk-reducing salpingo-oophorectomy",
keywords="BRCA1/2",
keywords="cardiovascular disease",
keywords="osteoporosis",
keywords="cognition",
keywords="health-related quality of life",
abstract="Background: BRCA1/2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) at 35 to 45 years of age. RRSO substantially decreases ovarian cancer risk, but at the cost of immediate menopause. Knowledge about the potential adverse effects of premenopausal RRSO, such as increased risk of cardiovascular disease, osteoporosis, cognitive dysfunction, and reduced health-related quality of life (HRQoL), is limited. Objective: The aim of this study is to assess the long-term health effects of premenopausal RRSO on cardiovascular disease, bone health, cognitive functioning, urological complaints, sexual functioning, and HRQoL in women with high familial risk of breast or ovarian cancer. Methods: We will conduct a multicenter cross-sectional study with prospective follow-up, nested in a nationwide cohort of women at high familial risk of breast or ovarian cancer. A total of 500 women who have undergone RRSO before 45 years of age, with a follow-up period of at least 10 years, will be compared with 250 women (frequency matched on current age) who have not undergone RRSO or who have undergone RRSO at over 55 years of age. Participants will complete an online questionnaire on lifestyle, medical history, cardiovascular risk factors, osteoporosis, cognitive function, urological complaints, and HRQoL. A full cardiovascular assessment and assessment of bone mineral density will be performed. Blood samples will be obtained for marker analysis. Cognitive functioning will be assessed objectively with an online neuropsychological test battery. Results: This study was approved by the institutional review board in July 2018. In February 2019, we included our first participant. As of November 2020, we had enrolled 364 participants in our study. Conclusions: Knowledge from this study will contribute to counseling women with a high familial risk of breast/ovarian cancer about the long-term health effects of premenopausal RRSO. The results can also be used to offer health recommendations after RRSO. Trial Registration: ClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793. International Registered Report Identifier (IRRID): DERR1-10.2196/24414 ",
doi="10.2196/24414",
url="http://www.researchprotocols.org/2021/1/e24414/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33480862"
}


@Article{info:doi/10.2196/20184,
author="Zolnoori, Maryam
and McDonald, V. Margaret
and Barr{\'o}n, Yolanda
and Cato, Kenrick
and Sockolow, Paulina
and Sridharan, Sridevi
and Onorato, Nicole
and Bowles, Kathryn
and Topaz, Maxim",
title="Improving Patient Prioritization During Hospital-Homecare Transition: Protocol for a Mixed Methods Study of a Clinical Decision Support Tool Implementation",
journal="JMIR Res Protoc",
year="2021",
month="Jan",
day="22",
volume="10",
number="1",
pages="e20184",
keywords="clinical decision support system",
keywords="homecare agencies",
keywords="rehospitalization",
keywords="RE-AIM framework",
keywords="PREVENT",
keywords="effective implementation",
abstract="Background: Homecare settings across the United States provide care to more than 5 million patients every year. About one in five homecare patients are rehospitalized during the homecare episode, with up to two-thirds of these rehospitalizations occurring within the first 2 weeks of services. Timely allocation of homecare services might prevent a significant portion of these rehospitalizations. The first homecare nursing visit is one of the most critical steps of the homecare episode. This visit includes an assessment of the patient's capacity for self-care, medication reconciliation, an examination of the home environment, and a discussion regarding whether a caregiver is present. Hence, appropriate timing of the first visit is crucial, especially for patients with urgent health care needs. However, nurses often have limited and inaccurate information about incoming patients, and patient priority decisions vary significantly between nurses. We developed an innovative decision support tool called Priority for the First Nursing Visit Tool (PREVENT) to assist nurses in prioritizing patients in need of immediate first homecare nursing visits. Objective: This study aims to evaluate the effectiveness of the PREVENT tool on process and patient outcomes and to examine the reach, adoption, and implementation of PREVENT. Methods: Employing a pre-post design, survival analysis, and logistic regression with propensity score matching analysis, we will test the following hypotheses: compared with not using the tool in the preintervention phase, when homecare clinicians use the PREVENT tool, high-risk patients in the intervention phase will (1) receive more timely first homecare visits and (2) have decreased incidence of rehospitalization and have decreased emergency department use within 60 days. Reach, adoption, and implementation will be assessed using mixed methods including homecare admission staff interviews, think-aloud observations, and analysis of staffing and other relevant data. Results: The study research protocol was approved by the institutional review board in October 2019. PREVENT is currently being integrated into the electronic health records at the participating study sites. Data collection is planned to start in early 2021. Conclusions: Mixed methods will enable us to gain an in-depth understanding of the complex socio-technological aspects of the hospital to homecare transition. The results have the potential to (1) influence the standardization and individualization of nurse decision making through the use of cutting-edge technology and (2) improve patient outcomes in the understudied homecare setting. Trial Registration: ClinicalTrials.gov NCT04136951; https://clinicaltrials.gov/ct2/show/NCT04136951 International Registered Report Identifier (IRRID): PRR1-10.2196/20184 ",
doi="10.2196/20184",
url="https://www.researchprotocols.org/2021/1/e20184",
url="http://www.ncbi.nlm.nih.gov/pubmed/33480855"
}


@Article{info:doi/10.2196/20819,
author="Daud{\'e}n Roquet, Claudia
and Sas, Corina",
title="A Mindfulness-Based Brain-Computer Interface to Augment Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design",
journal="JMIR Res Protoc",
year="2021",
month="Jan",
day="18",
volume="10",
number="1",
pages="e20819",
keywords="brain-computer interface",
keywords="mental well-being",
keywords="depression",
keywords="mindfulness",
keywords="mandala coloring",
abstract="Background: The regular practice of mindfulness has been shown to provide benefits for mental well-being and prevent depression relapse. Technology-mediated interventions can facilitate the uptake and sustained practice of mindfulness, yet the evaluation of interactive systems, such as brain-computer interfaces, has been little explored. Objective: The objective of this paper is to present an interactive mindfulness-based technology to improve mental well-being in people who have experienced depression. The system, Anima, is a brain-computer interface that augments mandala coloring by providing a generative color palette based on the unfolding mindfulness states during the practice. In addition, this paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness. Methods: Adult participants who have experienced depression in the past, have finished treatment within the last year, and can provide informed consent will be able to be recruited. The Anima system, consisting of 2 tablets and a nonintrusive mental activity headband, will be delivered to participants to use during the study. Measures include state and trait mindfulness, depression symptoms, mental well-being, and user experience, and these measures will be taken throughout the baseline, intervention, and monitoring phases. The data collection will take place in the form of a questionnaire before and after each mandala-coloring session and a semistructured interview every 2 weeks. Trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology. Results: Study results will offer new insights into the deployment and evaluation of novel interactive brain-computer interfaces for mindfulness training in the context of mental health. Moreover, findings will validate the effectiveness of this training protocol to improve the mental well-being of people who have had depression. Participants will be recruited locally through the National Health Service. Conclusions: Evidence will assist in the design and evaluation of brain-computer interfaces and mindfulness technologies for mental well-being and the necessary services to support people who have experienced depression. International Registered Report Identifier (IRRID): PRR1-10.2196/20819 ",
doi="10.2196/20819",
url="http://www.researchprotocols.org/2021/1/e20819/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33459604"
}


@Article{info:doi/10.2196/21840,
author="Bruno, Elisa
and Biondi, Andrea
and B{\"o}ttcher, Sebastian
and V{\'e}rtes, Gergely
and Dobson, Richard
and Folarin, Amos
and Ranjan, Yatharth
and Rashid, Zulqarnain
and Manyakov, Nikolay
and Rintala, Aki
and Myin-Germeys, Inez
and Simblett, Sara
and Wykes, Til
and Stoneman, Amanda
and Little, Ann
and Thorpe, Sarah
and Lees, Simon
and Schulze-Bonhage, Andreas
and Richardson, Mark",
title="Remote Assessment of Disease and Relapse in Epilepsy: Protocol for a Multicenter Prospective Cohort Study",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="16",
volume="9",
number="12",
pages="e21840",
keywords="epilepsy",
keywords="seizures",
keywords="telemedicine",
keywords="medical device",
keywords="mobile phone",
abstract="Background: In recent years, a growing body of literature has highlighted the role of wearable and mobile remote measurement technology (RMT) applied to seizure detection in hospital settings, whereas more limited evidence has been produced in the community setting. In clinical practice, seizure assessment typically relies on self-report, which is known to be highly unreliable. Moreover, most people with epilepsy self-identify factors that lead to increased seizure likelihood, including mood, behavior, sleep pattern, and cognitive alterations, all of which are amenable to measurement via multiparametric RMT. Objective: The primary aim of this multicenter prospective cohort study is to assess the usability, feasibility, and acceptability of RMT in the community setting. In addition, this study aims to determine whether multiparametric RMT collected in populations with epilepsy can prospectively estimate variations in seizure occurrence and other outcomes, including seizure frequency, quality of life, and comorbidities. Methods: People with a diagnosis of pharmacoresistant epilepsy will be recruited in London, United Kingdom, and Freiburg, Germany. Participants will be asked to wear a wrist-worn device and download ad hoc apps developed on their smartphones. The apps will be used to collect data related to sleep, physical activity, stress, mood, social interaction, speech patterns, and cognitive function, both passively from existing smartphone sensors (passive remote measurement technology [pRMT]) and actively via questionnaires, tasks, and assessments (active remote measurement technology [aRMT]). Data will be collected continuously for 6 months and streamed to the Remote Assessment of Disease and Relapse-base (RADAR-base) server. Results: The RADAR Central Nervous System project received funding in 2015 from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement No. 115902. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and European Federation of Pharmaceutical Industries and Associations. Ethical approval was obtained in London from the Bromley Research Ethics Committee (research ethics committee reference: 19/LO/1884) in January 2020. The first participant was enrolled on September 30, 2020. Data will be collected until September 30, 2021. The results are expected to be published at the beginning of 2022. Conclusions: RADAR Epilepsy aims at developing a framework of continuous data collection intended to identify ictal and preictal states through the use of aRMT and pRMT in the real-life environment. The study was specifically designed to evaluate the clinical usefulness of the data collected via new technologies and compliance, technology acceptability, and usability for patients. These are key aspects to successful adoption and implementation of RMT as a new way to measure and manage long-term disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/21840 ",
doi="10.2196/21840",
url="http://www.researchprotocols.org/2020/12/e21840/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33325373"
}


@Article{info:doi/10.2196/21592,
author="Kohli, Maulika
and Pasipanodya, C. Elizabeth
and Montoya, L. Jessica
and Marquine, Maria
and Hoenigl, Martin
and Serrano, Vanessa
and Cushman, Clint
and Garcia, Rogelio
and Kua, John
and Gant, Verna
and Rojas, Sarah
and Moore, J. David",
title="A Culturally Adapted SMS Text Messaging Intervention to Promote Antiretroviral Therapy Adherence Among African Americans: Protocol for a Single-Arm Trial",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="10",
volume="9",
number="12",
pages="e21592",
keywords="medication adherence",
keywords="behavior modification",
keywords="short message service",
keywords="mHealth",
keywords="HIV/AIDS",
abstract="Background: African Americans are disproportionally affected by HIV and have poorer rates of antiretroviral therapy (ART) adherence compared to other racial or ethnic groups in the United States. Factors associated with poor HIV disease outcomes are commonly associated with sociostructural barriers that prevent engagement with and retention in HIV care. SMS text messaging interventions to promote ART adherence among predominantly non-Hispanic White persons with HIV (PWH) have been shown to be efficacious; however, limited research has been devoted to culturally tailoring interventions for underrepresented racial/ethnic groups. Considering African Americans show poorer engagement along the HIV care continuum, we developed an individualized and culturally tailored two-way SMS text messaging intervention to improve ART adherence and associated virologic suppression among African American PWH. Objective: In this paper we describe the protocol of a culturally tailored individualized Texting for Adherence Building (iTAB) intervention in a 24- to 48-week, single-arm study. Methods: We developed a culturally tailored iTAB intervention, which we are implementing in a 24- to 48-week, single-arm study. Participants were recruited from the Family Health Centers of San Diego (FHCSD), a federally qualified health center. Patient inclusion criteria were (1) receiving care at the FHCSD, (2) living with HIV, (3) self-identification as Black, African American, or of African ancestry, (4) English speaking, (5) age 18 or older, (6) currently on ART, and (7) able to provide informed consent. Study enrollment began in November 2017 and closed in July 2019. A total of 90 participants from the FHCSD enrolled in the iTAB intervention, and we anticipate completing data collection in July 2020. Participants were assisted in individualizing and customizing their SMS text message preferences at the baseline study visit. Self-assessment measures are collected at baseline, interim, and final study visits. Problems related to sending/receiving SMS text messages and barriers to ART adherence are assessed at each interim study visit. The FHCSD staff monitors and tracks participants' daily SMS text message responses to ART adherence reminders using a clinical dashboard. Results: We hypothesize that the proportion of individuals achieving HIV virologic suppression (viral load <40 copies/mL) will be greater at the end of the intervention period compared to the proportion prior to study implementation. Additionally, we anticipate that rates of virologic suppression at the end of the intervention among participants receiving iTAB will be comparable to those among the general FHCSD non-African American population who did not receive iTAB. Finally, we anticipate a high response rate to iTAB SMS text messages as well as positive participant feedback at the end of the intervention with regard to the acceptability of, satisfaction with, and perceived efficacy of iTAB. Conclusions: The iTAB intervention is a novel individualized two-way SMS text messaging intervention that has been culturally tailored for use among African Americans with HIV. We anticipate that iTAB will demonstrate efficacy in future randomized control trials and will be supportive of medication adherence among other populations facing health disparities. International Registered Report Identifier (IRRID): DERR1-10.2196/21592 ",
doi="10.2196/21592",
url="https://www.researchprotocols.org/2020/12/e21592",
url="http://www.ncbi.nlm.nih.gov/pubmed/33300885"
}


@Article{info:doi/10.2196/18004,
author="Dodds, Lynn Robin",
title="Helping Optimize Language Acquisition (HOLA) Online Parent Training Modules for Latinx Parents of Toddlers at Risk for ASD: Protocol for a Pilot Funded by the Organization for Autism Research",
journal="JMIR Res Protoc",
year="2020",
month="Dec",
day="10",
volume="9",
number="12",
pages="e18004",
keywords="autism spectrum disorders",
keywords="cultural diversity",
keywords="parent training",
keywords="pivotal response treatment",
keywords="health disparities",
keywords="online training",
keywords="autism",
keywords="intervention delay",
keywords="online learning",
keywords="pediatrics",
abstract="Background: Culturally competent parent training in evidence-based intervention for autism spectrum disorder (ASD) can provide young Latinx children from underserved communities with early interventional support while they wait for professional services, thus reducing the impact of intervention delays. Providing parents with brief bilingual training in Pivotal Response Treatment (PRT) is a strategy that can overcome these barriers and is inexpensive to disseminate. Brief PRT training has been shown to significantly improve joint attention, expressive language, responsivity, and adaptive skills in young children with ASD. However, it is unknown whether an interactive, culturally competent online parent training in PRT is effective in a Latinx population. Objective: To this end, we will recruit 24 children (16-36 months old) at risk for ASD and their parent(s) from East and South Los Angeles and provide them with a series of 6 online learning modules in their choice of Spanish or English. Methods: This pilot study will utilize a single-group, pilot, pre-post design with follow-up assessments 6 weeks later. Linear mixed-effects model analysis will be used to explore most parent-reported and coded outcomes. Results: Brief online parent training in evidence-based treatments has the capacity to increase access to culturally competent early communication interventions for young children at risk for ASD. Conclusions: The results of this trial may have particular salience in additional underresourced communities where children have limited access to interventions prior to entering school. International Registered Report Identifier (IRRID): PRR1-10.2196/18004 ",
doi="10.2196/18004",
url="http://www.researchprotocols.org/2020/12/e18004/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33300494"
}


@Article{info:doi/10.2196/20072,
author="Lorenzoni, Giulia
and Azzolina, Danila
and Fraccaro, Chiara
and Di Liberti, Alessandro
and D'Onofrio, Augusto
and Cavalli, Chiara
and Fabris, Tommaso
and D'Amico, Gianpiero
and Cibin, Giorgia
and Nai Fovino, Luca
and Ocagli, Honoria
and Gerosa, Gino
and Tarantini, Giuseppe
and Gregori, Dario",
title="Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study",
journal="JMIR Res Protoc",
year="2020",
month="Nov",
day="12",
volume="9",
number="11",
pages="e20072",
keywords="surgical aortic valve replacement",
keywords="transcatheter aortic valve replacement",
keywords="physical function",
keywords="wearable devices",
abstract="Background: In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. Objective: This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. Methods: This is a prospective observational study. The enrollment will be conducted 1 month before patients' SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin v{\'i}voactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. Results: The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. Conclusions: The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. Trial Registration: Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y International Registered Report Identifier (IRRID): DERR1-10.2196/20072 ",
doi="10.2196/20072",
url="https://www.researchprotocols.org/2020/11/e20072",
url="http://www.ncbi.nlm.nih.gov/pubmed/33180023"
}


