JMIR Research Protocols最新文献

{"title":"Chitosan Nanoparticles Combined With Titanium-Prepared Platelet-Rich Fibrin for Socket Preservation in Postextraction Sites: Protocol for a Single-Arm Clinical, Radiographic, and Histomorphometric Study.","authors":"Rutuja Karamore, Prasad Dhadse, Sanehi Punse","doi":"10.2196/79532","DOIUrl":"10.2196/79532","url":null,"abstract":"<p><strong>Background: </strong>Alveolar ridge resorption following tooth extraction can compromise subsequent implant placement. Socket preservation techniques aim to minimize dimensional changes and promote favorable bone healing. Chitosan nanoparticles combined with titanium-prepared platelet-rich fibrin represent a biologically active approach to ridge preservation.</p><p><strong>Objective: </strong>This study aims to evaluate longitudinal changes in alveolar ridge dimensions and bone quality following socket preservation using chitosan nanoparticles combined with titanium-prepared platelet-rich fibrin.</p><p><strong>Methods: </strong>This is a single-arm prospective clinical study involving systemically healthy participants requiring tooth extraction. Clinical, radiographic, and histomorphometric assessments will be performed at baseline and at follow-up visits at 3 and 6 months. Statistical analysis will be conducted using within-subject repeated-measures approaches.</p><p><strong>Results: </strong>No external funding was received for this research. The manuscript was submitted before recruitment of participants had started and no clinical data had been collected or analyzed. Clinical, radiographic, and histomorphometric outcomes will be evaluated to assess changes in the dimensions of the alveolar ridge, bone density, and quality of regenerated bone during the postextraction healing period. Clinical and radiographic evaluation will be performed at baseline, 3 months, and 6 months. Histomorphometric analysis will be performed on bone core biopsy samples taken at the time of implant placement. The results of the study will be reported after data collection and analysis.</p><p><strong>Conclusions: </strong>This protocol outlines a standardized approach to evaluating the clinical, radiographic, and histomorphometric outcomes of socket preservation using chitosan nanoparticles combined with titanium-prepared platelet-rich fibrin. The findings from this study may inform the design of future controlled clinical trials.</p><p><strong>Trial registration: </strong>Clinical Trials Registry of India CTRI/2025/06/089715; https://tinyurl.com/4u6698xs.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/79532.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e79532"},"PeriodicalIF":1.6,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13684121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110084","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":"RESONANCE: Protocol for a Nationwide Cohort Study of Chronic Liver Diseases Using the French National Health Data System.","authors":"Aurore Baron, Laure Tron, Frédéric Balusson, Vaele Zannou, Victoria Mignot, Anne Ego, Anna Borowick, Thomas Decaens, Emmanuel Oger, Sébastien Bailly, Charlotte Costentin","doi":"10.2196/89577","DOIUrl":"10.2196/89577","url":null,"abstract":"<p><strong>Background: </strong>Chronic liver diseases (CLDs) are frequent in Europe, including in France, and are mainly driven by alcohol, metabolic dysfunction (diabetes and obesity), and viral hepatitis. Although risk factors are well established and easy to identify, CLDs are frequently diagnosed at an advanced stage, translating into poor prognosis. Descriptive data on CLD burden in France remain scarce, and health trajectories of these patients are uncharted. However, such data are crucial to guide clinical practice, to determine the target population for personalized public health policies, and to develop innovative strategies to reduce inequities in access to health care and ultimately improve survival.</p><p><strong>Objective: </strong>The aim of the French RESONANCE cohort is to provide a detailed description of CLD burden in France and study health trajectories.</p><p><strong>Methods: </strong>The RESONANCE cohort was derived from the French National Health Data System (Système National des Données de Santé [SNDS]). Patients with at least one CLD-specific ICD-10 (International Statistical Classification of Diseases, Tenth Revision) code (including primary liver cancer [PLC] and rare diseases), or related procedure, biology, or drug and/or a cause of death related to one of these ICD-10 codes, were targeted from the 2% representative SNDS sample (ESND [Échantillon du Système National des Données], Simplified Sample of the French National Health Data System). Demographic characteristics, risk factors, comorbidities, etiologies, social environment and health care accessibility, as well as severity of the liver disease at first identification and medical management, were assessed. This paper describes the procedures used to build the cohort, outlines main variables, and defines the research objectives.</p><p><strong>Results: </strong>Overall, 26,663 incident and prevalent CLD cases identified between 2015 and 2021 were included in the RESONANCE cohort. Men accounted for 58.1% (15,490) of the cohort, and the mean age was 59.9 (SD 17.4) years. The cohort covers a broad spectrum of etiologies, including alcohol-related liver disease (7580/26,663, 28.4%), metabolic-associated liver disease (6030/26,663, 24.8%), viral hepatitis (3450/26,663, 12.9%), and rare liver diseases (839/26,663, 3.1%). A total of 43% (11,461/26,663) of the patients lived in a socially deprived environment (according to the 4th and 5th quintiles of the French Deprivation Index).