JMIR Research Protocols最新文献

{"title":"Authors' Reply: Posttrial Withdrawal Ethics in the Healthy Ageing Ecosystem for People With Dementia (HAAL) Study.","authors":"Giulio Amabili, Elvira Maranesi, Federico Barbarossa, Arianna Margaritini, Anna Rita Bonfigli, Fong-Chin Su, Chien-Ju Lin, Hsiao-Feng Chieh, Dianne Vasseur, Henk Herman Nap, Yeh-Liang Hsu, Dorothy Bai, Roberta Bevilacqua","doi":"10.2196/95516","DOIUrl":"https://doi.org/10.2196/95516","url":null,"abstract":"","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95516"},"PeriodicalIF":1.5,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of an Education Training Package to Anganwadi Workers for Improving Oral Health Knowledge Among Mother-Child Dyads in Kerala, India: Protocol for a Mixed Methods Implementation Study.","authors":"Venkitachalam Ramanarayanan, Chandrashekar Janakiram, Vineetha Karuveettil, Sreelakshmi Mohandas, Das P Anaswara","doi":"10.2196/91171","DOIUrl":"https://doi.org/10.2196/91171","url":null,"abstract":"<p><strong>Background: </strong>Maternal and child oral health remains a significant public health concern in India, contributing to early childhood caries, adverse pregnancy outcomes, and long-term health complications. Anganwadi workers (AWWs), under the Integrated Child Development Services Scheme (ICDS), are well positioned to promote preventive oral health behaviors. However, oral health education is not part of their core training. This protocol outlines an implementation research study to develop, deliver, and evaluate a contextualized oral health education training package through AWWs for mother-child dyads in Kochi, Kerala.</p><p><strong>Objective: </strong>The objectives of this study are to (1) assess the current oral hygiene knowledge, attitude, and behavior and identify barriers and facilitators for implementing the oral health education training package among AWWs, parents, and other key stakeholders; (2) evaluate the oral health education training package for coverage, acceptability, adoption, fidelity, and scalability; and (3) assess the impact of an oral health education training package on the improvement in oral health knowledge, attitude, and behavior among mothers.</p><p><strong>Methods: </strong>A mixed methods implementation study will be conducted across 100 Anganwadi centers in 3 phases following the Exploration, Preparation, Implementation, and Sustainment framework. Phase 1 will assess baseline oral hygiene practices and identify contextual barriers and facilitators using structured questionnaires and qualitative interviews. In phase 2, AWWs will be trained using a structured oral health education package and will deliver oral health messages to mother-child dyads during routine sessions. Implementation outcomes-acceptability, coverage, adoption, fidelity, and scalability-will be evaluated using observation checklists and program tracking tools. Phase 3 will assess the impact by evaluating changes in maternal oral health knowledge, attitude, and behavior through preintervention and postintervention questionnaires administered to a subsample of mothers. Dissemination of findings and planning for long-term integration into ICDS will also be undertaken.</p><p><strong>Results: </strong>The study obtained funding in May 2024. The data collection commenced in April 2025. A total of 101 Anganwadi centers have been enrolled. Permissions, stakeholder meetings, baseline data collection, preparation of the teaching module, and training of AWWs (September 2025) have been completed. Follow-up visits to assess implementation parameters are ongoing. Data collection is expected to be completed in April 2026, followed by data analysis in May 2026 and dissemination by July 2026.</p><p><strong>Conclusions: </strong>This study is expected to generate practical insights into the feasibility of integrating oral health education into ICDS through AWWs. The intervention will be embedded within existing ICDS touchpoints and supported by centra","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e91171"},"PeriodicalIF":1.5,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Posttrial Withdrawal Ethics in the Healthy Ageing Ecosystem for People With Dementia (HAAL) Study.","authors":"Praisewin Johny, Anish Kr","doi":"10.2196/93636","DOIUrl":"https://doi.org/10.2196/93636","url":null,"abstract":"","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e93636"},"PeriodicalIF":1.5,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Patient-Entered Electronic Health Data as a Strategy to Improve Quality of Care in a Diabetes Clinic: Protocol for a Randomized Controlled Trial.","authors":"Julia Hunter-Schouela, Lindsey Ure, Caroline Zuijdwijk, Elias Abou-Assaly, Alexandra Ahmet, Jennifer de Boer, Karine Khatchadourian, Stephen A Kutcher, Sarah