@Article{info:doi/10.2196/20547,
author="Craig, L. Shelley
and Eaton, D. Andrew
and Pascoe, Rachael
and Egag, Egag
and McInroy, B. Lauren
and Fang, Lin
and Austin, Ashley
and Dentato, P. Michael",
title="QueerVIEW: Protocol for a Technology-Mediated Qualitative Photo Elicitation Study With Sexual and Gender Minority Youth in Ontario, Canada",
journal="JMIR Res Protoc",
year="2020",
month="Nov",
day="5",
volume="9",
number="11",
pages="e20547",
keywords="lesbian",
keywords="gay",
keywords="bisexual",
keywords="transgender",
keywords="queer",
keywords="youth",
keywords="photo elicitation",
keywords="photo voice",
keywords="grounded theory",
keywords="online research",
keywords="Canada",
abstract="Background: The experiences of resilience and intersectionality in the lives of contemporary sexual and gender minority youth (SGMY) are important to explore. SGMY face unique experiences of discrimination in both online and offline environments, yet simultaneously build community and seek support in innovative ways. SGMY who identify as transgender, trans, or gender nonconforming and have experiences with child welfare, homelessness, or immigration have been particularly understudied. A qualitative exploration that leverages technology may derive new understanding of the negotiations of risk, resilience, and identity intersections that impact the well-being of vulnerable SGMY. Objective: The objectives of the QueerVIEW study were to (1) enhance understanding of SGMY identities, both online and offline, (2) identify experiences of intersectionality among culturally, regionally, and racially diverse SGMY in Ontario, Canada, (3)?explore online and offline sources of resilience for SGMY, and (4) develop and apply a virtual photo elicitation methodological approach. Methods: This is the first study to pilot a completely virtual approach to a photo elicitation investigation with youth, including data collection, recruitment, interviewing, and analysis. Recruited through social media, SGMY completed a brief screening survey, submitted 10 to 15 digital photos, and then participated in an individual semistructured interview that focused on their photos and related life experiences. Online data collection methods were employed through encrypted online file transfer and secure online interviews. Data is being analyzed using a constructivist grounded theory approach, with six coders participating in structured online meetings that triangulated photo, video, and textual data. Results: Data collection with 30 participants has been completed and analyses are underway. SGMY expressed appreciation for the photo elicitation and online design of the study and many reported experiencing an emotional catharsis from participating in this process. It is anticipated that results will form a model of how participants work toward integrating their online and offline experiences and identities into developing a sense of themselves as resilient. Conclusions: This protocol presents an innovative, technology-enabled qualitative study that completely digitized a popular arts-based methodology---photo elicitation---that has potential utility for contemporary research with marginalized populations. The research design and triangulated analyses can generate more nuanced conceptualizations of SGMY identities and resilience than more traditional approaches. Considerations for conducting online research may be useful for other qualitative research. International Registered Report Identifier (IRRID): DERR1-10.2196/20547 ",
doi="10.2196/20547",
url="https://www.researchprotocols.org/2020/11/e20547",
url="http://www.ncbi.nlm.nih.gov/pubmed/33151153"
}


@Article{info:doi/10.2196/18648,
author="L{\"o}ffler, Christin
and Kr{\"u}ger, Antje
and Daubmann, Anne
and Iwen, Julia
and Biedermann, Marc
and Schulz, Maike
and Wegscheider, Karl
and Altiner, Attila
and Feldmeier, Gregor
and Wollny, Anja",
title="Optimizing Antibiotic Prescribing for Acute Respiratory Tract Infection in German Primary Care: Study Protocol for Evaluation of the RESIST Program",
journal="JMIR Res Protoc",
year="2020",
month="Sep",
day="30",
volume="9",
number="9",
pages="e18648",
keywords="antibacterial agents",
keywords="respiratory tract infection",
keywords="upper respiratory tract infection",
keywords="lower respiratory tract infection",
keywords="primary care",
keywords="primary health care",
keywords="physician-patient relation",
keywords="shared decision making",
keywords="antibiotic resistance",
abstract="Background: The emergence and increased spread of microbial resistance is a major challenge to all health care systems worldwide. In primary care, acute respiratory tract infection (ARTI) is the health condition most strongly related to antibiotic overuse. Objective: The RESIST program aims at optimizing antibiotic prescribing for ARTI in German primary care. By completing a problem-orientated online training course, physicians are motivated and empowered to utilize patient-centered doctor-patient communication strategies, including shared decision making, in the treatment of patients with ARTI. Methods: RESIST will be evaluated in the form of a nonrandomized controlled trial. Approximately 3000 physicians of 8 (out of 16) German federal states can participate in the program. Patient and physician data are retrieved from routine health care data. Physicians not participating in the program serve as controls, either among the 8 participating regional Associations of Statutory Health Insurance Physicians (control group 1) or among the remaining associations not participating in RESIST (control group 2). Antibiotic prescription rates before the intervention (T0: 2016, 1st and 2nd quarters of 2017) and after the intervention (T1: 3rd quarter of 2017 until 1st quarter of 2019) will be compared. The primary outcome measure is the overall antibiotic prescription rate for all patients insured with German statutory health insurance before and after provision of the online course. The secondary outcome is the antibiotic prescription rate for coded ARTI before and after the intervention. Results: RESIST is publicly funded by the Innovations funds of the Federal Joint Committee in Germany and was approved in December 2016. Recruitment of physicians is now completed, and a total of 2460 physicians participated in the intervention. Data analysis started in February 2020. Conclusions: With approximately 3000 physicians participating in the program, RESIST is among the largest real-world interventions aiming at reducing inadequate antibiotic prescribing for ARTI in primary care. Long-term follow up of up to 21 months will allow for investigating the sustainability of the intervention. Trial Registration: ISRCTN Registry ISRCTN13934505; http://www.isrctn.com/ISRCTN13934505 International Registered Report Identifier (IRRID): RR1-10.2196/18648 ",
doi="10.2196/18648",
url="http://www.researchprotocols.org/2020/9/e18648/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32996888"
}


@Article{info:doi/10.2196/16089,
author="Piano, Marianne
and Nilforooshan, Ramin
and Evans, Simon",
title="Binocular Vision, Visual Function, and Pupil Dynamics in People Living With Dementia and Their Relation to the Rate of Cognitive Decline and Structural Changes Within the Brain: Protocol for an Observational Study",
journal="JMIR Res Protoc",
year="2020",
month="Aug",
day="10",
volume="9",
number="8",
pages="e16089",
keywords="binocular vision",
keywords="dementia",
keywords="magnetic resonance imaging",
keywords="stereopsis",
keywords="pupil",
keywords="sleep",
abstract="Background: Visual impairment is a common comorbidity in people living with dementia. Addressing sources of visual difficulties can have a significant impact on the quality of life for people living with dementia and their caregivers. Depth perception problems are purportedly common in dementia and also contribute to falls, visuomotor task difficulties, and poorer psychosocial well-being. However, depth perception and binocular vision are rarely assessed in dementia research. Sleep fragmentation is also common for people living with dementia, and binocular cooperation for depth perception can be affected by fatigue. Pupillary responses under cognitive load also have the potential to be a risk marker for cognitive decline in people living with dementia and can be combined with the above measures for a comprehensive evaluation of clinical visual changes in people living with dementia and their relation to changes in cognitive status, sleep quality, and cortical structure or function. Objective: This study aims to characterize the nature of clinical visual changes and altered task-evoked pupillary responses that may occur in people living with dementia and evaluate whether these responses relate to changes in cognitive status (standardized Mini Mental State Examination [MMSE] score), Pittsburgh sleep quality index, and cortical structure or function. Methods: This proposed exploratory observational study will enroll ?210 people with recently diagnosed dementia (within the last 24 months). The following parameters will be assessed on 3 occasions, 4 months apart (plus or minus 2 weeks): visual function (visual acuity and contrast sensitivity), binocular function (motor fusion and stereopsis), task-evoked pupillary responses (minimum and maximum pupil size, time to maximum dilation, and dilation velocity), cognitive status (MMSE score), and sleep quality (Pittsburgh Sleep Quality Index). A subset of patients (n=30) with Alzheimer disease will undergo structural and functional magnetic resonance imaging at first and third visits, completing a 10-day consensus sleep diary to monitor sleep quality, verified by sleep actimetry. Results: This research was funded in February 2018 and received National Health Service Research Ethics Committee approval in September 2018. The data collection period was from October 1, 2018, to November 30, 2019. A total of 24 participants were recruited for the study. The data analysis is complete, with results expected to be published before the end of 2020. Conclusions: Findings will demonstrate how often people with dementia experience binocular vision problems. If frequent, diagnosing and treating them could improve quality of life by reducing the risk of falls and fine visuomotor task impairment and by relieving psychosocial anxiety. This research will also demonstrate whether changes in depth perception, pupillary responses, and quality of vision relate to changes in memory or sleep quality and brain structure or function. If related, these quick and noninvasive eye tests help monitor dementia. This would help justify whether binocular vision and pupillary response testing should be included in dementia-friendly eye-testing guidelines. International Registered Report Identifier (IRRID): RR1-10.2196/16089 ",
doi="10.2196/16089",
url="https://www.researchprotocols.org/2020/8/e16089",
url="http://www.ncbi.nlm.nih.gov/pubmed/32773379"
}


@Article{info:doi/10.2196/17779,
author="Oreglia, Elisa
and Ly, Sokhey
and Tijamo, Camille
and Ou, Amra
and Free, Caroline
and Smith, Chris",
title="Development of an Intervention to Support the Reproductive Health of Cambodian Women Who Seek Medical Abortion: Research Protocol",
journal="JMIR Res Protoc",
year="2020",
month="Jul",
day="10",
volume="9",
number="7",
pages="e17779",
keywords="reproductive health",
keywords="abortion",
keywords="Cambodia",
keywords="mHealth",
keywords="mobile phone",
abstract="Background: In Cambodia, abortion has been legally permitted on request during the first trimester of pregnancy since 1997. However, although there has been an increase in the percentage of women having induced abortion and medical abortion, there has also been a decrease in the percentage of women who say they received help from a health worker with their abortion. These data point toward the demedicalization of abortion, and although medical abortion has been shown to be safe, there are concerns about safety, given the variety of available products and counseling provided. These concerns are particularly relevant for female factory workers, who typically come from rural areas where access to good health care and information about reproductive health care is limited. Objective: This study aims to understand the reproductive health needs of female Cambodian garment factory workers after medical abortion from a multidisciplinary and mixed-methods perspective, focusing on how they seek and share medical abortion- and health-related information; how they use their mobile phones for this and other purposes; what cultural challenges exist around reproductive health; and how they might be magnified or mitigated by mobile phones, linguistic challenges around health care, and mobile phone use. The main purpose of this study is to combine multidisciplinary methods, theories, and expertise to gain new, culturally grounded insights into family planning and medical abortion in Cambodia, but the findings could help inform the development of a relevant intervention to support comprehensive postabortion care. Methods: The methods proposed are interviews and participant observation among factory workers, health providers, and mobile phone providers; a linguistic analysis of relevant data (interview transcripts, web-based sources, and other fieldwork materials); and digital methods to understand what kind of information about medical abortion exists on the web in Cambodia and how it is accessed by the targeted population. Results: The data collection part of the project will end on December 31, 2020. The team conducted 67 semistructured interviews with female factory workers, women who sought a medical abortion, health providers, and mobile phone providers; participant observation with factory workers and health providers; and an analysis of YouTube and Facebook to understand what kind of information is available, who creates it, and how it is used. The team is currently performing data analysis, and the findings are clustered around (1) the use of mobile phones and digital resources for health-related and medical abortion-related information, (2) the experience of medical abortion care, and (3) the development of an intervention through edutainment videos. Conclusions: The project highlights both the widely untapped potential of using digital platforms (especially YouTube and Facebook) to distribute accurate information on medical abortion and the challenges in providing individual information via mobile phones while respecting individuals' privacy. International Registered Report Identifier (IRRID): DERR1-10.2196/17779 ",
doi="10.2196/17779",
url="https://www.researchprotocols.org/2020/7/e17779",
url="http://www.ncbi.nlm.nih.gov/pubmed/32423893"
}


@Article{info:doi/10.2196/15113,
author="Kelly, J. Peter
and Beck, K. Alison
and Baker, L. Amanda
and Deane, P. Frank
and Hides, Leanne
and Manning, Victoria
and Shakeshaft, Anthony
and Larance, Briony
and Neale, Joanne
and Kelly, John
and Oldmeadow, Christopher
and Searles, Andrew
and Treloar, Carla
and Gray, M. Rebecca
and Argent, Angela
and McGlaughlin, Ryan",
title="Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in Mutual Support Groups Coordinated by SMART Recovery Australia: Protocol for a Pilot Study",
journal="JMIR Res Protoc",
year="2020",
month="Jul",
day="9",
volume="9",
number="7",
pages="e15113",
keywords="SMART Recovery",
keywords="mutual support group",
keywords="mutual aid",
keywords="routine outcome monitoring",
keywords="treatment progress feedback",
keywords="mHealth",
keywords="addiction",
keywords="mobile phone",
abstract="Background: Despite the importance and popularity of mutual support groups, there have been no systematic attempts toimplement and evaluate routine outcome monitoring (ROM) in these settings. Unlike other mutual support groups for addiction,trained facilitators lead all Self-Management and Recovery Training (SMART Recovery) groups, thereby providing an opportunityto implement ROM as a routine component of SMART Recovery groups. Objective: This study protocol aims to describe a stage 1 pilot study designed to explore the feasibility and acceptability of anovel, purpose-built mobile health (mHealth) ROM and feedback app (Smart Track) in SMART Recovery groups coordinated by SMART Recovery Australia (SRAU) The secondary objectives are to describe Smart Track usage patterns, explore psychometric properties of the ROM items (ie, internal reliability and convergent and divergent validity), and provide preliminary evidence for participant reported outcomes (such as alcohol and other drug use, self-reported recovery, and mental health). Methods: Participants (n=100) from the SMART Recovery groups across New South Wales, Australia, will be recruited to a nonrandomized, prospective, single-arm trial of the Smart Track app. There are 4 modes of data collection: (1) ROM data collected from group participants via the Smart Track app, (2) data analytics summarizing user interactions with Smart Track, (3) quantitative interview and survey data of group participants (baseline, 2-week follow-up, and 2-month follow-up), and (4) qualitative interviews with group participants (n=20) and facilitators (n=10). Feasibility and acceptability (primary objectives) will be analyzed using descriptive statistics, a cost analysis, and a qualitative evaluation. Results: At the time of submission, 13 sites (25 groups per week) had agreed to be involved. Funding was awarded on August 14, 2017, and ethics approval was granted on April 26, 2018 (HREC/18/WGONG/34; 2018/099). Enrollment is due to commence in July 2019. Data collection is due to be finalized in October 2019. Conclusions: To the best of our knowledge, this study is the first to use ROM and tailored feedback within a mutual support group setting for addictive behaviors. Our study design will provide an opportunity to identify the acceptability of a novel mHealth ROM and feedback app within this setting and provide detailed information on what factors promote or hinder ROM usage within this context. This project aims to offer a new tool, should Smart Track prove feasible and acceptable, that service providers, policy makers, and researchers could use in the future to understand the impact of SMART Recovery groups. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336. International Registered Report Identifier (IRRID): PRR1-10.2196/15113 ",
doi="10.2196/15113",
url="https://www.researchprotocols.org/2020/7/e15113",
url="http://www.ncbi.nlm.nih.gov/pubmed/32673272"
}


@Article{info:doi/10.2196/18420,
author="Weiner, S. Lauren
and Nagel, Stori
and Su, Irene H.
and Hurst, Samantha
and Hartman, J. Sheri",
title="A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation",
journal="JMIR Res Protoc",
year="2020",
month="Jul",
day="8",
volume="9",
number="7",
pages="e18420",
keywords="physical activity",
keywords="cancer survivors",
keywords="peer mentors",
keywords="quality of life",
keywords="pilot study",
keywords="breast cancer",
keywords="fitness trackers",
keywords="mobile phone",
abstract="Background: Younger breast cancer survivors consistently report a greater impact of their cancer experience on quality of life compared with older survivors, including higher rates of body image disturbances, sexual dysfunction, and fatigue. One potential strategy to improve quality of life is through physical activity, but this has been understudied in younger breast cancer survivors, who often decrease their activity during and after cancer treatment. Objective: The aim of this study is to explore the feasibility and acceptability of a technology-based, remotely delivered, peer-led physical activity intervention for younger breast cancer survivors. We will also assess the preliminary impact of the intervention on changes in physical activity and multiple aspects of quality of life. Methods: This study is a community-academic partnership between University of California, San Diego and Haus of Volta, a nonprofit organization that promotes positive self-image in younger breast cancer survivors. This ongoing pilot study aims to recruit 30 younger breast cancer survivors across the United States (<55 years old, >6 months post primary cancer treatment, self-report <60 min of moderate-to-vigorous-intensity physical activity [MVPA]) into a 3-month peer-delivered, fully remote exercise program. Participants will complete 6 biweekly video chat sessions with a trained peer mentor, a fellow younger breast cancer survivor. Participants will receive a Fitbit Charge 3; weekly feedback on Fitbit data from their peer mentor; and access to a private, in-app Fitbit Community to provide and receive support from other participants and all peer mentors. At baseline, 3 months, and 6 months, participants will complete quality of life questionnaires, and MVPA will be measured using the ActiGraph accelerometer. Feasibility and acceptability will be explored through a mixed methods approach (ie, quantitative questionnaires and qualitative interviews). Intervention delivery and adaptations by peer mentors will be tracked through peer mentor self-evaluations and reflections, review of video-recorded mentoring sessions, and monthly templated reflections by the research team. Results: Recruitment began in September 2019. As of February 2020, the physical activity intervention is ongoing. Final measures are expected to occur in summer 2020. Conclusions: This study explores the potential for physical activity to improve sexual function, body image, and fatigue, key quality of life issues in younger breast cancer survivors. Using peer mentors extends our reach into the young survivor community. The detailed process evaluation of intervention delivery and adaptations by mentors could inform a future hybrid-effectiveness implementation trial. Finally, remote delivery with commercially available technology could promote broader dissemination. Trial Registration: ClinicalTrials.gov NCT04064892; https://clinicaltrials.gov/ct2/show/NCT04064892 International Registered Report Identifier (IRRID): DERR1-10.2196/18420 ",
doi="10.2196/18420",
url="https://www.researchprotocols.org/2020/7/e18420",
url="http://www.ncbi.nlm.nih.gov/pubmed/32673270"
}