</p><p><strong>Conclusions: </strong>This paper will enable a detailed, real-world analysis of epidemiology, care trajectories, and outcomes of CLDs across France. With a particular focus on gender and socioeconomic disparities, it offers a unique opportunity to identify vulnerable populations and inform proportionate universalism strategies in prevention and care.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/89577.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e89577"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13680907/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109588","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":"Implementing Sustainable Mobile Health Technology to Optimize a Smoking Cessation Program for Lao People With HIV (Project I-STOP): Protocol for a Hybrid Type-2 Pragmatic Effectiveness-Implementation Study.","authors":"Phonepadith Xangsayarath, Cate Moriasi, Phayvanh Keopaseuth, Khatthanaphone Phandouangsy, Khanti Thongkham, Bouathong Simanovong, Michael S Businelle, Steven K Sutton, Margaret M Byrne, Kea L Turner, Jennifer I Vidrine, Khue-Tu T Doan, Chanthavy Soulaphy, Kanchana Thilakoun, Sarah R Jones, Thanh Cong Bui, Damon J Vidrine","doi":"10.2196/100518","DOIUrl":"https://doi.org/10.2196/100518","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Tobacco use remains the leading modifiable risk factor for causing cancer worldwide, particularly among people with HIV. In Laos, 61%-80% of male people with HIV and 3%-10% of female people with HIV smoke cigarettes. They currently have no theoretically and empirically based smoking cessation support. Our team developed a scalable and affordable mHealth (mobile health)-based automated treatment program to support Lao and Cambodian smokers to quit smoking. We also pioneered the Ask-Advise-Connect approach to identify patients who smoke and to connect them to treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This hybrid type-2 pragmatic effectiveness-implementation study aims to compare 2 smoking cessation implementation strategies in 8 antiretroviral therapy (ART) clinics in the 6 most populous regions across Laos, using a parallel cluster randomized trial design.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will compare an Ask-Advice-Connect approach paired with an mHealth-based automated treatment program (AA-MAP) with an Ask-Advice-Connect approach paired with less resource-intensive printed self-help material (AA-SH). To guide assessment of implementation determinants and outcomes, we use the Practical, Robust Implementation and Sustainability Model framework. Aim 1 is to evaluate the reach and effectiveness of AA-MAP vs AA-SH. Reach is the proportion of people with HIV who smoke and are willing to make a quit attempt that enroll in treatment. Effectiveness is the proportion of enrolled participants (n=up to 1200) who achieve biochemically confirmed point prevalence abstinence 6 months after enrollment. We hypothesize that compared with AA-SH, AA-MAP will have a lower reach but will be more effective. We will also estimate the real-world impact (impact = reach × effectiveness) of each intervention. Aim 2 is to evaluate other implementation outcomes (eg, adoption, implementation fidelity, and sustainability) and identify implementation determinants of AA-MAP and AA-SH in the ART clinic setting using mixed methods. Aim 3 is to conduct a comprehensive assessment of the resource use and costs of implementing AA-MAP and AA-SH and calculate the absolute and relative cost-effectiveness of the 2 intervention strategies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study has been funded since August 2024. This study was approved by the ethical review boards of the Lao Ministry of Health-National Ethics Committee for Health Research and the University of Oklahoma Health Campus. The Multiple Principal Investigators met with the selected ART clinics. As of September 2026, we have launched the implementation of AA-SH and AA-MAP at 4 ART clinics. We plan to expand the implementation at the other ART clinics by December 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This project will contribute important actionable inputs that will inform the influential Lao National Tobacco Control Committee and Ministry of Health to implement the strategies in diverse h","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e100518"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13638074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110108","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":"CYMEDSEC Cybersecurity Performance in Remote Patient Monitoring Systems in a Live Hospital Setting: Protocol for an Observational Study.","authors":"Michela Falcone, Francesco Giuliani, Stephen Gilbert, Oscar Freyer, Francesco Ricciardi","doi":"10.2196/98934","DOIUrl":"10.2196/98934","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Remote patient monitoring (RPM) systems based on the Internet of Medical Things (IoMT) technologies are increasingly integrated into chronic disease management and telemedicine pathways. Despite their widespread adoption, cybersecurity performance, system resilience, and user behavior in real-world clinical environments remain underexplored. Existing evidence is fragmented, often limited to laboratory simulations or vendor-driven assessments, leaving a critical gap in understanding how cybersecurity risks across the full life cycle of RPM systems deployed in health care settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to