E Lawrence, Deepti Reddy, Richard Webster, Ellen B Goldbloom","doi":"10.2196/89519","DOIUrl":"https://doi.org/10.2196/89519","url":null,"abstract":"<p><strong>Background: </strong>Quality care for pediatric type 1 diabetes (T1D) requires frequent, multidisciplinary visits. Technological and clinical innovation have led to changes in T1D management, resulting in increasing data exchange required during these visits. Capturing comprehensive personal health and diabetes-related information discretely and integrating it into the clinical workflow is critical for optimal T1D care but is time-consuming. Time spent on data transfer often results in less time for holistic care and can lead to unmet needs for patients, families, and health care providers, as well as increased time pressures in clinic. To address this, the Children's Hospital of Eastern Ontario developed a caregiver proxy-reported questionnaire distributed via the MyChart patient portal, allowing families to input care information ahead of visits with the aim of dedicating more clinic time to personalized care. The launch of this tool, which integrates caregiver-entered information into the physician's documentation workflow, brings the opportunity to systematically evaluate its impact on care quality and efficiency, with potential implications for broader adoption.</p><p><strong>Objective: </strong>Our objective is to evaluate the impact of a caregiver proxy-reported, electronic health record-integrated preclinic questionnaire (MyChart questionnaire) on the quality of care in a pediatric diabetes clinic, through measurement of its impact on caregiver-perceived quality of care compared to the standard of care using 2 validated measures of care quality. We also aim to explore the impact of the intervention on glycemic control and visit efficiency.</p><p><strong>Methods: </strong>We conducted a single-center, parallel-group randomized controlled trial designed for 222 children with T1D. Participants were randomly allocated in a 1:1 ratio to either the intervention (MyChart questionnaire) or standard care. Our primary outcome is caregiver-perceived quality of care, as measured by the Patient's Evaluation of the Quality of Diabetes Care at 8 months, administered with caregivers serving as proxy respondents for patients. Secondary outcomes are the Patient's Evaluation of the Quality of Diabetes Care at 4 months and Perceived Quality of Medical Care at 4 and 8 months. Tertiary outcomes include glycemic control and physician-reported visit efficiency at 4 and 8 months. Analysis of covariance models will be used to assess changes between baseline and postintervention outcomes across treatment groups.</p><p><strong>Results: </strong>Recruitment for this study began in April 2023 and was completed in February 2024, with a total of 139 participants enrolled. Data collection has concluded, and the first results are expected in the spring of 2026.</p><p><strong>Conclusions: </strong>This study is the first randomized trial to assess the impact of a caregiver proxy-reported, electronic health record-integrated, preclinic questionnaire distributed v","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e89519"},"PeriodicalIF":1.5,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Studying Contextual and Psychological Predictors of Physical Activity Among Emerging Adults: Protocol for an Ecological Momentary Assessment Study.","authors":"Sheereen M Harris, Ryan Chen, Calli Naish, Matthew Bourke, Steven R Bray, Matthew Y W Kwan","doi":"10.2196/87510","DOIUrl":"10.2196/87510","url":null,"abstract":"<p><strong>Background: </strong>Many adults are insufficiently active, posing a threat to public health. Research shows steep declines in physical activity during the emerging adulthood period. Psychological and socioenvironmental factors have been shown to be independently associated with engaging in physical activity. However, few studies have examined the cross-domain interactions between psychological and socioenvironmental factors on physical activity in real time. Real-time data collection methods can be leveraged alongside traditional nomothetic methods to gain a more comprehensive understanding of how physical activity is affected by dynamic changes to one's unique psychological and contextual state within a day.</p><p><strong>Objective: </strong>This paper describes the protocol for a study aiming to examine independent and interactive associations between psychological and contextual factors and real-time physical activity in emerging adults. Ecological momentary assessment (EMA) and device-based monitoring of physical activity will be used.