@Article{info:doi/10.2196/16861,
author="Greenhalgh, Trisha
and Maylor, Harvey
and Shaw, Sara
and Wherton, Joseph
and Papoutsi, Chrysanthi
and Betton, Victoria
and Nelissen, Natalie
and Gremyr, Andreas
and Rushforth, Alexander
and Koshkouei, Mona
and Taylor, John",
title="The NASSS-CAT Tools for Understanding, Guiding, Monitoring, and Researching Technology Implementation Projects in Health and Social Care: Protocol for an Evaluation Study in Real-World Settings",
journal="JMIR Res Protoc",
year="2020",
month="May",
day="13",
volume="9",
number="5",
pages="e16861",
keywords="evaluation",
keywords="complexity",
keywords="theory-driven evaluation",
keywords="diffusion of innovation",
keywords="scale-up",
keywords="sustainability",
keywords="implementation",
keywords="NASSS (nonadoption, abandonment, scale-up, spread, sustainability) framework",
keywords="innovation adoption",
keywords="project management",
abstract="Background: Projects to implement health care and social care innovations involving technologies are typically ambitious and complex. Many projects fail. Greenhalgh et al's nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework was developed to analyze the varied outcomes of such projects. Objective: We sought to extend the NASSS framework to produce practical tools for understanding, guiding, monitoring, and researching technology projects in health care or social care settings. Methods: Building on NASSS and a complexity assessment tool (CAT), the NASSS-CAT tools were developed (in various formats) in seven co-design workshops involving 50 stakeholders (industry executives, technical designers, policymakers, managers, clinicians, and patients). Using action research, they were and are being tested prospectively on a sample of case studies selected for variety in conditions, technologies, settings, scope and scale, policy context, and project goals. Results: The co-design process resulted in four tools, available as free downloads. NASSS-CAT SHORT is a taster to introduce the instrument and gauge interest. NASSS-CAT LONG is intended to support reflection, due diligence, and preliminary planning. It maps complexity through stakeholder discussion across six domains, using free-text open questions (designed to generate a rich narrative and surface uncertainties and interdependencies) and a closed-question checklist; this version includes an action planning section. NASSS-CAT PROJECT is a 35-item instrument for monitoring how subjective complexity in a technology implementation project changes over time. NASSS-CAT INTERVIEW is a set of prompts for conducting semistructured research or evaluation interviews. Preliminary data from empirical case studies suggest that the NASSS-CAT tools can potentially identify, but cannot always help reconcile, contradictions and conflicts that block projects' progress. Conclusions: The NASSS-CAT tools are a useful addition to existing implementation tools and frameworks. Further support of the implementation projects is ongoing. We are currently producing digital versions of the tools, and plan (subject to further funding) to establish an online community of practice for people interested in using and improving the tools, and hold workshops for building cross-project collaborations. International Registered Report Identifier (IRRID): DERR1-10.2196/16861 ",
doi="10.2196/16861",
url="https://www.researchprotocols.org/2020/5/e16861",
url="http://www.ncbi.nlm.nih.gov/pubmed/32401224"
}


@Article{info:doi/10.2196/15756,
author="Healy, Nissa Genevieve
and Goode, D. Ana
and Abbott, Alison
and Burzic, Jennifer
and Clark, K. Bronwyn
and Dunstan, W. David
and Eakin, G. Elizabeth
and Frith, Matthew
and Gilson, D. Nicholas
and Gao, Lan
and Gunning, Lynn
and Jetann, Jodie
and LaMontagne, D. Anthony
and Lawler, P. Sheleigh
and Moodie, Marjory
and Nguyen, Phuong
and Owen, Neville
and Straker, Leon
and Timmins, Perri
and Ulyate, Lisa
and Winkler, H. Elisabeth A.",
title="Supporting Workers to Sit Less and Move More Through the Web-Based BeUpstanding Program: Protocol for a Single-Arm, Repeated Measures Implementation Study",
journal="JMIR Res Protoc",
year="2020",
month="May",
day="4",
volume="9",
number="5",
pages="e15756",
keywords="implementation trial",
keywords="workplace",
keywords="sitting",
keywords="health promotion",
keywords="activity",
keywords="health and safety",
keywords="public health",
keywords="occupational",
keywords="evaluation",
keywords="web-based",
abstract="Background: The web-based BeUpstanding Champion Toolkit was developed to support work teams in addressing the emergent work health and safety issue of excessive sitting. It provides a step-by-step guide and associated resources that equip a workplace representative---the champion---to adopt and deliver the 8-week intervention program (BeUpstanding) to their work team. The evidence-informed program is designed to raise awareness of the benefits of sitting less and moving more, build a supportive culture for change, and encourage staff to take action to achieve this change. Work teams collectively choose the strategies they want to implement and promote to stand up, sit less, and move more, with this bespoke and participative approach ensuring the strategies are aligned with the team's needs and existing culture. BeUpstanding has been iteratively developed and optimized through a multiphase process to ensure that it is fit for purpose for wide-scale implementation. Objective: The study aimed to describe the current version of BeUpstanding, and the methods and protocol for a national implementation trial. Methods: The trial will be conducted in collaboration with five Australian workplace health and safety policy and practice partners. Desk-based work teams from a variety of industries will be recruited from across Australia via partner-led referral pathways. Recruitment will target sectors (small business, rural or regional, call center, blue collar, and government) that are of priority to the policy and practice partners. A minimum of 50 work teams will be recruited per priority sector with a minimum of 10,000 employees exposed to the program. A single-arm, repeated-measures design will assess the short-term (end of program) and long-term (9 months postprogram) impacts. Data will be collected on the web via surveys and toolkit analytics and by the research team via telephone calls with champions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework will guide the evaluation, with assessment of the adoption/reach of the program (the number and characteristics of work teams and participating staff), program implementation (completion by the champion of core program components), effectiveness (on workplace sitting, standing, and moving), and maintenance (sustainability of changes). There will be an economic evaluation of the costs and outcomes of scaling up to national implementation, including intervention affordability and sustainability. Results: The study received funding in June 2018 and the original protocol was approved by institutional review board on January 9, 2017, with national implementation trial consent and protocol amendment approved March 12, 2019. The trial started on June 12, 2019, with 48 teams recruited as of December 2019. Conclusions: The implementation and multimethod evaluation of BeUpstanding will provide the practice-based evidence needed for informing the potential broader dissemination of the program. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000682347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372843\&isReview=true. International Registered Report Identifier (IRRID): DERR1-10.2196/15756 ",
doi="10.2196/15756",
url="https://www.researchprotocols.org/2020/5/e15756",
url="http://www.ncbi.nlm.nih.gov/pubmed/32364513"
}


@Article{info:doi/10.2196/17714,
author="Billis, Antonis
and Pandria, Niki
and Mouratoglou, Sophia-Anastasia
and Konstantinidis, Evdokimos
and Bamidis, Panagiotis",
title="Development of Cognitive and Physical Exercise Systems, Clinical Recordings, Large-Scale Data Analytics, and Virtual Coaching for Heart Failure Patients: Protocol for the BioTechCOACH-ForALL Project",
journal="JMIR Res Protoc",
year="2020",
month="May",
day="4",
volume="9",
number="5",
pages="e17714",
keywords="chronic heart failure",
keywords="treatment adherence",
keywords="exergames",
keywords="e-coaching",
keywords="adherence",
keywords="electroencephalogram",
keywords="wearable monitoring",
abstract="Background: Heart failure is a chronic disease affecting patient morbidity and mortality. Current guidelines for heart failure patient treatment are focused on improving their clinical status, functional capacity, and quality of life. However, these guidelines implement numerous instructions including medical treatment adherence, physical activity, and self-care management. The complexity of the therapeutic instructions makes them difficult to follow especially by older adults. Objective: The challenge of this project is to (1) measure real-life adherence to a regular physical exercise program and (2) attempt to influence older adult patients with heart failure toward embracing a more physically active self-care lifestyle. Methods: This research consists of two studies, including a lab experiment and a pragmatic evaluation of technology at patients' homes. The lab experiment aims at exploring in an objective way (measuring neurophysiological responses to stimuli) patient engagement with different characteristics of virtual agents, while the home study is a 3-phase prospective study where the developed technology platform is tested by heart failure patients in their own home environments. Patients undergo evaluation of their physical activity and cognitive status using standard evaluation methods (6-minute walk test, questionnaires) and receive wearable devices to accurately measure everyday life activity levels (home study phases 1-3). During home study phases 2 and 3, exergames (serious games for physical exercise) to provide a physical exercise plan as a joyful activity are delivered to patients' private households and e-coaching techniques are implemented in the final phase (home study phase 3) of the protocol, to influence patient attitudes toward a more healthy and recommended lifestyle. Results: The trial is still ongoing. Recruitment is ongoing, and the project has progressed for some participants through phase 2 of the home study. The sample size for both studies is 28 participants; 10 have already been included in the study, and both baseline clinical and patient-reported outcome data are retrieved. Phases 2 and 3 of the home pilot study are expected to be completed within 6 months. Conclusions: The main challenge of the project is the change of attitude of older age heart failure patients through an e-coaching system. Given the adoption of a cocreation and living lab approach and the main objective for real-life evaluation, the project is ready to react to any collected feedback, even during the implementation of the research plan. Clinical assessment and objective evaluation are expected to provide all required information for reliable findings. Trial Registration: ClinicalTrials.gov NCT03877328; https://clinicaltrials.gov/ct2/show/NCT03877328 International Registered Report Identifier (IRRID): DERR1-10.2196/17714 ",
doi="10.2196/17714",
url="https://www.researchprotocols.org/2020/5/e17714",
url="http://www.ncbi.nlm.nih.gov/pubmed/32364512"
}


@Article{info:doi/10.2196/16945,
author="Lal, Shalini
and Starcevic, Joanna Danielle
and Fuhrer, Rebecca",
title="Youth Experiences With Referrals to Mental Health Services in Canada: Protocol for a Web-Based Cross-Sectional Survey Study",
journal="JMIR Res Protoc",
year="2020",
month="Mar",
day="24",
volume="9",
number="3",
pages="e16945",
keywords="mental disorders",
keywords="health care quality, access, and evaluation",
keywords="mental health",
keywords="psychology",
keywords="telemedicine",
keywords="young adult",
keywords="health services accessibility",
keywords="technology",
keywords="referral and consultation",
abstract="Background: Youth mental health is an important public health concern affecting low-, middle-, and high-income countries, and many young people in need of mental health services do not receive the care they need when they need it. An early step in accessing mental health care is the referral process, yet most of the research done on pathways to care has focused on clinical populations (eg, first-episode psychosis) recruited from mental health care settings. There has been limited research attention on the experiences of referral to mental health services from the perspectives of youth recruited from the general population who may or may not have received the services they need. Objective: This study aims to investigate the experiences that youth between the ages of 17 and 30 years have with referrals to mental health services and to better understand their perspectives on the use of technology to facilitate referrals. Methods: This study will use a cross-sectional, Web-based survey design. A convenience sample of 400 participants from 3 Canadian provinces (Quebec, Ontario, and British Columbia), between the ages of 17 and 30 years, will be recruited via Facebook and will be invited to complete a Web-based survey anonymously. A questionnaire including a series of quantitative and qualitative questions will ask participants about their sociodemographic characteristics, past experiences with referral and access to mental health services, and opinions about using technology to facilitate the referral process. Results: Participant recruitment is planned to be initiated by early January 2020 and is estimated to be completed by May 2020. Data will be analyzed using descriptive statistics and logistic regression or chi-square tests for quantitative data, and descriptive content analysis will be used for the qualitative data. Conclusions: The results of this study can help inform the improvement of referral policies and procedures in youth mental health service delivery. A better understanding of young people's perspectives on referral processes and their opinions on how these processes can be improved are essential to providing appropriate and timely access to mental health care. International Registered Report Identifier (IRRID): PRR1-10.2196/16945 ",
doi="10.2196/16945",
url="http://www.researchprotocols.org/2020/3/e16945/",
url="http://www.ncbi.nlm.nih.gov/pubmed/32207698"
}


@Article{info:doi/10.2196/14743,
author="Op de Coul, Eline
and den Daas, Chantal
and Spijker, Ralph
and Heijman, Titia
and de Vos, Marvin
and G{\"o}tz, Hannelore
and Vermey, Koenraad
and Zuilhof, Wim
and Van den Boogaard, Jossy
and Davidovich, Udi
and Zuure, Freke
and ",
title="Web-Supported Social Network Testing for HIV Among Men Who Have Sex With Men With a Migration Background: Protocol for a Mixed Methods Pilot Study",
journal="JMIR Res Protoc",
year="2020",
month="Feb",
day="10",
volume="9",
number="2",
pages="e14743",
keywords="HIV",
keywords="social network testing (SNT)",
keywords="men who have sex with men (MSM)",
keywords="community-based testing",
keywords="HIV self-testing",
abstract="Background: Of newly diagnosed HIV positive men who have sex with men (MSM) in the Netherlands, 29\% have a non-Western migration background (MSM-NW). Among MSM-NW, HIV positivity rates are high (0.8\%-2.0\%), as is the proportion of late stage infections (39\%). Factors such as HIV and sexual orientation--related stigma may form barriers for timely testing. Innovative approaches for HIV testing are needed to better reach MSM-NW. Social network testing (SNT) for HIV is an evidence-supported approach where peer recruiters identify persons (network associates) who could benefit from testing in their social or sexual networks. Web-supported SNT might be particularly promising for reaching people who may not be reached by regular care. Objective: The purpose of this paper is to describe the design of our pilot PREVENT (Peer-Empowered Voluntary Extended Network Testing). In this pilot, we will explore whether SNT using HIV self-tests is feasible and acceptable among MSM-NW in the Netherlands and whether it reaches those who were never or not recently tested for HIV (>1 year ago). Methods: The project aims to include 50 to 60 MSM and MSM-NW peers who will distribute 4 to 5 oral HIV self-tests each aiming to reach 200 network associates (NAs). Enrollment of peers includes 4 steps: (1) fostering interest in becoming a peer by health care professionals at sexual health clinics, HIV treatment clinics, and community settings; (2) sending peer contact information to the peer coordinator; (3) registering peers and giving program instructions by the peer coordinator and referring to the Web-based training at time2test; and (4) receiving precoded HIV self-tests for distribution in the peers' networks. NAs who receive the self-test will log in with their test package code in the time2test application for step-by-step test instructions. After testing is complete, NAs receive tailored follow-up information depending on their test result. Results: Between January and May 2019, 10 STI clinics and 7 HIV treatment clinics started recruiting peers. Results of the PREVENT pilot are expected in December 2020. Conclusions: This is the first Web-supported peer-driven SNT pilot using HIV self-tests in the Netherlands and one of the first in Europe. Implementation is considered successful if it reaches MSM-NW who were never or not recently tested for HIV. Additionally, it may encourage conversations within the networks about risk behavior and barriers to HIV testing, potentially contributing to the Joint United Nations Programme on HIV/AIDS goal of zero HIV infections. Trial Registration: Netherlands Trial Registry NL7424; https://www.trialregister.nl/trial/7424 International Registered Report Identifier (IRRID): DERR1-10.2196/14743 ",
doi="10.2196/14743",
url="https://www.researchprotocols.org/2020/2/e14743"
}


@Article{info:doi/10.2196/15299,
author="De Marchi, Bertoletti Ana Carolina
and Alves, Anna Ana Luisa Sant'
and Gon{\c{c}}alves, Crivellaro Carla Beatrice
and Cervi, Roberto Cristiano
and Biduski, Daiana
and Bellei, Andrei Ericles
and Madalozzo, Afonso Guilherme
and Da Cruz, M{\^a}nica Ivana Beatrice
and Veiga, Emanoelli Jeangrei
and Rodriguez, Mazuco Jo{\~a}o Pedro
and Ferretto, Rodrigo Luciano
and Bin, Pereira Luiz Carlos
and Rebonatto, Trindade Marcelo
and Portella, Rodrigues Marilene
and Roman, Klein Mateus
and Cechetti, Pinto Nath{\'a}lia
and Rieder, Rafael
and Debon, Raquel
and Volpi, Salete Simiane",
title="An Electronic Health Platform for Monitoring Health Conditions of Patients With Hypertension in the Brazilian Public Health System: Protocol for a Nonrandomized Controlled Trial",
journal="JMIR Res Protoc",
year="2020",
month="Jan",
day="20",
volume="9",
number="1",
pages="e15299",
keywords="hypertension",
keywords="eHealth",
keywords="mHealth",
keywords="public health",
keywords="Brazil",
abstract="Background: Chronic noncommunicable diseases such as arterial hypertension have a high impact in the context of public health. Previous studies have shown improvements in blood pressure due to simple lifestyle changes, which were supported by electronic health (eHealth) solutions. Objective: The aim of this study is to develop an eHealth platform and assess the effects of its use on the health conditions of patients with hypertension, with assistance from health professionals in the public health system of a Brazilian city. Methods: The platform will include a server that centralizes all the data and business rules, a website dashboard for health professionals, and a mobile app for patients. We will analyze the effects of its use through a controlled, nonrandomized, nonblind, prospective, monocentric clinical trial. We will enroll 68 participants diagnosed with arterial hypertension and under medical follow-up and categorize them into two groups. The participants of the intervention group will use the platform as a monitoring method, whereas the participants of the control group will use conventional methods. In both groups, we will assess and compare the evolution of blood pressure and treatment adherence before, during, and after the intervention. Results: The project was funded at the end of 2018. We have been developing the software since 2019 with plans to complete it in 2020, and we will enroll patients between 2020 and 2021. We expect to submit the first results for publication in 2020. Conclusions: For the primary outcome, we expect a reduction and stabilization of blood pressure. For the secondary outcomes, we hope to see improvements in treatment adherence, physical activities and dietary practices, and acceptance of the eHealth platform. In public health, the technology that favors disease control also helps reduce complications and, consequently, treatment costs. The platform might encourage the adaptation of medical assistance to incorporate this technology into patient monitoring. International Registered Report Identifier (IRRID): PRR1-10.2196/15299 ",
doi="10.2196/15299",
url="http://www.researchprotocols.org/2020/1/e15299/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31958068"
}