systematically analyze the cybersecurity posture, system resilience, and user behavior across the full life cycle of IoMT-enabled RPM systems in a real-world hospital and home-care environment. The study aims to generate empirical evidence on how technical safeguards, operational workflows, and human factors influence cybersecurity risks during procurement, integration, deployment, routine use, and decommissioning of these platforms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This observational study will analyze 2 independent RPM systems used for chronic disease monitoring in a real-world hospital setting. The assessment framework includes (1) system-log analytics to evaluate authentication events, device connectivity, update and patch management, and anomalous behaviors; (2) a controlled phishing simulation targeting health care professionals to assess susceptibility and response patterns; (3) an evaluation of update management processes and vendor-hospital interactions; (4) measurement of cybersecurity awareness and practices among patients and health care professionals using validated instruments; and (5) mapping of vulnerabilities across all life cycle phases, from procurement to decommissioning. Although the study includes cybersecurity training, preassessments/postassessments, and controlled phishing and update-management scenarios, these activities are part of the observational framework and are not designed as experimental interventions that have an impact on the clinical aspects of patient care. Quantitative data will be analyzed using descriptive and inferential statistics, while qualitative insights from operational workflows will be integrated to contextualize system performance. Ethical approval has been obtained from the institutional ethics committee.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The CYMEDSEC (enhanced cybersecurity for networked medical devices through optimization of guidelines, standards, risk management, and security by design) project received funding from the European Union's Horizon Europe program (grant 101094218) and started on November 1, 2024. Ethical approval was obtained on December 18, 2025, and institutional authorization on January 29, 2026. Patient enrollment is scheduled to begin on April 1, 2026. At the time of paper submission, no patients were recruited. Data","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e98934"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13638068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110052","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":"Evaluation of Ambient Voice Technology in the National Health Service in England: Protocol for a Phase 2 Study.","authors":"Stephen Morris, Jenny Shand, Theo Georghiou, Kevin Herbert, Rachel Lawrence, Raj Mehta, Pei Li Ng, Lucina Rolewicz, Holly Elphinstone, Holly Walton","doi":"10.2196/105261","DOIUrl":"https://doi.org/10.2196/105261","url":null,"abstract":"<p><strong>Background: </strong>Ambient voice technology (AVT) uses conversational AI to record and organize clinical consultations in real time. It is being adopted quickly across the National Health Service (NHS). However, evidence about its effects on productivity, costs, or staff experience across different health care settings is limited. Phase 1 of this research program developed a taxonomy, logic model, and outcome framework for evaluating AVT. Phase 2 will carry out a multisite, mixed methods evaluation of AVT in 4 NHS trusts. These include mental health outpatient services, acute hospital outpatient clinics, and accident and emergency departments.</p><p><strong>Objective: </strong>This study aims to explore the real-world impact of AVT on productivity, costs, and staff experience across NHS adult services.</p><p><strong>Methods: </strong>The study includes three parts: (1) a quantitative quasi-experimental analysis of routine NHS data to estimate the impact of AVT on documentation time, clinician activity, and service outcomes; (2) a comprehensive health economic evaluation comprising cost-consequence analysis, cost-benefit analysis, and budget impact modeling; and (3) interviews with up to 36 staff from 3 services (mental health outpatient, acute hospital outpatient, and accident and emergency) to explore their experience of using AVT, their views on its impact, and what helps and gets in the way of its use. Sites will be chosen to include different care settings, organizational environments, and AVT products. Quantitative and economic analyses will use NHS electronic health records and national datasets to understand changes over time and measure the impact of AVT. Interview data will be analyzed using thematic analysis and rapid assessment procedures to identify key themes. All study findings will be combined to give a clear view of AVT and its impact.</p><p><strong>Results: </strong>Data collection is expected to begin in August 2026 and conclude by January 2027. Publication of results is anticipated in February 2027.</p><p><strong>Conclusions: </strong>This evaluation will provide real-world evidence on the productivity, economic, and experiential impacts of AVT in the NHS. Outputs will include peer-reviewed papers, a slide-deck summary for the funder, and a publicly available health economic decision-support tool to help NHS organizations decide whether they should adopt AVT.