</p><p><strong>Methods: </strong>The SCOPE (Studying COntextual and Psychological predictors of physical activity among Emerging adults) study will use an intensive longitudinal study design. A total of 124 emerging adults will be recruited, completing 2 waves of data collection consisting of an online survey followed by 7 days of EMAs 6 months apart. EMA surveys will be administered using the Pathverse smartphone app, and physical activity will be assessed using a Fitbit Versa 4 activity monitor.</p><p><strong>Results: </strong>The study was approved by the research ethics board at the University of Waterloo in November 2025. Recruitment and enrollment began in December 2025, and complete T1 data from 69 participants have been collected as of February 2026. It is expected that T1 data collection will be completed by April 2026, and T2 data collection will occur between June and October 2026. Data analysis on T1 data is expected to begin in May 2026. We anticipate results to be published in fall 2027.</p><p><strong>Conclusions: </strong>Exploring real-time associations between psychological and socioenvironmental factors and physical activity will provide a more comprehensive understanding of the dynamic barriers and facilitators influencing individuals' engagement in physical activity in their everyday lives. The outcomes of this work will help advance existing theories on behavioral choice and effort minimization and inform the development of decision rules for adaptive interventions that are tailored to individuals' unique and current context.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e87510"},"PeriodicalIF":1.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comprehensive Intervention to Promote Healthy Lifestyles and Prevent Cardiometabolic Diseases in Low-Income School Children From Mexico: Protocol for the ESCOLARISANO Randomized Controlled Trial.","authors":"Ana A Escárcega-Galaz, Elmer Enriquez-Rabago, Marcela Garcia-Moreno, Sara Leyva-Encinas, Cesar Robles-Aguilar, Mayra Arias-Gastelum, Gabriela Ulloa-Mercado, Pablo Gortares-Moroyoqui, Gabriela Maldonado-Ulloa, Juan F Hernandez-Chavez, Ana Renteria-Mexia","doi":"10.2196/82721","DOIUrl":"10.2196/82721","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Obesity is a serious public health issue affecting children in a progressively alarming manner; thus, nutrition education and behavior change interventions during childhood are a priority. Eating and physical activity behaviors are mainly influenced by the environment; therefore, lifestyle changes are often successful when interventions are implemented in places such as the home and school. Schools are fundamental for ensuring the development of students' personalities, skills, abilities, and long-term behaviors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to measure the effect of an intervention designed for low-income Mexican schoolchildren, focused on promoting healthy lifestyles for the prevention of obesity and cardiometabolic diseases.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study design is a randomized clinical trial (NCT05945862), with intervention groups paired with control groups of the same grade. Four elementary schools were selected based on district socioeconomic status. The study will be carried out for 1 year in four phases: (1) initial measurements, including anthropometry, blood pressure, psychosocial diagnosis, family medical history, and behavior variables, such as nutrition knowledge, dietary intake, sleep time and quality, and physical activity; (2) intervention implementation based on social cognitive theory, the behavior change wheel with the capability, opportunity, and motivation influencing behavior theoretical framework, and the transtheoretical theory, covering topics related to nutrition and healthy eating, child health, personal and sleep hygiene, physical activity, psychosocial well-being, and motivation; (3) postintervention measurements, including initial and behavioral measurements and intervention indicators; and (4) 6-month postintervention evaluation using the same initial and behavioral measures as in phase 1. Baseline differences by age, sex, socioeconomic status, and location will be analyzed using chi-square tests (qualitative variables) and analysis of covariance (quantitative variables). Multiple linear regression will test potential baseline associations between dependent variables (anthropometrics and blood pressure) and independent variables (diet, exercise, sleep time, family interaction, psychosocial well-being, and perception of childhood obesity). For comparing changes between the intervention and control groups at postintervention and at 6-month postintervention in anthropometrics, blood pressure, and behavioral variables, we will use multilevel mixed-effects regression models, given the hierarchical structure of participants nested within schools and the repeated measurements over time. SPSS and STATA software will be used with a significance level of P&lt;.05.