@Article{info:doi/10.2196/16406,
author="Arayasirikul, Sean
and Trujillo, Dillon
and Turner, M. Caitlin
and Le, Victory
and Wilson, C. Erin",
title="Implementing a Digital HIV Care Navigation Intervention (Health eNav): Protocol for a Feasibility Study",
journal="JMIR Res Protoc",
year="2019",
month="Nov",
day="8",
volume="8",
number="11",
pages="e16406",
keywords="HIV/AIDS",
keywords="digital navigation",
keywords="young people living with HIV",
keywords="mHealth",
abstract="Background: Young racial and ethnic minority men who have sex with men (MSM) and trans women are disproportionately affected by HIV and AIDS in the United States. Unrecognized infection, due to a low uptake of HIV testing, and poor linkage to care are driving forces of ongoing HIV transmission among young racial and ethnic minority MSM and trans women. Internet and mobile technologies, in combination with social network-based approaches, offer great potential to overcome and address barriers to care and effectively disseminate interventions. Objective: We describe Health eNavigation (Health eNav), a digital HIV care navigation intervention that extends supportive care structures beyond clinic walls to serve youth and young adults living with HIV who are newly diagnosed, not linked to care, out of care, and not virally suppressed, at times when they need support the most. Methods: This study leverages ecological momentary assessments for a period of 90 days and uses person-delivered short message service text messages to provide participants with digital HIV care navigation over a 6-month period. We aim to improve engagement, linkage, and retention in HIV care and improve viral suppression. Digital HIV care navigation includes the following components: (1) HIV care navigation, (2) health promotion, (3) motivational interviewing, and (4) digital social support. Results: Recruitment began on November 18, 2016; enrollment closed on May 31, 2018. Intervention delivery ended on November 30, 2018, and follow-up evaluations concluded on October 31, 2019. In this paper, we present baseline sample characteristics. Conclusions: We discuss real-world strategies and challenges in delivering the digital HIV care navigation intervention in a city-level, public health setting. International Registered Report Identifier (IRRID): DERR1-10.2196/16406 ",
doi="10.2196/16406",
url="http://www.researchprotocols.org/2019/11/e16406/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31702561"
}


@Article{info:doi/10.2196/13434,
author="Rasing, A. Sanne P.
and Stikkelbroek, J. Yvonne A.
and Riper, Heleen
and Dekovic, Maja
and Nauta, H. Maaike
and Dirksen, D. Carmen
and Creemers, M. Daan H.
and Bodden, M. Denise H.",
title="Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial",
journal="JMIR Res Protoc",
year="2019",
month="Oct",
day="7",
volume="8",
number="10",
pages="e13434",
keywords="depression",
keywords="major depressive disorder",
keywords="cognitive behavioral therapy",
keywords="blended",
keywords="eHealth",
keywords="online",
keywords="adolescents",
keywords="effectiveness",
keywords="cost-effectiveness",
abstract="Background: Cognitive behavioral therapy (CBT) is an effective intervention to treat depressive disorders in youth. However, 50\% of adolescents still have depressive symptoms after treatment, and 57\% drop out during treatment. Online CBT interventions have proven to be effective in reducing depressive symptoms and seem promising as a treatment for depressed adolescents. However, combining online programs with face-to-face sessions seems necessary to increase their effectiveness and monitor for suicide risk. Objective: In this study, we examine the effectiveness and cost-effectiveness of a blended CBT treatment protocol, a mixture of online and face-to-face CBT, as a treatment for clinically depressed adolescents. Methods: A pragmatic quasi-experimental controlled trial will be conducted to study the effectiveness of a blended CBT treatment protocol, in which blended CBT is compared with face-to-face CBT (n=44) and treatment as usual (n=44); the latter two were collected in a previous randomized controlled trial. The same inclusion and exclusion criteria will be used: adolescents aged between 12 and 21 years, with a clinical diagnosis of a depressive disorder, and referred to one of the participating mental health institutions. Assessments will be conducted at the same time points: before the start of the intervention, during the intervention (after 5 and 10 weeks), postintervention, and at 6- and 12-month follow-ups. Results: The primary outcome is the presence of a depression diagnosis at 12-month follow-up. Several secondary outcomes will be measured, such as depressive symptoms, quality of life, and suicide risk. Costs and effects in both conditions will be compared to analyze cost-effectiveness. Further, moderating (age, gender, alcohol and drug use, parental depression, and other psychopathology) and mediating effects (negative automatic thoughts, cognitive emotion regulation, attributional style) will be analyzed. Also, treatment characteristics will be studied, such as characteristics of the therapists, treatment expectancy, and therapeutic alliance. Dropout rates and treatment characteristics will be measured to study the feasibility of blended CBT. Conclusions: This study will examine the effectiveness and cost-effectiveness of a blended CBT program in which depressed adolescents are treated in mental health care. Results of blended CBT will be compared with face-to-face CBT and treatment as usual, and implications for implementation will be reviewed. Trial Registration: Dutch Trial Register (NTR6759); http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6759 International Registered Report Identifier (IRRID): DERR1-10.2196/13434 RR1-10.2196/12654 ",
doi="10.2196/13434",
url="https://www.researchprotocols.org/2019/10/e13434",
url="http://www.ncbi.nlm.nih.gov/pubmed/31593538"
}


@Article{info:doi/10.2196/13685,
author="L{\"u}scher, Janina
and Kowatsch, Tobias
and Boateng, George
and Santhanam, Prabhakaran
and Bodenmann, Guy
and Scholz, Urte",
title="Social Support and Common Dyadic Coping in Couples' Dyadic Management of Type II Diabetes: Protocol for an Ambulatory Assessment Application",
journal="JMIR Res Protoc",
year="2019",
month="Oct",
day="4",
volume="8",
number="10",
pages="e13685",
keywords="social support",
keywords="common dyadic coping",
keywords="type II diabetes",
keywords="dyadic illness management",
keywords="couples",
keywords="mobile sensing",
keywords="multimodal sensor data",
keywords="ambulatory assessment application",
keywords="MobileCoach",
keywords="study protocol",
abstract="Background: Type II diabetes mellitus (T2DM) is a common chronic disease. To manage blood glucose levels, patients need to follow medical recommendations for healthy eating, physical activity, and medication adherence in their everyday life. Illness management is mainly shared with partners and involves social support and common dyadic coping (CDC). Social support and CDC have been identified as having implications for people's health behavior and well-being. Visible support, however, may also be negatively related to people's well-being. Thus, the concept of invisible support was introduced. It is unknown which of these concepts (ie, visible support, invisible support, and CDC) displays the most beneficial associations with health behavior and well-being when considered together in the context of illness management in couple's everyday life. Therefore, a novel ambulatory assessment application for the open-source behavioral intervention platform MobileCoach (AAMC) was developed. It uses objective sensor data in combination with self-reports in couple's everyday life. Objective: The aim of this paper is to describe the design of the Dyadic Management of Diabetes (DyMand) study, funded by the Swiss National Science Foundation (CR12I1\_166348/1). The study was approved by the cantonal ethics committee of the Canton of Zurich, Switzerland (Req-2017\_00430). Methods: This study follows an intensive longitudinal design with 2 phases of data collection. The first phase is a naturalistic observation phase of couples' conversations in combination with experience sampling in their daily lives, with plans to follow 180 T2DM patients and their partners using sensor data from smartwatches, mobile phones, and accelerometers for 7 consecutive days. The second phase is an observational study in the laboratory, where couples discuss topics related to their diabetes management. The second phase complements the first phase by focusing on the assessment of a full discussion about diabetes-related concerns. Participants are heterosexual couples with 1 partner having a diagnosis of T2DM. Results: The AAMC was designed and built until the end of 2018 and internally tested in March 2019. In May 2019, the enrollment of the pilot phase began. The data collection of the DyMand study will begin in September 2019, and analysis and presentation of results will be available in 2021. Conclusions: For further research and practice, it is crucial to identify the impact of social support and CDC on couples' dyadic management of T2DM and their well-being in daily life. Using AAMC will make a key contribution with regard to objective operationalizations of visible and invisible support, CDC, physical activity, and well-being. Findings will provide a sound basis for theory- and evidence-based development of dyadic interventions to change health behavior in the context of couple's dyadic illness management. Challenges to this multimodal sensor approach and its feasibility aspects are discussed. International Registered Report Identifier (IRRID): PRR1-10.2196/13685 ",
doi="10.2196/13685",
url="https://www.researchprotocols.org/2019/10/e13685",
url="http://www.ncbi.nlm.nih.gov/pubmed/31588907"
}


@Article{info:doi/10.2196/13268,
author="Finocchario-Kessler, Sarah
and Maloba, May
and Brown, Melinda
and Gautney, Brad
and Goggin, Kathy
and Wexler, Catherine
and Mabachi, Natabhona
and Odeny, Beryne
and Lagat, Silas
and Koech, Sharon
and Dariotis, K. Jacinda
and Odeny, A. Thomas",
title="Adapting the HIV Infant Tracking System to Support Prevention of Mother-to-Child Transmission of HIV in Kenya: Protocol for an Intervention Development Pilot Study in Two Hospitals",
journal="JMIR Res Protoc",
year="2019",
month="Jun",
day="8",
volume="8",
number="6",
pages="e13268",
keywords="HIV",
keywords="eHealth",
keywords="mHealth",
keywords="pregnancy",
keywords="retention",
keywords="medication adherence",
keywords="infant",
keywords="diagnosis",
keywords="Kenya",
abstract="Background: Despite progress to expand access to HIV testing and treatment during pregnancy in Kenya, gaps still remain in prevention of mother-to-child transmission of HIV (PMTCT) services. This study addresses the need for effective and scalable interventions to support women throughout the continuum of care for PMTCT services in low-resource settings. Our research team has successfully implemented the HIV Infant Tracking System (HITSystem), a Web-based, system-level intervention to improve early infant diagnosis (EID) outcomes. Objective: This study will expand the scope of the HITSystem to address PMTCT services to bridge the gap between maternal and pediatric HIV services and improve outcomes. This paper describes the intervention development protocol to adapt and pilot an HITSystem version 2.0 to assess acceptability, feasibility, and preliminary PMTCT outcomes in Kenya. Methods: This is a 3-year intervention development study to adapt the current HITSystem intervention to support a range of PMTCT outcomes including appointment attendance, antiretroviral therapy (ART) adherence, hospital deliveries, and integration of maternal and pediatric HIV services in low-resource settings. The study will be conducted in 3 phases. Phase 1 will elicit feedback from intervention users (patients and providers) to guide development and refinement of the new PMTCT components and inform optimal implementation. In Phase 2, we will design and develop the HITSystem 2.0 features to support key PMTCT outcomes guided by clinical content experts and findings from Phase 1. Phase 3 will assess complete PMTCT retention (before, during, and after delivery) using a matched randomized pilot study design in 2 hospitals over 18 months. A total of N=108 HIV-positive pregnant women (n=54 per site) will be enrolled and followed from their first PMTCT appointment until infant HIV DNA Polymerase Chain Reaction testing at the target age of 6 weeks (<7 weeks) postnatal. Results: Funding for this study was received in August 2015, enrollment in Phase 1 began in March 2016, and completion of data collection is expected by May 2019. Conclusions: This protocol will extend, adapt, and pilot an HITSystem 2.0 version to improve attendance of PMTCT appointments, increase ART adherence and hospital-based deliveries, and prompt EID by 6 weeks postnatal. The HITSystem 2.0 aims to improve the integration of maternal and pediatric HIV services. Trial Registration: ClinicalTrials.gov NCT02726607; https://clinicaltrials.gov/ct2/show/NCT02726607 (Archived by WebCite at http://www.webcitation.org/78VraLrOb) International Registered Report Identifier (IRRID): DERR1-10.2196/13268 ",
doi="10.2196/13268",
url="https://www.researchprotocols.org/2019/6/e13268/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31199305"
}


@Article{info:doi/10.2196/12647,
author="Marshall, Skye
and van der Meij, S. Barbara
and Milte, Rachel
and Collins, E. Clare
and de van der Schueren, AE Marian
and Banbury, Mark
and Warner, M. Molly
and Isenring, Elizabeth",
title="Family in Rehabilitation, Empowering Carers for Improved Malnutrition Outcomes: Protocol for the FREER Pilot Study",
journal="JMIR Res Protoc",
year="2019",
month="Apr",
day="30",
volume="8",
number="4",
pages="e12647",
keywords="carers",
keywords="protein-energy malnutrition",
keywords="telehealth",
keywords="intervention",
keywords="pilot study",
keywords="older adults",
keywords="subacute",
keywords="rehabilitation",
keywords="aged",
abstract="Background: Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of aging communities and are particularly relevant in the rehabilitation setting. Objective: The primary outcome aimed to determine if the FREER (Family in Rehabilitation: EmpowERing Carers for improved malnutrition outcomes) intervention in malnourished older adults during and postrehabilitation improve nutritional status, physical function, quality of life, service satisfaction, and hospital and aged care admission rates up to 3 months postdischarge, compared with usual care. Secondary outcomes evaluated include family carer burden, carer services satisfaction, and patient and carer experiences. This pilot study will also assess feasibility and intervention fidelity to inform a larger randomized controlled trial. Methods: This protocol is for a mixed-methods two-arm historically-controlled prospective pilot study intervention. The historical control group has 30 participants, and the pilot intervention group aims to recruit 30 patient-carer pairs. The FREER intervention delivers nutrition counseling during rehabilitation, 3 months of postdischarge telehealth follow-up, and provides supportive resources using a novel model of patient-centered and carer-centered nutrition care. The primary outcome is nutritional status measured by the Scored Patient-Generated Subjective Global Assessment Score. Qualitative outcomes such as experiences and perceptions of value will be measured using semistructured interviews followed by thematic analysis. The process evaluation addresses intervention fidelity and feasibility. Results: Recruitment commenced on July 4, 2018, and is ongoing with eight patient-carer pairs recruited at the time of manuscript submission. Conclusions: This research will inform a larger randomized controlled trial, with potential for translation to health service policies and new models of dietetic care to support the optimization of nutritional status across a continuum of nutrition care from rehabilitation to home. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ACTRN) 12618000338268; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374608\&isReview=true (Archived by WebCite at http://www.webcitation.org/74gtZplU2). International Registered Report Identifier (IRRID): DERR1-10.2196/12647 ",
doi="10.2196/12647",
url="https://www.researchprotocols.org/2019/4/e12647/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31038466"
}


@Article{info:doi/10.2196/11634,
author="Latulippe, Karine
and Guay, Manon
and {\'E}thier, Sophie
and S{\'e}vigny, Andr{\'e}e
and Dub{\'e}, V{\'e}ronique
and Provencher, V{\'e}ronique
and Poulin, Val{\'e}rie
and Giguere, MC Anick
and Tremblay, M{\'e}lanie
and Carignan, Maude
and Giroux, Dominique",
title="Supporting the Process of Help-Seeking by Caregivers of Functionally Dependent Older Persons Through Electronic Health: Protocol for a Multicenter Co-Design",
journal="JMIR Res Protoc",
year="2019",
month="Apr",
day="26",
volume="8",
number="4",
pages="e11634",
keywords="caregivers",
keywords="aged",
keywords="help-seeking behavior, community-based participatory research",
keywords="eHealth",
keywords="telemedicine",
abstract="Background: It is often only when the initial signs of exhaustion appear that caregivers first may engage in help-seeking behavior, but it is difficult for them to know which is the most appropriate formal service in their situation. Electronic health (eHealth) can support caregivers in keeping the older person they are caring for at home, but few eHealth tools designed for supporting the process of help-seeking by caregivers of functionally impaired older persons have been developed using a co-design approach. Objective: This paper aims to describe the protocol of a project that tries to assist caregivers to target their needs and those of the older person they support early in their help-seeking process, and guide them effectively to the formal service most appropriate for their situation. This project aims to answer the following questions: (1) What type of tool can better support caregivers to identify their needs and those of the older person they are caring for and then refer them to an appropriate formal service? and (2) What information should be found in such a tool? Methods: This study presents a description of the process of an ongoing multicenter research project based on a co-design approach, which includes 3 phases (1) identification of caregivers' needs in terms of tools to support their help-seeking behavior, (2) development of a tool, and (3) evaluation of its usability. Results: The project began in January 2016 with the ethics application for the 3 phases of the project. For phase 1, recruitment began in December 2016 and ended in September 2017. Phase 2 began in the spring of 2017 and ended in June 2018. All the co-design sessions have been completed. Phase 3 of the project will begin in September 2018. Conclusions: Although there are some challenges associated with this type of methodology, the methodology still remains relevant, as it involves future users in the development of a tool, which increases the chances that the tool will meet the users' needs. International Registered Report Identifier (IRRID): DERR1-10.2196/11634 ",
doi="10.2196/11634",
url="http://www.researchprotocols.org/2019/4/e11634/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31025956"
}