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e105261"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13637992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110050","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":"GENDER-Q Youth Patient-Reported Outcome Measure: Protocol for an International Cross-Sectional Field Test Study.","authors":"Anne F Klassen, Charlene Rae, Shane D Morrison, Natasha Johnson, Karine Khatchadourian, Jack Graesser, Manraj N Kaur","doi":"10.2196/100420","DOIUrl":"https://doi.org/10.2196/100420","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The need for gender-affirming care (GAC) for young people has increased rapidly worldwide. GAC includes social, psychological, and medical interventions aimed at alleviating gender-related distress. Given that many outcomes of GAC relate to how young people function and feel, a rigorously developed patient-reported outcome measure (PROM) is needed. To address this need, GENDER-Q Youth was developed with extensive input from youth with lived experience. Concept elicitation interviews were performed with 47 youth from Canada and the United States. A conceptual framework and draft PROM were developed and refined with feedback from 33 experts and 17 youth, and were pilot tested with 406 older youth. The field test version of GENDER-Q Youth includes 16 independently functioning scales (248 items) that measure health-related quality of life, gender practices, voice, and experience of care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This paper outlines the protocol for an international cross-sectional study to field test GENDER-Q Youth in a sample of transgender and gender diverse (TGD) adolescents and young adults aged 12 to 25 years receiving GAC.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study follows international guidelines for PROM development and validation (eg, US Food and Drug Administration and Consensus-Based Standards for the Selection of Health Measurement Instruments [COSMIN]). GENDER-Q Youth was translated into Danish, Dutch, and German following the Professional Society for Health Economics and Outcomes Research (ISPOR) guidelines for the translation and cultural adaptation of PROMs. For the field test, TGD youth are being recruited using multiple strategies (eg, face-to-face, emails, and so on). A REDCap survey is used to collect sociodemographic and clinical data. Branching logic is used to ensure relevant GENDER-Q Youth scales are completed as some scales are gender-specific. For psychometric analysis, Rasch measurement theory (RMT) analysis will be used to examine fit of the observed data to the Rasch model. A series of tests and criteria will examine item fit and scale reliability and validity. Test-retest reliability will be examined with intraclass correlation coefficients. For construct validity, 147 predefined hypotheses of expected group differences and correlations between GENDER-Q Youth scales will be examined. Acceptance of at least 75% of hypotheses is considered sufficient evidence of construct validity per COSMIN criteria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The research described in this protocol is funded by a Canadian Institutes of Health Research Sex and Gender Science Chair (April 2020) and supported by a Canada Research Chair in Patient-Reported Outcomes (April 2025). With the Danish, Dutch, and German translations now completed, the international field test is underway in Canada, Europe, Australia, and the United States. Data collection and analysis are expected to be completed by the end of 2026.&lt;/p&gt;","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e100420"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13637991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110018","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":"Hearing Loss Prevention Training for Spanish-Speaking Farmworkers: Protocol for a Community-Engaged Hybrid Type 1 Pilot Study.","authors":"Laura Coco, Tracy L Finlayson, Nicolas López-Gálvez, Priscila Ruedas, Ana L Rosiles, Briana Toji Ruiz, Brianna Angel, Emma Torres, María Luisa Zúñiga","doi":"10.2196/93134","DOIUrl":"https://doi.org/10.2196/93134","url":null,"abstract":"<p><strong>Background: </strong>Noise-induced hearing loss is permanent yet preventable. Agricultural workers routinely experience hazardous noise exposure, and hearing protection use remains low. Existing interventions emphasize individual knowledge and intentions and have rarely been tested using objective outcome measures. This protocol describes the adaptation and pilot evaluation of an individual-level component of a multilevel noise-induced hearing loss prevention intervention for farmworkers. This pilot focuses on refining and testing a brief digitally delivered novella.</p><p><strong>Objective: </strong>The objectives of this study are to (1) culturally and linguistically adapt a digitally delivered, Spanish-language entertainment-education hearing protection training (digital novella with facilitated discussion and coached earplug fitting) for farmworkers in the Southwest United States, using community-based participatory research; and (2) pilot test the adapted intervention to assess acceptability, feasibility, and appropriateness and to estimate preliminary effect sizes for changes in objective hearing protector fit.</p><p><strong>Methods: </strong>This is a single-arm, pre-post, Hybrid Type 1 effectiveness-implementation pilot study. Phase 1 includes formative interviews with farmworkers and farm supervisors (n=30), informed by the Consolidated Framework for Implementation Research, to guide adaptation of training content and delivery. Phase 2 involves a single training session delivered to farmworkers not involved in the formative work (n=15). The primary exploratory outcome is pre-post change in the Personal Attenuation Rating, an objective measure of hearing protector fit. Secondary outcomes include changes in hearing protection beliefs and implementation outcomes (acceptability, feasibility, and appropriateness).