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;From October 2023 to August 2024, a total of 451 participants were recruited from 4 different elementary schools in Sonora, México. As of February 2026, the data collected ar","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82721"},"PeriodicalIF":1.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148596/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Co-Design of a Physical Activity Maintenance Intervention for People With Stroke: Protocol for a Mixed Methods Study.","authors":"Katy Pedlow, Suzanne McDonough, Natalie Duff, Karen McConnell, Claire McFeeters, Angela Carlin, Noelene Hughes, Zoe Campbell, Andrew Bell, Aoife Stephenson, Gary Adamson, Jemma Hawkins, Sarah Howes","doi":"10.2196/89913","DOIUrl":"10.2196/89913","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Stroke is a global health problem that often causes physical disability and mental health issues for the survivor. While physical activity (PA) improves outcomes post stroke, it can be challenging to maintain. Barriers to maintaining PA post stroke include the setting of PA, motivation, and impairments from the stroke. There is often a desire to maintain PA after stroke, but effective interventions are currently limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to coproduce an intervention to support long-term PA maintenance for adults living with the effects of stroke in Northern Ireland. The objectives of this study are to understand the perspectives of key stakeholders on the components, structure, and content of an intervention to support PA maintenance and to coproduce and refine a prototype intervention to meet their specific needs and preferences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A mixed methods study will be conducted, consisting of three stages informed by the Centre for Development, Evaluation, Complexity and Implementation in Public Health Improvement (DECIPHer) co-production framework. Stage 1 will include a scoping review on PA maintenance in survivors of stroke and stakeholder consultation via focus groups to gain understanding from their perspective of PA. Survivors of stroke and their carers, physiotherapists, and care coordinators from community and voluntary organizations will be recruited from ongoing Post Rehabilitation Exercise Program (PREP) classes. Additional health care professionals with experience in PA and stroke will also be recruited via relevant organizations. Individuals who complete stage 1 focus groups will be invited to take part in stage 2 co-design workshops to develop a PA maintenance program for participants post PREP. Stage 3 will involve expert review of the co-production program by members of the project advisory board via a questionnaire survey. Qualitative data will be analyzed using reflexive thematic analysis from data collected in stages 1 and 2. Data from the scoping review will help shape the questions for the focus groups, and data from the focus groups will help inform questions for the three workshops. All stages will involve the stakeholders to gain feedback and suggestions for the next wave.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Five focus groups were conducted with 38 participants: three in-person (stroke survivors and their caregivers) and two online (one for PREP staff and one for other health and exercise professionals) between September and November 2025. Results from the focus groups identified two themes: shifting realities of physical activity post stroke and motivation through community. Eighteen participants subsequently consented to participate in three co-design workshops, which resulted in an intervention prototype being developed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study aims to co-develop an intervention to support PA maintenance in adults","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e89913"},"PeriodicalIF":1.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating a Digital Chronic Condition Prevention Intervention (THRIVE) in Australian General Practice: Protocol for a Mixed Methods Feasibility Study (ePREVENT-360).","authors":"Gillian Singleton, Elizabeth Halcomb, Andrew Bonney, Hassan Hosseinzadeh","doi":"10.2196/83105","DOIUrl":"10.2196/83105","url":null,"abstract":"<p><strong>Background: </strong>Chronic conditions are responsible for a growing burden of morbidity, mortality, and cost globally. Despite widespread recognition of the need for preventive care, general practice remains underresourced and primarily focused on treatment. Digital health interventions (DHIs) present a scalable solution to support person-centered preventive care, but evidence regarding the feasibility and acceptability of multirisk consumer-facing interventions in general practice remains limited.