@Article{info:doi/10.2196/11718,
author="Heron, E. Kristin
and Lewis, J. Robin
and Shappie, T. Alexander
and Dawson, A. Charlotte
and Amerson, Rachel
and Braitman, L. Abby
and Winstead, A. Barbara
and Kelley, L. Michelle",
title="Rationale and Design of a Remote Web-Based Daily Diary Study Examining Sexual Minority Stress, Relationship Factors, and Alcohol Use in Same-Sex Female Couples Across the United States: Study Protocol of Project Relate",
journal="JMIR Res Protoc",
year="2019",
month="Feb",
day="04",
volume="8",
number="2",
pages="e11718",
keywords="sexual and gender minorities",
keywords="ecological momentary assessment",
keywords="alcohol drinking",
keywords="family relations",
keywords="stress, psychological",
abstract="Background: The Healthy People 2020 initiative aims to reduce health disparities, including alcohol use, among sexual minority women (SMW; eg, lesbian, bisexual, queer, and pansexual). Compared with heterosexual women, SMW engage in more hazardous drinking and report more alcohol-related problems. Sexual minority stress (ie, the unique experiences associated with stigmatization and marginalization) has been associated with alcohol use among SMW. Among heterosexuals, relationship factors (eg, partner violence and drinking apart vs together) have also been associated with alcohol use. Negative affect has also been identified as a contributor to alcohol use. To date, most studies examining alcohol use among SMW have used cross-sectional or longitudinal designs. Objective: Project Relate was designed to increase our understanding of alcohol use among young SMW who are at risk for alcohol problems. The primary objectives of this study are to identify daily factors, as well as potential person-level risk and protective factors, which may contribute to alcohol use in SMW. Secondary objectives include examining other physical and mental concerns in this sample (eg, other substance use, eating, physical activity, and stress). Methods: Both partners of a female same-sex couple (aged 18-35 years; n=150 couples) are being enrolled in the study following preliminary screening by a market research firm that specializes in recruiting sexual minority individuals. Web-based surveys are being used to collect information about the primary constructs of interest (daily experiences of alcohol use, sexual minority stress, relationship interactions, and mood) as well as secondary measures of other physical and mental health constructs. Data are collected entirely remotely from women across the United States. Each member of eligible couples completes a baseline survey and then 14 days of daily surveys each morning. Data will be analyzed using multilevel structural equation modeling. Results: To date, 208 women (ie, 104 couples) were successfully screened and enrolled into the study. In total, 164 women have completed the 14-day daily protocol. Compliance with completing the daily diaries has been excellent, with participants on average completing 92\% of the daily diaries. Data collection will be completed in fall 2018, with results published as early as 2019 or 2020. Conclusions: Project Relate is designed to increase our understanding of between- and within-person processes underlying hazardous drinking in understudied, at-risk SMW. The study includes a remote daily diary methodology to provide insight into variables that may be associated with daily hazardous alcohol use. Before the development of programs that address hazardous alcohol use among young SMW, there is a need for better understanding of individual and dyadic variables that contribute to risk in this population. The unique challenges of recruiting and enrolling SMW from across the United States in a daily diary study are discussed. International Registered Report Identifier (IRRID): DERR1-10.2196/11718 ",
doi="10.2196/11718",
url="http://www.researchprotocols.org/2019/2/e11718/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30714946"
}


@Article{info:doi/10.2196/11493,
author="Juniar, Dilfa
and van Ballegooijen, Wouter
and Karyotaki, Eirini
and van Schaik, Anneke
and Passchier, Jan
and Heber, Elena
and Lehr, Dirk
and Sadarjoen, Supardi Sawitri
and Riper, Heleen",
title="Web-Based Stress Management Program for University Students in Indonesia: Systematic Cultural Adaptation and Protocol for a Feasibility Study",
journal="JMIR Res Protoc",
year="2019",
month="Jan",
day="25",
volume="8",
number="1",
pages="e11493",
keywords="internet intervention",
keywords="stress management",
keywords="cultural adaptation",
keywords="feasibility study",
keywords="low and middle income countries (LMICs)",
keywords="university student",
keywords="Indonesia",
abstract="Background: The number of university students experiencing stress is increasing, which often leads to adverse effects such as poor grades, academic probation, and emotional problems. Unfortunately, most of these problems remain untreated because of limited professional resources and fear of stigma. Several Web-based stress management interventions are now available for student populations, but these treatments are not yet available in Indonesia. To make treatment for stress more acceptable in Indonesia, a cultural adaptation process is needed, and part of the process is assessing the feasibility of the adapted intervention. Objective: This paper describes the first two stages of a cultural adaptation process and the protocol of a feasibility study that will assess the acceptability of a culturally adapted stress management intervention for university students in Indonesia. Methods: Focus group discussions with Indonesian university students were held, and input from Indonesian psychologists was gathered for developing the adapted intervention. A single-group feasibility study with a pre-post design will be conducted. We will recruit at minimum 50 university students who have an elevated level of stress (Depression, Anxiety, and Stress Scales--42 stress subscale score ?15), identify themselves as being of Indonesian culture (eg, able to speak Bahasa Indonesia fluently), and are studying at a university in Indonesia. The primary endpoints of this study will be rates of participant satisfaction, system usability, dropout rates, and level of adherence. We will also use qualitative data to assess the adapted intervention more thoroughly. Secondary study endpoints will be quality of life, stress, anxiety, and depression levels. Feasibility parameters (eg, participant satisfaction, system usability, and level of adherence) will be summarized with descriptive statistics. Two-tailed paired within-group t tests will be used to analyze stress, anxiety, depression, and quality of life. Results: The enrollment of pilot study is currently ongoing. First results are expected to be ready for analysis in the second half of 2019. The project was funded as part of a PhD trajectory in 2015 by the Indonesian Endowment Fund for Education. Conclusions: This is one of the first studies to assess the feasibility of a culturally adapted Web-based stress management intervention for university students in Indonesia. Strengths and limitations of the study are discussed. International Registered Report Identifier (IRRID): DERR1-10.2196/11493 ",
doi="10.2196/11493",
url="http://www.researchprotocols.org/2019/1/e11493/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30681970"
}


@Article{info:doi/10.2196/11674,
author="Latulippe, Karine
and Provencher, V{\'e}ronique
and Boivin, Katia
and Vincent, Claude
and Guay, Manon
and Kairy, Dahlia
and Morales, Ernesto
and Pellerin, Marc-Andr{\'e}
and Giroux, Dominique",
title="Using an Electronic Tablet to Assess Patients' Home Environment by Videoconferencing Prior to Hospital Discharge: Protocol for a Mixed-Methods Feasibility and Comparative Study",
journal="JMIR Res Protoc",
year="2019",
month="Jan",
day="14",
volume="8",
number="1",
pages="e11674",
keywords="caregivers",
keywords="feasibility",
keywords="mixed-methods",
keywords="mobile videoconferencing",
keywords="mobile phone",
keywords="occupational therapists",
abstract="Background: Occupational therapists working in hospitals are usually involved in discharge planning to assess patients' safety and autonomy upon returning home. However, their assessment is usually done at the hospital due to organizational and financial constraints. The lack of visual data about the patients' home may thus reduce the appropriateness and applicability of the support recommended upon discharge. Although various technological tools such as mobile devices (mobile health) are promising methods for home-based distance assessment, their application in hospital settings may raise several feasibility issues. To our knowledge, their usefulness and added value compared to standard procedure have not been addressed yet in previous studies. Moreover, several feasibility issues need to be explored. Objective: This paper aims to (1) document the clinical feasibility of using an electronic tablet to assess the patient's home environment by mobile videoconferencing and (2) explore the added value of using mobile videoconferencing, compared to the standard procedure. Methods: A feasibility and comparative study using a mixed-methods (convergent) design is currently undergoing. Six occupational therapists will assess the home environment of their patients in the hospital setting: they will first perform a semistructured interview (a) and then use mobile videoconferencing (b) to compare ``a versus a+b.'' Interviews with occupational therapists and patients and their caregivers will further explore the advantages and disadvantages of mobile videoconferencing. Two valid tools are used (the Canadian Measure of Occupational Performance and the telehealth responsivity questionnaire). Direct and indirect time is also collected. Results: The project was funded in the spring of 2016 and authorized by the ethics committee in February 2017. Enrollment started in April 2017. Five triads (n=4 occupational therapists, n=5 clients, n=5 caregivers) have been recruited until now. The experiment is expected to be completed by April 2019 and analysis of the results by June 2019. Conclusions: Mobile videoconferencing may be a familiar and easy solution for visualizing environmental barriers in the home by caregivers and clinicians, thus providing a promising and inexpensive option to promote a safe return home upon hospital discharge, but clinical feasibility and obstacles to the use of mobile videoconferencing must be understood. International Registered Report Identifier (IRRID): DERR1-10.2196/11674 ",
doi="10.2196/11674",
url="http://www.researchprotocols.org/2019/1/e11674/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31344677"
}


@Article{info:doi/10.2196/12108,
author="Martel, Mary Rhiannon
and Darragh, Louise Margot
and Lawrence, Joanne Aniva
and Shepherd, John Matthew
and Wihongi, Tracey
and Goodyear-Smith, Anne Felicity",
title="YouthCHAT as a Primary Care E-Screening Tool for Mental Health Issues Among Te Tai Tokerau Youth: Protocol for a Co-Design Study",
journal="JMIR Res Protoc",
year="2019",
month="Jan",
day="09",
volume="8",
number="1",
pages="e12108",
keywords="adolescents",
keywords="brief intervention",
keywords="co-design",
keywords="mental health",
keywords="primary health care",
keywords="protocol",
keywords="risk behavior",
keywords="YouthCHAT",
abstract="Background: In New Zealand (NZ), 1 in 4 adolescents is affected by mental health issues (eg, depression and anxiety) and engages in risk behaviors (eg, harmful drinking and substance abuse), with rates among M?ori youth being significantly higher. The majority of NZ secondary school students visit their local primary health care providers (PHPs) at least annually, yet most do not seek help for mental health and risk behavior (MHB) concerns. While youth think it acceptable to discuss sensitive issues during a consultation with their PHPs, unless problems are severe, such conversations are not initiated by PHPs. Early intervention for MHB concerns can prevent long-term health and well-being issues. However, this relies on the early identification of developing problems and youth being offered and accepting help. YouthCHAT is an electronic, multi-item screening tool developed in 2016 to assess MHB concerns among youth. YouthCHAT is completed before a consultation with the PHP, who can access a summary report straight away. A help question allows young people to identify issues that need addressing. A resource pack uses stepped care pathways to guide providers to use appropriate brief interventions. Objective: This study aimed to explore the utility, feasibility, and acceptability of YouthCHAT when tailored for use with youth in primary care settings with large M?ori populations. Objectives of the study are to evaluate the implementation of YouthCHAT in nurse-led youth clinics, school-based clinics, and general practice in Te Tai Tokerau (Northland, NZ); to develop a framework for the scaling up of YouthCHAT across further settings; to assess health provider and youth acceptability of the tool; to improve screening rates for mental health and help-seeking behavior; to enable early identification of emerging problems; and to improve brief intervention delivery. Methods: Using a bicultural mixed-methods co-design approach, 3 phases over a 3-year period will provide an iterative evaluation of the utility, feasibility, and acceptability of YouthCHAT, aiming to create a framework for wider-scale rollout and implementation. Results: Recruitment for the first phase began in September 2018. YouthCHAT was implemented at the first site in October 2018 and is expected to be at a further two sites in late January to early February 2019. The study is due for completion at the end of 2021. Conclusions: YouthCHAT has potential as a user-friendly, time efficient, and culturally safe screening tool for early detection of MHB issues in NZ youth. The resource pack assists the clinician to provide appropriate interventions for emerging and developed youth mental health and lifestyle issues. Involving input from community providers, users, and stakeholders will ensure that modifiable elements of YouthCHAT are tailored to meet the health needs specific to each context and will have a positive influence on future mental, physical, and social outcomes for NZ youth. International Registered Report Identifier (IRRID): PRR1-10.2196/12108 ",
doi="10.2196/12108",
url="http://www.researchprotocols.org/2019/1/e12108/",
url="http://www.ncbi.nlm.nih.gov/pubmed/30626568"
}


@Article{info:doi/10.2196/resprot.9439,
author="Barger, Diana
and Leleux, Olivier
and Conte, Val{\'e}rie
and Sapparrart, Vincent
and Gapillout, Marie
and Crespel, Isabelle
and Erramouspe, Marie
and Delveaux, Sandrine
and Dabis, Francois
and Bonnet, Fabrice",
title="Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study",
journal="JMIR Res Protoc",
year="2018",
month="Jun",
day="07",
volume="7",
number="6",
pages="e147",
keywords="patient-reported outcomes",
keywords="HIV",
keywords="patient-centered care",
keywords="health-related quality of life",
keywords="patient-generated health data",
abstract="Background: Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. Objective: We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Methods: Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history. Results: The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient's perspective (phase 2). Conclusions: As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. Trial Registration: ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps) Registered Report Identifier: RR1-10.2196/9439 ",
doi="10.2196/resprot.9439",
url="http://www.researchprotocols.org/2018/6/e147/"
}


@Article{info:doi/10.2196/10098,
author="Elsbernd, Abbey
and Hjerming, Maiken
and Visler, Camilla
and Hjalgrim, Lyngsie Lisa
and Niemann, Utoft Carsten
and Boisen, Kirsten
and Pappot, Helle",
title="Cocreated Smartphone App to Improve the Quality of Life of Adolescents and Young Adults with Cancer (Kr{\ae}ftv{\ae}rket): Protocol for a Quantitative and Qualitative Evaluation",
journal="JMIR Res Protoc",
year="2018",
month="May",
day="10",
volume="7",
number="5",
pages="e10098",
keywords="AYA",
keywords="adolescent and young adult",
keywords="cancer, mHealth",
keywords="oncology",
keywords="cocreation",
keywords="HRQoL",
keywords="quality of life",
keywords="smartphone",
abstract="Background: Adolescents and young adults with cancer face significant challenges during the course of their medical treatment and recovery from illness. Many adolescents and young adults struggle with long-term complications in the physical, psychosocial, economic, and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of apps on smartphones and tablets. To create a successful mHealth intervention for adolescents and young adults, youth input and feedback is essential. The process of cocreation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for adolescents and young adults with cancer, ``Kr{\ae}ftv{\ae}rket.'' Objective: The objective of this paper is to describe the protocol for the evaluation of the Kr{\ae}ftv{\ae}rket app, a prototype app designed via cocreation, to support and improve health-related quality of life for adolescents and young adults with cancer. Methods: The Kr{\ae}ftv{\ae}rket app has three primary features, (1) a symptom and activity diary, (2) a supportive communication network between app users, and (3) a ``one-stop shop'' information bank with practical information as well as links to patient organizations and other resources. The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 adolescents and young adults aged 15 to 29 years, selected for equal representation amongst age group and treatment status. Patients will be allowed to utilize the app over the course of six weeks and will complete a baseline and follow-up European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) health-related quality of life inventory. In addition, participant focus group interviews will be conducted according to a semistructured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample of 50 adolescents and young adults aged 15-29 years selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. Results: Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. Conclusions: It is the hope that Kr{\ae}ftv{\ae}rket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting adolescents and young adult oncology patients in the digital world. Registered Report Identifier: RR1-10.2196/10098 ",
doi="10.2196/10098",
url="http://www.researchprotocols.org/2018/5/e10098/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29748162"
}


@Article{info:doi/10.2196/resprot.8768,
author="Neville, M. Daniel
and Fogg, Carole
and Brown, P. Thomas
and Jones, L. Thomas
and Lanning, Eleanor
and Bassett, Paul
and Chauhan, J. Anoop",
title="Using the Inflammacheck Device to Measure the Level of Exhaled Breath Condensate Hydrogen Peroxide in Patients With Asthma and Chronic Obstructive Pulmonary Disease (The EXHALE Pilot Study): Protocol for a Cross-Sectional Feasibility Study",
journal="JMIR Res Protoc",
year="2018",
month="Jan",
day="30",
volume="7",
number="1",
pages="e25",
keywords="reexhalation",
keywords="biomarkers",
keywords="medical device",
keywords="asthma",
keywords="COPD",
abstract="Background: Asthma and Chronic Obstructive Pulmonary Disease (COPD) are common conditions that affect over 5 million people in the United Kingdom. These groups of patients suffer significantly from breathlessness and recurrent exacerbations that can be difficult to diagnose and go untreated. A common feature of COPD and asthma is airway inflammation that increases before and during exacerbations. Current methods of assessing airway inflammation can be invasive, difficult to perform, and are often inaccurate. In contrast, measurement of exhaled breath condensate (EBC) hydrogen peroxide (H2O2) is performed during normal tidal breathing and is known to reflect the level of global inflammation in the airways. There is a need for novel tools to diagnose asthma and COPD earlier and to detect increased airway inflammation that precedes an exacerbation. Objective: The aim of this study was to explore the use of a new handheld device (called Inflammacheck) in measuring H2O2 levels in EBC. We will study whether it can measure EBC H2O2 levels consistently and whether it can be used to differentiate asthma and COPD from healthy controls. Methods: We will perform a cross-sectional, feasibility, pilot study of EBC H2O2 levels, as measured by Inflammacheck, and other markers of disease severity and symptom control in patients with asthma and COPD and volunteers with no history of lung disease. Participants will be asked to provide an exhaled breath sample for measurement of their EBC H2O2 using Inflammacheck. The result will be correlated with disease stage, spirometry, fractional exhaled nitric oxide (FeNO), and symptom control scores. Results: This study's recruitment is ongoing; it is anticipated that the results will be available in 2018. Conclusions: The EXhaled Hydrogen peroxide As a marker of Lung diseasE (EXHALE) pilot study will provide an evaluation of a new method of measuring EBC H2O2. It will assess the device's consistency and ability to distinguish airway inflammation in asthma and COPD compared with healthy controls. ",
doi="10.2196/resprot.8768",
url="http://www.researchprotocols.org/2018/1/e25/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29382628"
}


@Article{info:doi/10.2196/resprot.8795,
author="Gulliver, Amelia
and Banfield, Michelle
and Reynolds, Julia
and Miller, Sarah
and Galati, Connie
and Morse, R. Alyssa",
title="A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial",
journal="JMIR Res Protoc",
year="2017",
month="Dec",
day="07",
volume="6",
number="12",
pages="e248",
keywords="peer work",
keywords="tablet app",
keywords="study protocol",
keywords="pilot trial",
keywords="recovery",
keywords="mental illness",
abstract="Background: There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. Objective: This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. Methods: The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. Results: The program will be delivered over a period of approximately 4 months, commencing June 2017. Conclusions: If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers. ",
doi="10.2196/resprot.8795",
url="http://www.researchprotocols.org/2017/12/e248/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29217501"
}


@Article{info:doi/10.2196/resprot.8289,
author="Luu, Mai Thuy
and Xie, Feng Li
and Peckre, Perrine
and Cote, Sylvana
and Karsenti, Thierry
and Walker, Claire-Dominique
and Gosselin, Julie",
title="Web-Based Intervention to Teach Developmentally Supportive Care to Parents of Preterm Infants: Feasibility and Acceptability Study",
journal="JMIR Res Protoc",
year="2017",
month="Nov",
day="30",
volume="6",
number="11",
pages="e236",
keywords="early intervention",
keywords="developmental intervention",
keywords="preterm infants",
keywords="neurodevelopmental outcomes",
keywords="Web-based intervention",
keywords="Internet",
abstract="Background: Preterm birth affects 8\% to 11\% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positive impact on early motor and cognitive development and on parental well-being. However, these programs are often difficult to implement in a real-life setting due to lack of resources. Hence, our multidisciplinary team developed Mieux Agir au Quotidien (MAQ) to teach developmentally supportive care to parents of preterm infants with the goal of improving child development and parental outcomes. Our intervention included 3 in-person workshops that occurred prior to hospital discharge and a Web-based platform with written and videotaped materials that addressed 5 main themes: (1) infant behavioral cues, (2) flexion positioning; (3) oral feeding support, (4) parent-infant interactions, and (5) anticipation of developmental milestones. Objective: This study aimed to test the feasibility and acceptability of the intervention by parents of preterm infants and assess clinical benefits on child neurodevelopment and parental outcomes during the first year of life. Methods: A total of 107 infants born at <30 weeks and admitted to Sainte-Justine Hospital neonatal intensive care unit and their parents were enrolled in a nonrandomized controlled before-and-after interventional study (intervention n=55, comparison n=52). Acceptability of the program was assessed with a user satisfaction questionnaire. When the infants were at 4 months' corrected age, all parents completed questionnaires on infant temperament, parenting stress, sense of competence, and parenting satisfaction. At 12 months' corrected age, neurodevelopmental testing was performed on infants using the Alberta Infant Motor Scale and the Bayley Scales of Infant and Toddler Development, Third Edition. Comparisons between the 2 groups were done using independent t tests, Wilcoxon rank-sum tests, and Fisher exact tests. Results: The majority of parents (43/45) were satisfied with the intervention program and all would recommend MAQ to others. MAQ met their need for evidence-based information that proved useful to support their child development. No difference in parental or child neurodevelopmental outcomes was detected in this pilot study for most outcomes except for higher median scores for parental coercive behaviors in the intervention group, although proportions scoring in the coercive range did not differ. Conclusions: Acceptability of the program was high among parents thus supporting the relevance of such intervention. A larger study using a randomized controlled trial design is needed to better document impact on parent and children and investigate how Web-based technologies can efficiently complement individualized intervention to alleviate the burden on health care resources. ",
doi="10.2196/resprot.8289",
url="http://www.researchprotocols.org/2017/11/e236/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29191797"
}


@Article{info:doi/10.2196/resprot.8059,
author="Buis, R. Lorraine
and Roberson, N. Dana
and Kadri, Reema
and Rockey, G. Nicole
and Plegue, A. Melissa
and Choe, Mi Hae
and Richardson, R. Caroline",
title="Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care: Study Protocol",
journal="JMIR Res Protoc",
year="2017",
month="Oct",
day="10",
volume="6",
number="10",
pages="e193",
keywords="hypertension",
keywords="medication adherence",
keywords="cell phones",
keywords="telemedicine",
abstract="Background: Hypertension (HTN) is a major public health concern in the United States given its wide prevalence, high cost, and poor rates of control. Multiple strategies to counter this growing epidemic have been studied, and home blood pressure (BP) monitoring, mobile health (mHealth) interventions, and referrals to clinical pharmacists for BP management have all shown potential to be effective intervention strategies. Objective: The purpose of this study is to establish feasibility and acceptability of BPTrack, a clinical pharmacist-led mHealth intervention that aims to improve BP control by supporting home BP monitoring and medication adherence among patients with uncontrolled HTN. BPTrack is an intervention that makes home-monitored BP data available to clinical pharmacists for use in HTN management. Secondarily, this study seeks to understand barriers to adoption of this intervention, as well as points of improvement among key stakeholders, so that larger scale dissemination of the intervention may be achieved and more rigorous research can be conducted. Methods: This study is recruiting up to 25 individuals who have poorly controlled HTN from a Family Medicine clinic affiliated with a large Midwestern academic medical center. Patient participants complete a baseline visit, including installation and instructions on how to use BPTrack. Patient participants are then asked to follow the BP monitoring protocol for a period of 12 weeks, and subsequently complete a follow-up visit at the conclusion of the study period. Results: The recruitment period for the pilot study began in November 2016, and data collection is expected to conclude in late-2017. Conclusions: This pilot study seeks to document the feasibility and acceptability of a clinical pharmacist-led mHealth approach to managing HTN within a primary care setting. Through our 12-week pilot study, we expect to lend support for this approach, and lay the foundation for translating this approach into wider-scale implementation. This mHealth intervention seeks to leverage the multidisciplinary care team already in place within primary care, and to improve health outcomes for patients with uncontrolled HTN. Trial Registration: Clinicaltrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 (Archived by WebCite? at http://www.webcitation.org/6u3wTGbe6) ",
doi="10.2196/resprot.8059",
url="http://www.researchprotocols.org/2017/10/e193/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29017994"
}


@Article{info:doi/10.2196/resprot.8397,
author="Craig, L. Shelley
and McInroy, B. Lauren
and D'Souza, A. Sandra
and Austin, Ashley
and McCready, T. Lance
and Eaton, D. Andrew
and Shade, R. Leslie
and Wagaman, Alex M.",
title="Influence of Information and Communication Technologies on the Resilience and Coping of Sexual and Gender Minority Youth in the United States and Canada (Project \#Queery): Mixed Methods Survey",
journal="JMIR Res Protoc",
year="2017",
month="Sep",
day="28",
volume="6",
number="9",
pages="e189",
keywords="mixed methods",
keywords="survey",
keywords="grounded theory",
keywords="sexuality",
keywords="LGBTQ",
keywords="gender",
keywords="sexual orientation",
keywords="gay",
keywords="transgender",
keywords="youth",
keywords="Internet",
keywords="online",
keywords="information and communication technologies",
abstract="Background: Sexual and gender minority youth are a population in peril, exemplified by their disproportionate risk of negative experiences and outcomes. Sexual and gender minority youth may be particularly active users of information and communication technologies (ICTs), and it is important to identify the potential contributions of ICTs to their resilience and well-being. Objective: Our aim was to (1) investigate the use of ICTs by sexual and gender minority youth, (2) identify the ways that ICTs influence the resilience and coping of sexual and gender minority youth, focusing on promotion of well-being through self-guided support-seeking (particularly using mobile devices), (3) develop a contextually relevant theoretical conceptualization of resilience incorporating minority stress and ecological approaches, (4) generate best practices and materials that are accessible to multiple interested groups, and (5) identify whether video narratives are a viable alternative to collect qualitative responses in Web-based surveys for youth. Methods: Mixed methods, cross-sectional data (N=6309) were collected via a Web-based survey from across the United States and Canada from March-July 2016. The sample was generated using a multipronged, targeted recruitment approach using Web-based strategies and consists of self-identified English-speaking sexual and gender minority youth aged 14-29 with technological literacy sufficient to complete the Web-based survey. The survey was divided into eight sections: (1) essential demographics, (2) ICT usage, (3) health and mental health, (4) coping and resilience, (5) sexual and gender minority youth identities and engagement, (6) fandom communities, (7) nonessential demographics, and (8) a video submission (optional, n=108). The option of a 3-5 minute video submission represents a new research innovation in Web-based survey research. Results: Data collection is complete (N=6309), and analyses are ongoing. Proposed analyses include (1) structural equation modeling of quantitative data, (2) grounded theory analysis of qualitative data, and (3) an integrative, mixed methods analysis using a data transformation design. Theoretical and methodological triangulation of analyses integrates an interwoven pattern of results into a comprehensive picture of a phenomenon. Results will be reported in 2017 and 2018. Conclusions: This research study will provide critical insights into the emerging use of ICTs by sexual and gender minority youth and identify intervention strategies to improve their well-being and reduce risks encountered by this vulnerable population. Implications for practice, research, and knowledge translation are provided. ",
doi="10.2196/resprot.8397",
url="http://www.researchprotocols.org/2017/9/e189/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28958984"
}


@Article{info:doi/10.2196/resprot.7667,
author="Nanton, Veronica
and Appleton, Rebecca
and Dale, Jeremy
and Roscoe, Julia
and Hamborg, Thomas
and Ahmedzai, H. Sam
and Arvanitis, N. Theodoros
and Badger, Douglas
and James, Nicholas
and Mendelsohn, Richard
and Khan, Omar
and Parashar, Deepak
and Patel, Prashant",
title="Integrated Care in Prostate Cancer (ICARE-P): Nonrandomized Controlled Feasibility Study of Online Holistic Needs Assessment, Linking the Patient and the Health Care Team",
journal="JMIR Res Protoc",
year="2017",
month="Jul",
day="28",
volume="6",
number="7",
pages="e147",
keywords="Internet",
keywords="prostate cancer",
keywords="holistic needs assessment",
keywords="integrated care",
abstract="Background: The potential of technology to aid integration of care delivery systems is being explored in a range of contexts across a variety of conditions in the United Kingdom. Prostate cancer is the most common cancer in UK men. With a 10-year survival rate of 84\%, there is a need to explore innovative methods of care that are integrated between primary health care providers and specialist teams in order to address long-term consequences of the disease and its treatment as well as to provide continued monitoring for recurrence. Objective: Our aim was to test the feasibility of a randomized controlled trial to compare a model of prostate cancer continuing and follow-up care integration, underpinned by digital technology, with usual care in terms of clinical and cost-effectiveness, patient-reported outcomes, and experience. Methods: A first phase of the study has included development of an online adaptive prostate specific Holistic Needs Assessment system (HNA), training for primary care-based nurses, training of an IT peer supporter, and interviews with health care professionals and men with prostate cancer to explore views of their care, experience of technology, and views of the proposed intervention. In Phase 2, men in the intervention arm will complete the HNA at home to help identify and articulate concerns and share them with their health care professionals, in both primary and specialist care. Participants in the control arm will receive usual care. Outcomes including quality of life and well-being, prostate-specific concerns, and patient enablement will be measured 3 times over a 9-month period. Results: Findings from phase 1 indicated strong support for the intervention among men, including those who had had little experience of digital technology. Men expressed a range of views on ways that the online system might be used within a clinical pathway. Health care professionals gave valuable feedback on how the output of the assessment might be presented to encourage engagement and uptake by clinical teams. Recruitment to the second phase of the study, the feasibility trial, commenced March 2017. Conclusions: To our knowledge, this study is the first in the United Kingdom to trial an online holistic needs assessment for men with prostate cancer, with data shared between patients and primary and secondary care providers. This study addresses recommendations in recent policy documents promoting the importance of data sharing and enhanced communication between care providers as a basis for care integration. We anticipate that this model of care will ultimately provide important benefits for both patients and the National Health Service. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 31380482; http://www.isrctn.com/ISRCTN31380482 (Archived by WebCite at http://www.webcitation.org/6s8I42u5N) ",
doi="10.2196/resprot.7667",
url="http://www.researchprotocols.org/2017/7/e147/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28754653"
}


@Article{info:doi/10.2196/resprot.6636,
author="Roberts, Claire
and Jones, L. Thomas
and Gunatilake, Samal
and Storrar, Will
and Elliott, Scott
and Glaysher, Sharon
and Green, Ben
and Rule, Steven
and Fogg, Carole
and Dewey, Ann
and Auton, A. Kevin
and Chauhan, J. Anoop",
title="The SENSOR Study: Protocol for a Mixed-Methods Study of Self-Management Checks to Predict Exacerbations of Pseudomonas Aeruginosa in Patients with Long-Term Respiratory Conditions",
journal="JMIR Res Protoc",
year="2017",
month="May",
day="19",
volume="6",
number="5",
pages="e89",
keywords="COPD",
keywords="bronchiectasis",
keywords="pseudomonas",
keywords="self-management",
abstract="Background: There are an estimated three million people in the United Kingdom with chronic obstructive pulmonary disease (COPD), and the incidence of bronchiectasis is estimated at around 0.1\% but is more common in COPD and severe asthma. Both COPD and bronchiectasis are characterized by exacerbations in which bacteria play a central role. Pseudomonas aeruginosa is isolated from sputum samples from 4\% to 15\% of adults with COPD and is more likely to be isolated from patients with severe disease. Earlier detection of exacerbations may improve morbidity and mortality by expediting treatment. Aseptika Ltd has developed a system for patients to self-monitor important physiological measurements including levels of physical activity, peak flow, forced expiratory volume (FEV1), and biomarkers for P aeruginosa in sputum. Objective: We aim to test this system in 20 participants with P aeruginosa colonization and 10 controls with Haemophilus influenzae. Methods: We plan to recruit 30 adult participants with COPD or non-CF bronchiectasis who have cultured P aeruginosa or H influenzae during an exacerbation in the last 6 months. They must produce sputum on most days and should have been stable for 4 weeks prior to entry. Daily data collected will include symptoms, health care usage, medication, weight, FEV1, physical activity level, blood pressure, oxygen saturation, and temperature. Sputum and urine samples will be provided daily. These data will be analyzed to assess predictive value in detecting upcoming exacerbations. Qualitative data will be gathered through self-administered questionnaires and semistructured interviews to gather information on participant coping and their use of the technology involved. Results: Recruitment has been completed and results from the study should be available at the end of 2017. Conclusions: The SENSOR study aims to test a home-monitoring system in people with chronic airway infection and is currently underway. ",
doi="10.2196/resprot.6636",
url="http://www.researchprotocols.org/2017/5/e89/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28526665"
}


@Article{info:doi/10.2196/resprot.6993,
author="Gimbel, Ronald
and Shi, Lu
and Williams, E. Joel
and Dye, J. Cheryl
and Chen, Liwei
and Crawford, Paul
and Shry, A. Eric
and Griffin, F. Sarah
and Jones, O. Karyn
and Sherrill, W. Windsor
and Truong, Khoa
and Little, R. Jeanette
and Edwards, W. Karen
and Hing, Marie
and Moss, B. Jennie",
title="Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol",
journal="JMIR Res Protoc",
year="2017",
month="Mar",
day="06",
volume="6",
number="3",
pages="e38",
keywords="mHealth",
keywords="diabetes mellitus",
keywords="patient activation",
keywords="patient-centered medical home",
keywords="patient centered care",
keywords="eHealth",
keywords="health information",
abstract="Background: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. Objective: We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. Methods: This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. Results: We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. Conclusions: The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. Trial Registration: ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei) ",
doi="10.2196/resprot.6993",
url="http://www.researchprotocols.org/2017/3/e38/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28264792"
}