</p><p><strong>Objective: </strong>This study (ePREVENT-360) aims to evaluate the feasibility, acceptability, sustainability, and preliminary impact on health activation of a consumer-facing DHI, THRIVE (Tailored Health Risk Insights for Vital Empowerment) in Australian general practices.</p><p><strong>Methods: </strong>A mixed methods, pre-post feasibility study will be conducted in 5 general practices across New South Wales, Queensland, and Victoria. Adult consumers aged 30 to 65 years will use the THRIVE digital platform to receive chronic condition risk assessments, health scores, and action plans. Quantitative data will include engagement metrics, surveys, and chronic condition risk scores. Qualitative semistructured interviews with consumers and clinicians will provide data about acceptability, engagement, and sustainability. Quantitative data will be analyzed using descriptive and multilevel regression methods, while qualitative data will be analyzed thematically.</p><p><strong>Results: </strong>The study has secured funding in 2024 through an Australian General Practice Research Foundation and Hospital Contribution Fund of Australia Research Foundation Health Services Research Grant. Consumer recruitment commenced in December 2025. Recruitment of the 5 participating general practices was completed in March 2026. As of April 2026, all clinician preintervention interviews have been completed, and consumer recruitment has commenced, with 25 consents obtained. Data collection is ongoing, with follow-up expected to be completed by December 2026. Outcomes will inform the iterative refinement of interventions and future trial designs to assess effectiveness.</p><p><strong>Conclusions: </strong>This study will address a key evidence gap in the digital prevention space by evaluating the feasibility, acceptability, and sustainability of a multicondition DHI embedded in general practices. The findings will support the development of a larger adaptive controlled trial and inform future implementation.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e83105"},"PeriodicalIF":1.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13148338/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Closing the Gap to Interventions for Tuberous Sclerosis Complex-Associated Neuropsychiatric Disorders (TAND): Protocol for a Longitudinal Study of TAND Severity, Predictors, and Caregiver Well-Being (TANDem-2).","authors":"Petrus J de Vries, Nola Chambers, Erin Campbell, Lucas Gutierrez-Lafrentz, Tosca-Marie Heunis, Liezl Schlebusch, Guillaume Beaure d'Augères, Stacey Bissell, Anna Byars, Jamie Capal, Laís Cardozo, Sebastian Cukier, Peter Davis, Naomi Beth Epstein, Carla Fladrowski, Jennifer Flinn, Tanjala Gipson, Sarah Louise Goy, John Christopher Kingswood, Darcy Krueger, Francesca Little, Sugnet Lubbe, Rebecca Mitchell, Micaela Rozenberg, Mustafa Sahin, Mitchell Silva, Catherine Smith, Shoba Srivastava, Megumi Takei, Agnies van Eeghen, Mary Vasseghi, Jan-Paul Wagenaar, Robert Waltereit, Liesbeth De Waele, Anna C Jansen","doi":"10.2196/91726","DOIUrl":"https://doi.org/10.2196/91726","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Tuberous sclerosis complex (TSC) is a rare genetic disorder caused by pathogenic variants in the TSC1 or TSC2 genes. Apart from multisystem physical manifestations, most individuals with TSC experience TSC-associated neuropsychiatric disorders (TAND). Little is known about how TAND severity changes over time and what factors may predict these changes. Preliminary data suggest the presence of differential TAND severity trajectories. Caregiver well-being may act as a mediator of TAND severity, and a well-being intervention designed for caregivers of children with developmental disabilities may improve caregiver well-being.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The study aims are to (1) examine longitudinal trajectories of TAND severity in a large sample of individuals with TSC and to examine potential predictors of differential trajectories, (2) evaluate the association between caregiver well-being characteristics, TAND severity, and severity trajectories, and (3) adapt and evaluate the feasibility, acceptability, and potential efficacy of a brief, online group-based well-being intervention for family caregivers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;For the first 2 aims, 500 individuals with TSC or their caregivers will be recruited in an accelerated longitudinal design to document TAND severity at 5 time points over 12 months via a web-based app. At each time point, participants will complete demographic, TSC characteristics, intervention, and well-being questionnaires. Data