@Article{info:doi/10.2196/resprot.6314,
author="Ose, Dominik
and Kunz, Aline
and Pohlmann, Sabrina
and Hofmann, Helene
and Qreini, Markus
and Krisam, Johannes
and Uhlmann, Lorenz
and Jacke, Christian
and Winkler, C. Eva
and Salize, Hans-Joachim
and Szecsenyi, Joachim",
title="A Personal Electronic Health Record: Study Protocol of a Feasibility Study on Implementation in a Real-World Health Care Setting",
journal="JMIR Res Protoc",
year="2017",
month="Mar",
day="02",
volume="6",
number="3",
pages="e33",
keywords="self-efficacy",
keywords="personal electronic health record",
keywords="colorectal cancer",
keywords="chronic care",
keywords="interprofessional collaboration",
keywords="telemedicine",
keywords="feasibility studies",
abstract="Background: A significant potential for patient empowerment is seen in concepts aiming to give patients access to their personal health information (PHI) and to share this PHI across different care settings and health systems. Personal health records (PHRs) and the availability of information through health information exchanges are considered to be key components of effective and efficient health care. With tethered PHRs, as often used in the United States, patients' opportunities to manage their PHI are strongly restricted. Therefore, within the INFOPAT (information technology for patient oriented care) project (2012-2016) in Germany, funded by the Federal Ministry of Education and Research (BMBF), the development of a patient-controlled ``personal electronic health record'' (PEPA) was based on user requirements right from the beginning. Objective: The overall objective of the study is to implement and evaluate a PEPA prototype for patients with colorectal cancer who are treated at the National Center for Tumor Diseases in Heidelberg. To achieve this aim, this study has 2 parts: a pre-implementation study (phase 1) and an implementation study (phase 2). The pre-implementation study will include a usability evaluation of the PEPA approach and the consideration of organizational preconditions for the implementation. With the implementation study, we will evaluate the process of implementation (eg, barriers or facilitators), the need for organizational change (eg, processes of communication), and the impact on outcomes (eg, self-efficacy, involvement in care). Methods: The pre-implementation study is based on a mixed methods approach and comprises qualitative and quantitative element according to our research aim. We will use a think-aloud method for the usability analysis. Additionally, participants will be asked to evaluate their overall satisfaction based on a standardized questionnaire, the System Usability Scale. For the analysis of preconditions, we will conduct semistructured personal interviews with, for example, patients, medical assistants, and physicians. Within the implementation study the outcome evaluation is planned as a prospective, 3-month, open-label ``before and after'' trial. Additionally, for the analysis of processes and the need for organizational change, we will conduct interviews with the participants (eg, patients, general practitioners, physicians) of the before and after trial. Results: This project is part of the INFOPAT project, which is funded (2012-2016) by the Federal Ministry of Education and Research (BMBF). The enrolment was completed in July 2016. Data analysis is currently under way and the first results are expected to be submitted for publication at end of 2017. Conclusions: Existing approaches of PHRs aim to give patients access to their treatment data. With the PEPA approach and this study, we go a step further: patients have access to their PHI and they can give other persons (eg, their general practitioner) access. With this approach, new possibilities for professional collaboration and the engagement of patients can arise. ",
doi="10.2196/resprot.6314",
url="http://www.researchprotocols.org/2017/3/e33/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28254735"
}


@Article{info:doi/10.2196/resprot.6819,
author="Fernandes-Taylor, Sara
and Gunter, L. Rebecca
and Bennett, M. Kyla
and Awoyinka, Lola
and Rahman, Shahrose
and Greenberg, C. Caprice
and Kent, Craig K.",
title="Feasibility of Implementing a Patient-Centered Postoperative Wound Monitoring Program Using Smartphone Images: A Pilot Protocol",
journal="JMIR Res Protoc",
year="2017",
month="Feb",
day="22",
volume="6",
number="2",
pages="e26",
keywords="telemedicine",
keywords="smartphone",
keywords="surgical site infection",
keywords="transitional care",
keywords="feasibility study",
keywords="clinical research protocol",
abstract="Background: Surgical site infections (SSI) represent a significant public health problem as the most common nosocomial infection and a leading cause of unplanned hospital readmissions among surgical patients. Many develop following hospital discharge and often go unrecognized by patients. Telemedicine offers the opportunity to leverage the mobile technology to remotely monitor wound recovery in the transitional period between hospital discharge and routine clinic follow-up. However, many existing telemedicine platforms are episodic, replacing routine follow-up, rather than equipped for continued monitoring; they include only low-risk patient populations and those who already have access to and comfort with the necessary technology; and transmit no visual information. Objective: Drawing upon the Coleman model for care transitions and the Proctor model for implementation, we propose a protocol of postoperative wound monitoring using smartphone digital images. In this study, we will establish the feasibility of such a program, both for patients and for the clinical care team. Methods: We will recruit 40 patients or patient/caregiver pairs from our inpatient vascular surgery service. Eligible patients will be English-speaking, 18 years of age or older, and have an incision at least 3 cm in length. Participants will receive a training session, during which they will learn to use the device and the wound monitoring smartphone app. Following hospital discharge, they will submit digital images of their wound and responses to a survey about their recovery for 14 days. Experienced health care providers on the vascular surgery inpatient service will review transmitted data daily and contact patients for any concerning findings. Results: Primary outcomes will include participant adherence to the protocol, time required for providers to review submissions, time from submission to provider review, and participant satisfaction. Secondary outcomes will include SSI detection and hospital readmission. Conclusions: Health systems are increasingly dedicating efforts to transitional care improvement programs. This feasibility trial will confirm whether patients and their caregivers can learn to use a postdischarge wound monitoring smartphone app and will assess patient and provider satisfaction. This protocol will provide preliminary evidence for a shift in the delivery of postdischarge care in a patient-centered and cost-effective manner. Trial Registration: Clinicaltrials.gov NCT02735525; https://clinicaltrials.gov/ct2/show/NCT02735525 (Archived by WebCite at http://www.webcitation.org/6oIvN4Mab) ",
doi="10.2196/resprot.6819",
url="http://www.researchprotocols.org/2017/2/e26/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28228369"
}


@Article{info:doi/10.2196/resprot.6886,
author="Simmons, G. Rebecca
and Shattuck, C. Dominick
and Jennings, H. Victoria",
title="Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol",
journal="JMIR Res Protoc",
year="2017",
month="Jan",
day="18",
volume="6",
number="1",
pages="e5",
keywords="fertility",
keywords="fertility awareness",
keywords="family planning",
keywords="contraception",
keywords="natural family planning",
keywords="reproductive health",
keywords="mHealth",
keywords="mobile health apps",
keywords="study protocol",
abstract="Background: Some 222 million women worldwide have unmet needs for contraception; they want to avoid pregnancy, but are not using a contraceptive method, primarily because of concerns about side effects associated with most available methods. Expanding contraceptive options---particularly fertility awareness options that provide women with information about which days during their menstrual cycles they are likely to become pregnant if they have unprotected intercourse---has the potential to reduce unmet need. Making these methods available to women through their mobile phones can facilitate access. Indeed, many fertility awareness applications have been developed for smartphones, some of which are digital platforms for existing methods, requiring women to enter information about fertility signs such as basal body temperature and cervical secretions. Others are algorithms based on (unexplained) calculations of the fertile period of the menstrual cycle. Considering particularly this latter (largely untested) group, it is critical that these apps be subject to the same rigorous research as other contraceptive methods. Dynamic Optimal Timing, available via the Dot app as a free download for iPhone and Android devices, is one such method and the only one that has published the algorithm that forms its basis. It combines historical cycle data with a woman's own personal cycle history, continuing to accrue this information over time to identify her fertile period. While Dot has a theoretical failure rate of only 3 in 100 for preventing pregnancy with perfect use, its effectiveness in typical use has yet to be determined. Objective: The study objective is to assess both perfect and typical use to determine the efficacy of the Dot app for pregnancy prevention. Methods: To determine actual use efficacy, the Institute for Reproductive Health is partnering with Cycle Technologies, which developed the Dot app, to conduct a prospective efficacy trial, following 1200 women over the course of 13 menstrual cycles to assess pregnancy status over time. This paper outlines the protocol for this efficacy trial, following the Standard Protocol Items: Recommendations for Intervention Trials checklist, to provide an overview of the rationale, methodology, and analysis plan. Participants will be asked to provide daily sexual history data and periodically answer surveys administered through a call center or directly on their phone. Results: Funding for the study was provided in 2013 under the United States Agency for International Development Fertility Awareness for Community Transformation project. Recruitment for the study will begin in January of 2017. The study is expected to last approximately 18 months, depending on recruitment. Findings on the study's primary outcomes are expected to be finalized by September 2018. Conclusions: Reproducibility and transparency, important aspects of all research, are particularly critical in developing new approaches to research design. This protocol outlines the first study to prospectively test both the efficacy (correct use) and effectiveness (actual use) of a pregnancy prevention app. This protocol and the processes it describes reflect the dynamic integration of mobile technologies, a call center, and Health Insurance Portability and Accountability Act--compliant study procedures. Future fertility app studies can build on our approaches to develop methodologies that can contribute to the evidence base around app-based methods of contraception. ClinicalTrial: ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76) ",
doi="10.2196/resprot.6886",
url="http://www.researchprotocols.org/2017/1/e5/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28100441"
}


@Article{info:doi/10.2196/resprot.6024,
author="Gonzalez-Rivera, Milagros
and Picornell, C. Antoni
and Alvarez, L. Enrique
and Martin, Miguel",
title="A Cross-Sectional Comparison of Druggable Mutations in Primary Tumors, Metastatic Tissue, Circulating Tumor Cells, and Cell-Free Circulating DNA in Patients with Metastatic Breast Cancer: The MIRROR Study Protocol",
journal="JMIR Res Protoc",
year="2016",
month="Aug",
day="16",
volume="5",
number="3",
pages="e167",
keywords="breast neoplasm",
keywords="drug therapy",
keywords="genetics",
keywords="molecular targeted therapy",
keywords="sequence analysis.",
abstract="Background: Characterization of the driver mutations in an individual metastatic breast cancer (MBC) patient is critical to selecting effective targeted therapies. Currently, it is believed that the limited efficacy of many targeted drugs may be due to the expansion of drug resistant clones with different genotypes that were already present in the primary tumor. Identifying the genomic alterations of these clones, and introducing combined or sequential targeted drug regimens, could lead to a significant increase in the efficacy of currently available targeted therapies. Objective: The primary objective of this study is to assess the concordance/discordance of mutations between the primary tumor and metastatic tissue in MBC patients. Secondary objectives include comparing the genomic profiles of circulating tumor cells (CTCs) and circulating free DNA (cfDNA) from peripheral blood with those of the primary tumor and metastatic tissue for each patient, evaluating these mutations in the signaling pathways that are relevant to the disease, and testing the feasibility of introducing liquid biopsy as a translational laboratory tool in clinical practice. Methods: The multicenter, transversal, observational MIRROR study is currently ongoing in three participating hospitals. All consecutive patients with MBC confirmed by radiologic findings will be screened for eligibility, either at first relapse or if tumor regrowth occurs while on treatment for metastatic disease. Results: Patient recruitment is currently ongoing. To date, 41 patients have a complete set of tissue samples available (plasma, CTCs, and formalin-fixed, paraffin-embedded primary tumor and metastatic tumor). However, none of these samples have undergone nucleic acids extraction or targeted deep sequencing. Conclusions: The results of this study may have a significant influence on the practical management of patients with MBC, and may provide clues to clinicians that lead towards a better stratification of patients, resulting in more selective and less toxic treatments. Additionally, if genomic mutations found in metastatic tissues are similar to those detected in CTCs and/or cfDNA, liquid biopsies could prove to be a more convenient, non-invasive, and easily accessible source of genomic material for the analysis of mutations and other genomic aberrations in MBC. Trial Registration: ClinicalTrials.gov NCT02626039; https://clinicaltrials.gov/ct2/show/NCT02626039 (Archived by WebCite at http://www.webcitation.org/6jlneVyoz) ",
doi="10.2196/resprot.6024",
url="http://www.researchprotocols.org/2016/3/e167/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27531554"
}


@Article{info:doi/10.2196/resprot.5543,
author="Young, Amber
and Tordoff, June
and Dovey, Susan
and Reith, David
and Lloyd, Hywel
and Tilyard, Murray
and Smith, Alesha",
title="Using an Electronic Decision Support Tool to Reduce Inappropriate Polypharmacy and Optimize Medicines: Rationale and Methods",
journal="JMIR Res Protoc",
year="2016",
month="Jun",
day="10",
volume="5",
number="2",
pages="e105",
keywords="polypharmacy",
keywords="decision support systems",
keywords="clinical, drug-related side effects and adverse reactions",
keywords="drug interactions",
keywords="primary health care",
keywords="inappropriate prescribing",
keywords="medication therapy management",
abstract="Background: Polypharmacy and inappropriate continuation of medicines can lead to a significant risk of adverse drug events and drug interactions with patient harm and escalating health care costs as a result. Thorough review of patients' medications focusing on the need for each drug can reduce the potential for harm. Limitations in performing effective medicine reviews in practice include consultation time constraints and funding for pharmacy services. We will aim to overcome these problems by designing an automatic electronic decision support tool (the medicines optimization/review and evaluation (MORE) module) that is embedded in general practice electronic records systems. The tool will focus on medicines optimization and reducing polypharmacy to aid prescribers in reviewing medicines and improve patient outcomes. Objective: The objectives of this study are: (1) to develop an electronic decision support tool to assist prescribers in performing clinical medication reviews with a particular focus on patients experiencing multimorbidity and polypharmacy, and (2) evaluate and assess the use of the electronic decision support tool, providing pilot data on its usefulness in supporting prescribers during consultations with patients. Methods: The first three study phases involve development of clinical rules outlining clinical interventions and the creation and validation of the MORE decision support tool. Phase four is a community-based, single-blind, prospective, 6-month controlled trial involving two interventions and two control general practices, matched for practice demographics. We will be measuring the number of times prescribers engage with the tool, total number of interventions suggested by the tool, and total number of times prescribers change medicines in response to recommendations. There will also be prospective follow-up of patients in the intervention group to examine whether changes to medications are upheld, and to determine the number of hospitalizations or emergency department visits within 6 months of a medicine intervention. Comparisons between control and intervention practices will measure the changes in proportions of patients with polypharmacy and inappropriately prescribed medicines before and after the introduction of the electronic decision support tool, proportions of patients receiving appropriate treatment in each practice, and changed, maintained, or improved health status, hospitalizations, and deaths in the study year. Initiation rates of inappropriately prescribed medicines will be measured as a secondary outcome. As well as external assessment of the extent of use and application of the tool, prescribers will receive monthly practice progress reports detailing the proportion of their patients experiencing polypharmacy and taking inappropriately prescribed medicines identified for review. Results: Phase one has now been completed and the decision support tool is under development. Final data analysis is expected to be available in December 2016. Conclusions: This study will establish whether the MORE decision support tool stands up to real world conditions and promotes changes in prescribing practice. ",
doi="10.2196/resprot.5543",
url="http://www.researchprotocols.org/2016/2/e105/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27288200"
}


@Article{info:doi/10.2196/resprot.5092,
author="Tiro, A. Jasmin
and Lee, Craddock Simon
and Marks, G. Emily
and Persaud, Donna
and Skinner, Sugg Celette
and Street, L. Richard
and Wiebe, J. Deborah
and Farrell, David
and Bishop, Pechero Wendy
and Fuller, Sobha
and Baldwin, S. Austin",
title="Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study",
journal="JMIR Res Protoc",
year="2016",
month="Jan",
day="29",
volume="5",
number="1",
pages="e19",
keywords="adolescents",
keywords="intervention development",
keywords="HPV vaccination",
keywords="self-persuasion",
abstract="Background: Human papillomavirus (HPV)-related cancers are a significant burden on the US health care system that can be prevented through adolescent HPV vaccination. Despite guidelines recommending vaccination, coverage among US adolescents is suboptimal particularly among underserved patients (uninsured, low income, racial, and ethnic minorities) seen in safety-net health care settings.  Many parents are ambivalent about the vaccine and delay making a decision or talking with a provider about it. Self-persuasion---generating one's own arguments for a health behavior---may be particularly effective for parents who are undecided or not motivated to make a vaccine decision. Objective: Through a 3-stage mixed-methods protocol, we will identify an optimal and feasible self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. Methods: In Stage 1, we will define content for a tablet-based self-persuasion app by characterizing (1) parents' self-generated arguments through cognitive interviews conducted with parents (n=50) of patients and (2) parent-provider HPV vaccine discussions through audio recordings of clinic visits (n=50). In Stage 2, we will compare the effects of the four self-persuasion intervention conditions that vary by cognitive processing level (parents verbalize vs listen to arguments) and choice of argument topics (parents choose vs are assigned topics) on parental vaccine intentions in a 2 {\texttimes} 2 factorial design randomized controlled trial (n=160). This proof-of-concept trial design will identify which intervention condition is optimal by quantitatively examining basic self-persuasion mechanisms (cognitive processing and choice) and qualitatively exploring parent experiences with intervention tasks. In Stage 3, we will conduct a pilot trial (n=90) in the safety-net clinics to assess feasibility of the optimal intervention condition identified in Stage 2. We will also assess its impact on parent-provider discussions. Results: This paper describes the study protocol and activities to date. Currently, we have developed the initial prototype of the tablet app for English- and Spanish-speaking populations, and completed Stage 1 data collection. Conclusions: Our systematic collaboration between basic and applied behavioral scientists accelerates translation of promising basic psychological research into innovative interventions suitable for underserved, safety-net populations. At project's end, we plan to have a feasible and acceptable self-persuasion intervention that can affect key cancer disparities in the United States through prevention of HPV-related cancers. Trial Registration: ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT02537756 and http://clinicaltrials.gov/ct2/show/NCT02535845 (Archived by WebCite at http://www.webcitation.org/6e5XcOGXz and http://www.webcitation.org/6e5XfHoic, respectively). ",
doi="10.2196/resprot.5092",
url="http://www.researchprotocols.org/2016/1/e19/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26825137"
}