will be analyzed using latent class mixed and multinomial regression modeling (aim 1) and structural equation and mediation modeling (aim 2). Participatory methods will be used to adapt an existing caregiver well-being intervention for the TSC community (aim 3). Thirty caregivers will be invited to participate in the adapted group-based online well-being intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded from July 2024 (HT94252410790 and HT94252410791), and ethics approvals were obtained from the University of Cape Town (July 2024), Vrije Universiteit Brussel (November 2024), and the Department of Defense Office of Human Research Oversight (December 2024). The TAND Toolkit app was adapted for longitudinal data collection (aims 1 and 2). Recruitment started in December 2025 and will continue until 500 participants are enrolled (anticipated December 2026). Primary outputs are expected by July 2028. For aim 3, experiential and adaptation workshops were completed in June 2025, the pilot intervention was delivered in November 2025, and data collection will continue till May 2026. Outputs are expected by December 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Identification of differential longitudinal TAND trajectories and their correlates will stimulate research in TSC and generate evidence for the self-report quantified TAND checklist as a clinical outcome measure. Understanding the association between caregiver well-being and TAND severity will","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e91726"},"PeriodicalIF":1.5,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Empathy in AI for Health and Care Settings-Definition, Expression, and Measurement: Protocol for a Scoping Review.","authors":"Alastair Howcroft, Steve Benford, Michel Valstar, Holly Blake","doi":"10.2196/93078","DOIUrl":"https://doi.org/10.2196/93078","url":null,"abstract":"<p><strong>Background: </strong>\"Empathy\" is widely discussed in health and care settings and is increasingly claimed as an attribute of artificial intelligence (AI) systems (eg, socially assistive robots and chatbots), but the term is used inconsistently across the literature. In research on AI in these settings, it is often unclear what authors mean by \"empathic AI,\" what systems do that is intended to be empathic, and how empathy is assessed. This matters because perceived empathy can shape users' experience of AI-mediated support and their willingness to engage with these systems.</p><p><strong>Objective: </strong>This study aims to map how empathy is defined, operationalized, and evaluated in peer-reviewed AI research in health and care settings and to describe interactional design features commonly reported in systems perceived as more empathic.</p><p><strong>Methods: </strong>This protocol outlines a scoping review following Joanna Briggs Institute guidance and is reported in accordance with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). We use \"AI\" as an umbrella term and will extract and classify each system's type (eg, rule-based or large language model-based). We will search PubMed (MEDLINE), Embase, PsycInfo, CINAHL, Scopus, IEEE Xplore, and the ACM Digital Library databases. Two reviewers will screen titles and abstracts using ASReview and full texts by using Rayyan. We will extract study characteristics, empathy definitions and framing, empathy-related system behaviors and design features, and evaluation methods, and synthesize findings thematically.</p><p><strong>Results: </strong>This scoping review forms a part of the first author's doctoral research, funded by an Engineering and Physical Sciences Research Council studentship from October 2025. Pilot searches were conducted on January 20, 2026; full searches and synthesis are planned for 2026, with publication anticipated in 2027. The review will produce (1) a summary of how empathy is defined in AI research in health and care settings, (2) a grouped list of the main empathic interactional behaviors and design features described, and (3) an overview of how empathy is measured across studies. Where studies report empathy ratings, we will summarize which features are most commonly present in higher-rated systems within comparable contexts.</p><p><strong>Conclusions: </strong>The review will provide a clearer picture of what researchers mean by \"AI empathy\" in health and care settings and what system features are most commonly used when trying to build it. These findings may help guide the development of more empathic AI systems.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/93078.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e93078"},"PeriodicalIF":1.5,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147838092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}