@Article{info:doi/10.2196/resprot.4802,
author="Mahler, A. Simon
and Burke, L. Gregory
and Duncan, W. Pamela
and Case, D. Larry
and Herrington, M. David
and Riley, F. Robert
and Wells, J. Brian
and Hiestand, C. Brian
and Miller, D. Chadwick",
title="HEART Pathway Accelerated Diagnostic Protocol Implementation: Prospective Pre-Post Interrupted Time Series Design and Methods",
journal="JMIR Res Protoc",
year="2016",
month="Jan",
day="22",
volume="5",
number="1",
pages="e10",
keywords="chest pain",
keywords="decision support technique",
keywords="interrupted time series analysis",
keywords="acute coronary syndrome",
keywords="implementation methods",
keywords="electronic medical records",
abstract="Background: Most patients presenting to US Emergency Departments (ED) with chest pain are hospitalized for comprehensive testing. These evaluations cost the US health system >\$10 billion annually, but have a diagnostic yield for acute coronary syndrome (ACS) of <10\%. The history/ECG/age/risk factors/troponin (HEART) Pathway is an accelerated diagnostic protocol (ADP), designed to improve care for patients with acute chest pain by identifying patients for early ED discharge. Prior efficacy studies demonstrate that the HEART Pathway safely reduces cardiac testing, while maintaining an acceptably low adverse event rate. Objective: The purpose of this study is to determine the effectiveness of HEART Pathway ADP implementation within a health system. Methods: This controlled before-after study will accrue adult patients with acute chest pain, but without ST-segment elevation myocardial infarction on electrocardiogram for two years and is expected to include approximately 10,000 patients. Outcomes measures include hospitalization rate, objective cardiac testing rates (stress testing and angiography), length of stay, and rates of recurrent cardiac care for participants. Results: In pilot data, the HEART Pathway decreased hospitalizations by 21\%, decreased hospital length (median of 12 hour reduction), without increasing adverse events or recurrent care. At the writing of this paper, data has been collected on >5000 patient encounters. The HEART Pathway has been fully integrated into health system electronic medical records, providing real-time decision support to our providers. Conclusions: We hypothesize that the HEART Pathway will safely reduce healthcare utilization. This study could provide a model for delivering high-value care to the 8-10 million US ED patients with acute chest pain each year. ClinicalTrial: Clinicaltrials.gov NCT02056964; https://clinicaltrials.gov/ct2/show/NCT02056964 (Archived by WebCite at  http://www.webcitation.org/6ccajsgyu) ",
doi="10.2196/resprot.4802",
url="http://www.researchprotocols.org/2016/1/e10/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26800789"
}


@Article{info:doi/10.2196/resprot.4948,
author="Lingner, Heidrun
and Gro{\ss}hennig, Anika
and Flunkert, Kathrin
and Buhr-Schinner, Heike
and Heitmann, Rolf
and T{\"o}nnesmann, Ulrich
and van der Meyden, Jochen
and Schultz, Konrad",
title="ProKaSaRe Study Protocol: A Prospective Multicenter Study of Pulmonary Rehabilitation of Patients With Sarcoidosis",
journal="JMIR Res Protoc",
year="2015",
month="Dec",
day="04",
volume="4",
number="4",
pages="e134",
keywords="sarcoidosis",
keywords="rehabilitation",
keywords="quality of life",
keywords="fatigue",
abstract="Background: Available data assessing the efficacy of pulmonary rehabilitation for patients with chronic sarcoidosis are scant; for Germany, there are none at all. Objective: To gain information about the benefit of in-house pulmonary rehabilitation for patients with chronic sarcoidosis and for the health care system, we intend to collect data in a prospective multicenter ``real-life'' cohort trial. Methods: ProKaSaRe (Prospektive Katamnesestudie Sarkoidose in der pneumologischen Rehabilitation) [Prospective Catamnesis Study of Sarcoidosis in Pulmonary Rehabilitation] will assess a multimodal 3-week inpatient pulmonary rehabilitation program for adult patients with chronic sarcoidosis over a 1-year follow-up time. Defined specific clinical measurements and tests will be performed at the beginning and the end of the rehabilitation. In addition, questionnaires concerning health-related quality of life and the patients' symptoms will be provided to all patients. Inclusion criteria will be referral to one of the 6 participating pulmonary rehabilitation clinics in Germany for sarcoidosis and age between 18 and 80 years. Patients will only be excluded for a lack of German language skills or the inability to understand and complete the study questionnaires. To rule out seasonal influences, the recruitment will take place over a period of 1 year. In total, at least 121 patients are planned to be included. A descriptive statistical analysis of the data will be performed, including multivariate analyses. The primary outcomes are specific health-related quality of life (St George's Respiratory Questionnaire) and exercise capacity (6-minute walk test). The secondary outcomes are several routine lung function and laboratory parameters, dyspnea scores and blood gas analysis at rest and during exercise, changes in fatigue, psychological burden, and generic health-related quality of life (36-item Short Form Health Survey). Results: Funding was obtained on October 12, 2010; enrollment began on January 15, 2011 and was completed by January 14, 2012. Results are anticipated late summer 2015. Conclusions: Due to the large number of participants, we expect to obtain representative findings concerning the effectiveness of pulmonary rehabilitation for patients with sarcoidosis and to provide a dataset of assessed objective and subjective short- and long-term changes due to pulmonary rehabilitation. The results should form the basis for the planning of a randomized controlled trial. Trial Registration: German Clinical Trials Register: DRKS00000560; https://drks-neu.uniklinik-freiburg.de/ drks\_web/navigate.do?navigationId=trial.HTML\&TRIAL\_ID=DRKS00000560 (Archived by WebCite? at http://www.webcitation.org/6dKb5X87R) ",
doi="10.2196/resprot.4948",
url="http://www.researchprotocols.org/2015/4/e134/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26679102"
}


@Article{info:doi/10.2196/resprot.4039,
author="Lau, Kwan Yan
and Caverly, J. Tanner
and Cherng, T. Sarah
and Cao, Pianpian
and West, Mindy
and Arenberg, Douglas
and Meza, Rafael",
title="Development and Validation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening Using Mixed Methods: A Study Protocol",
journal="JMIR Res Protoc",
year="2014",
month="Dec",
day="19",
volume="3",
number="4",
pages="e78",
keywords="informed decision-making",
keywords="lung cancer screening",
keywords="patient decision aid",
keywords="patient education",
abstract="Background: The National Lung Screening Trial demonstrated that low-dose computed tomography (LDCT) screening could be an effective way to reduce lung cancer mortality. Informed decision-making in the context of lung cancer screening requires that potential screening subjects accurately recognize their own lung cancer risk, as well as the harms and benefits associated with screening, while taking into account their personal values and preferences. Objective: Our objective is to develop a Web-based decision aid in accordance with the qualifying and certification criteria in the International Patient Decision Aid Standards instrument version 4.0 that will assist patients in making informed decisions with regard to lung cancer screening. Methods: In ``alpha'' testing, a prototype of the decision aid was tested for usability with 10 potential screening participants in focus groups. Feedback was also sought from public health and health risk communication experts external to the study. Following that, improvements to the prototype were made accordingly, and ``beta'' testing was done in the form of a quasi-experimental design---a before-after study---with a group of 60 participants. Outcomes tested were knowledge, risk perception of lung cancer and lung cancer screening, decisional conflict, and acceptability of the decision aid as determined by means of a self-administered electronic survey. Focus groups of a subsample of survey participants will be conducted to gain further insight into usability issues. Results: Alpha testing is completed. Beta testing is currently being carried out. As of 2014 December 7, 60 participants had completed the before-after study. We expect to have results by 2015 January 31. Qualitative data collection and analysis are expected to be completed by 2015 May 31. Conclusions: We hypothesize that this Web-based, interactive decision aid containing personalized, graphical, and contextual information on the benefits and harms of LDCT screening will increase knowledge, reduce decisional conflict, and improve concordance between patient preferences and the current US Preventive Services Task Force's screening guidelines. ",
doi="10.2196/resprot.4039",
url="http://www.researchprotocols.org/2014/4/e78/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25532218"
}


@Article{info:doi/10.2196/resprot.3045,
author="Johnson, Constance
and Feinglos, Mark
and Pereira, Katherine
and Hassell, Nancy
and Blascovich, Jim
and Nicollerat, Janet
and Beresford, F. Henry
and Levy, Janet
and Vorderstrasse, Allison",
title="Feasibility and Preliminary Effects of a Virtual Environment for Adults With Type 2 Diabetes: Pilot Study",
journal="JMIR Res Protoc",
year="2014",
month="Apr",
day="08",
volume="3",
number="2",
pages="e23",
keywords="diabetes mellitus, type 2",
keywords="self-care",
keywords="user-computer interface",
keywords="virtual environments software",
keywords="consumer health information",
keywords="health communication",
abstract="Background: Innovative interventions that empower patients in diabetes self-management (DSM) are needed to provide accessible, sustainable, cost-effective patient education and support that surpass current noninteractive interventions. Skills acquired in digital virtual environments (VEs) affect behaviors in the physical world. Some VEs are programmed as real-time three-dimensional representations of various settings via the Internet. For this research, a theoretically grounded VE that facilitates DSM was developed and pilot tested. It offered weekly synchronous DSM education classes, group meetings, and social networking in a community in which participants practiced real world skills such as grocery shopping, exercising, and dining out, allowing for interactive knowledge application. The VE was available 24/7 on the Internet, minimizing access barriers. Objective: The objective of this study was to evaluate the feasibility and efficacy of participation in a VE for DSM education and support. Methods: This study utilized a single group, pre-mid-post measure design. At 0, 3, and 6 months, we assessed participants' perceived VE usability and usefulness, self-efficacy, diabetes self-management behaviors, perceived social support, and diabetes knowledge using validated survey measures; and we recorded metabolic indicators (HbA1c, BP, BMI). Process data were continuously collected in the VE (log-ins, voice recordings, locations visited, objects interacted with, and movement). Data analysis included descriptive statistics, t tests to evaluate changes in mediators and outcomes over time, and depiction of utilization and movement data. Results: We enrolled 20 participants (13/20, 65\% white, 7/20, 35\% black), with an age range of 39-72 years (mean age, 54 years) and diabetes duration from 3 months to 25 years. At baseline, 95\% (18/19) and 79\% (15/19) of participants rated usefulness and ease of use as high on validated surveys with no significant changes at 3 or 6 months. Participants logged into the site a mean of 2.5 hours/week over the course of 6 months. High DSM class attendance was reflected by the largest percentage of time spent in the classroom (48.6\%). Self-efficacy, social support, and foot care showed significant improvement (P<.05). There were improvement trends in clinical outcomes that were clinically meaningful but did not reach statistical significance given the small sample size. Conclusions: Because relatively little is known about usability, acceptability, and efficacy of health interventions in VEs, this study constitutes an important, innovative first step in exploring the potential of VEs for facilitating DSM. The preliminary data suggest that VEs provide a feasible and useful platform for patients and educators that affects self-management and related mediators. Flexible access to both synchronous and asynchronous diabetes education, skill building activities, and support from a home computer remove barriers to attending clinic-based meetings. This program has potential for improving DSM in an easily disseminated alternative model. ",
doi="10.2196/resprot.3045",
url="http://www.researchprotocols.org/2014/2/e23/",
url="http://www.ncbi.nlm.nih.gov/pubmed/24713420"
}


@Article{info:doi/10.2196/resprot.2971,
author="Falasinnu, Titilola
and Gustafson, Paul
and Gilbert, Mark
and Shoveller, Jean",
title="Risk Prediction in Sexual Health Contexts: Protocol",
journal="JMIR Res Protoc",
year="2013",
month="Dec",
day="03",
volume="2",
number="2",
pages="e57",
keywords="prediction models",
keywords="Internet-based testing",
keywords="sexually transmitted infections",
abstract="Background: In British Columbia (BC), we are developing Get Checked Online (GCO), an Internet-based testing program that provides Web-based access to sexually transmitted infections (STI) testing. Much is still unknown about how to implement risk assessment and recommend tests in Web-based settings. Prediction tools have been shown to successfully increase efficiency and cost-effectiveness of STI case finding in the following settings. Objective: This project was designed with three main objectives: (1) to derive a risk prediction rule for screening chlamydia and gonorrhea among clients attending two public sexual health clinics between 2000 and 2006 in Vancouver, BC, (2) to assess the temporal generalizability of the prediction rule among more recent visits in the Vancouver clinics (2007-2012), and (3) to assess the geographical generalizability of the rule in seven additional clinics in BC. Methods: This study is a population-based, cross-sectional analysis of electronic records of visits collected at nine publicly funded STI clinics in BC between 2000 and 2012. We will derive a risk score from the multivariate logistic regression of clinic visit data between 2000 and 2006 at two clinics in Vancouver using newly diagnosed chlamydia and gonorrhea infections as the outcome. The area under the receiver operating characteristic curve (AUC) and the Hosmer-Lemeshow statistic will examine the model's discrimination and calibration, respectively. We will also examine the sensitivity and proportion of patients that would need to be screened at different cutoffs of the risk score. Temporal and geographical validation will be assessed using patient visit data from more recent visits (2007-2012) at the Vancouver clinics and at clinics in the rest of BC, respectively. Statistical analyses will be performed using SAS, version 9.3. Results: This is an ongoing research project with initial results expected in 2014. Conclusions: The results from this research will have important implications for scaling up of Internet-based testing in BC. If a prediction rule with good calibration, discrimination, and high sensitivity to detect infection is found during this project, the prediction rule could be programmed into GCO so that the program offers individualized testing recommendations to clients. Further, the prediction rule could be adapted into educational materials to inform other Web-based content by creating awareness about STI risk factors, which may stimulate health care seeking behavior among individuals accessing the website. ",
doi="10.2196/resprot.2971",
url="http://www.researchprotocols.org/2013/2/e57/",
url="http://www.ncbi.nlm.nih.gov/pubmed/24300284"
}


@Article{info:doi/10.2196/resprot.2727,
author="Kushnir, Vladyslav
and Cunningham, A. John
and Hodgins, C. David",
title="A Prospective Natural History Study of Quitting or Reducing Gambling With or Without Treatment: Protocol",
journal="JMIR Res Protoc",
year="2013",
month="Dec",
day="02",
volume="2",
number="2",
pages="e51",
keywords="gambling",
keywords="treatment",
keywords="life events",
keywords="motivational factors",
keywords="natural recovery",
keywords="prospective natural history study",
keywords="longitudinal study",
abstract="Background: Only a small percentage of gamblers ever seek treatment, often due to stigma, embarrassment, or a desire to handle their problems on their own. While the majority of pathological gamblers who achieve remittance do so without accessing formal treatment, factors related to successful resolution have not been thoroughly explored. Objective: Employing a prospective natural history design, the study will therefore undertake an investigation to explore life events, motivating factors, and strategies used by problem gamblers to quit or reduce their gambling without formal treatment. Methods: Prospective participants (19 years or older) currently gambling at problematic levels with strong intentions toward quitting gambling will be directed to fill out a Web-based survey. Eligible participants will subsequently complete a survey that will assess: (1) types, frequency, and amount of money spent on gambling, (2) life events experienced in the past 12 months, (3) level of autonomous motivation for change, and (4) use of treatment services. Every 3 months for the duration of one year following the completion of their baseline survey, participants will be sent an email notification requesting them to complete a follow-up survey similar in content to the baseline survey. The four surveys will assess whether participants have experienced changes in their gambling behaviors along with positive or negative life events and motivations for change since the last survey. Individuals who are in the action and maintenance stages of quitting gambling at follow-up will be also asked about their techniques and strategies used to quit or reduce gambling. At 18 months post baseline, participants will be asked to complete a fifth and final follow-up survey that will also assess whether participants have experienced any barriers to change and whether they resolved their gambling to low risk levels. Results: The study has commenced in May 2013 and is currently in the recruitment stage. The study is scheduled to conclude in 2016. Conclusions: As this study will examine the active ingredients in natural recovery from gambling problems, the results will inform ways of promoting change among the large number of problem gamblers who do not seek treatment as well as improve treatment for those who do seek help. The information gained will also be useful in identifying effective self-help strategies for those who face challenges in accessing treatment, may be incorporated in standard treatment, provide brief intervention techniques, as well as inform relapse prevention strategies. ",
doi="10.2196/resprot.2727",
url="http://www.researchprotocols.org/2013/2/e51/",
url="http://www.ncbi.nlm.nih.gov/pubmed/24297873"
}


@Article{info:doi/10.2196/resprot.2786,
author="Sadasivam, S. Rajani
and Volz, M. Erik
and Kinney, L. Rebecca
and Rao, R. Sowmya
and Houston, K. Thomas",
title="Share2Quit: Web-Based Peer-Driven Referrals for Smoking Cessation",
journal="JMIR Res Protoc",
year="2013",
month="Sep",
day="24",
volume="2",
number="2",
pages="e37",
keywords="Web-assisted tobacco interventions",
keywords="recruitment",
keywords="peer-driven chain referrals",
keywords="respondent-driven sampling",
abstract="Background: Smoking is the number one preventable cause of death in the United States. Effective Web-assisted tobacco interventions are often underutilized and require new and innovative engagement approaches. Web-based peer-driven chain referrals successfully used outside health care have the potential for increasing the reach of Internet interventions. Objective: The objective of our study was to describe the protocol for the development and testing of proactive Web-based chain-referral tools for increasing the access to Decide2Quit.org, a Web-assisted tobacco intervention system. Methods: We will build and refine proactive chain-referral tools, including email and Facebook referrals. In addition, we will implement respondent-driven sampling (RDS), a controlled chain-referral sampling technique designed to remove inherent biases in chain referrals and obtain a representative sample. We will begin our chain referrals with an initial recruitment of former and current smokers as seeds (initial participants) who will be trained to refer current smokers from their social network using the developed tools. In turn, these newly referred smokers will also be provided the tools to refer other smokers from their social networks. We will model predictors of referral success using sample weights from the RDS to estimate the success of the system in the targeted population. Results: This protocol describes the evaluation of proactive Web-based chain-referral tools, which can be used in tobacco interventions to increase the access to hard-to-reach populations, for promoting smoking cessation. Conclusions: Share2Quit represents an innovative advancement by capitalizing on naturally occurring technology trends to recruit smokers to Web-assisted tobacco interventions. ",
doi="10.2196/resprot.2786",
url="http://www.researchprotocols.org/2013/2/e37/",
url="http://www.ncbi.nlm.nih.gov/pubmed/24067329"
}