</p><p><strong>Results: </strong>Funding for this study was obtained in July 2025, and the study was registered on ClinicalTrials.gov in December 2025 (NCT07271290). Phase 1 recruitment began in July 2025, and data collection concluded in January 2026, with 30 participants enrolled. Phase 2 pilot recruitment began in July 2026, and 1 participant had been enrolled as of July 2026. Phase 2 data collection is expected to conclude in Spring 2027. Data analysis will follow completion of data collection, and study findings are expected to be published in 2028.</p><p><strong>Conclusions: </strong>This protocol describes a community-engaged adaptation and pilot evaluation of a culturally tailored, digitally delivered hearing protection microtraining for farmworkers. By pairing objective fit testing with pragmatic implementation measures and systematic adaptation tracking, the study will assess feasibility and estimate preliminary effect sizes to inform a subsequent multilevel trial that integrates supervisor and organizational components.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e93134"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13638070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110060","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":"Reminder Strategies to Improve Meal-Logging Adherence: Protocol for a Microrandomized Trial.","authors":"Magdalena Fuchs, Victoria Brügger, Qiuhan Jin, Benjamin Wirth, Stefan Bilz, Florian von Wangenheim, Michael Brändle, Tobias Kowatsch, Mia Jovanova","doi":"10.2196/100239","DOIUrl":"https://doi.org/10.2196/100239","url":null,"abstract":"<p><strong>Background: </strong>Accurate measurement of lifestyle factors is central to understanding how daily behaviors act as risk factors or protective buffers to noncommunicable diseases. While wearable devices enable passive monitoring of physical activity or sleep, nutritional intake still depends on active participant input, such as manual dietary logs or image-based recordings. Adherence to such logging tasks often declines rapidly, impacting data completeness and clinical utility. Theory-based reminders drawing on loss-framing or logging consistency feedback (ie, tracking streaks) can improve adherence to lifestyle data collection, but the effects of these strategies on repeated dietary logging remain unclear.</p><p><strong>Objective: </strong>The study aims to examine the effects of 2 theory-driven reminder strategies-loss-framing and logging consistency-on adherence to repeated, image-based meal logging.</p><p><strong>Methods: </strong>We conducted a microrandomized trial embedded within a 4-week observational lifestyle phenotyping study in Switzerland (N=200, age ≥45 y, BMI ≥25 kg/m²). Participants photographed their meals at each mealtime (breakfast, lunch, and dinner) using a mobile app over 28 days. A decision point was scheduled prior to participant-defined habitual mealtimes. Participants were randomly assigned with equal probability to (1) a reminder emphasizing loss of a daily financial reward for not logging (\"loss-framing\"), (2) a reminder providing feedback on recent logging consistency (\"logging consistency\"), or (3) a neutral reminder (\"active control\"). The proximal outcome is whether the participant logs a meal within 2 hours of receiving a reminder. Participants earned a daily financial reward contingent on meal-logging completion. To estimate intervention effects, we will use marginal excursion effect models for binary outcomes, adjusting time-varying covariates (eg, day in study) and baseline covariates (eg, age and gender). Ethics approval for this study was granted by the Cantonal Ethics Committee of Eastern Switzerland (BASEC ID 2025-00972).</p><p><strong>Results: </strong>Enrollment began in November 2025, and the study was initiated on December 8, 2025. As of August 2026, 130 participants have been recruited, 120 have been enrolled, and 76 participants have completed the study, with an anticipated completion date of January 2027. Data analysis has not yet begun, and study results are expected to be published in Q2 2027.</p><p><strong>Conclusions: </strong>By clarifying the proximal effects of loss-framed and consistency-based reminders, findings will inform the design of future digital health studies to improve meal-logging adherence in daily life. This work contributes to the development of scalable, theory-driven reminder strategies for enhancing dietary data quality in observational and interventional research.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e100239"},"PeriodicalIF":1.6,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13637989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109500","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":"Technology-Assisted Cognitive Support for Older Adults With Mild Cognitive Impairment: Study Protocol for the DHEAL-COM COGNITIVE Quasi-Experimental Pilot Study.","authors":"Roberta Bevilacqua, Elvira Maranesi, Elisa Felici, Rachele Alessandra Marziali, Arianna Margaritini, Arianna Sgolastra, Lucia Paciaroni, Alessandra Raccichini, Giuseppe Pelliccioni, Lucrezia Grassi, Carmine Tommaso Recchiuto, Fabrizia Lattanzio, Antonio Sgorbissa, Giulio Amabili","doi":"10.2196/80233","DOIUrl":"https://doi.org/10.2196/80233","url":null,"abstract":"<p><strong>Background: </strong>Mild cognitive impairment (MCI) represents a transitional phase between normal aging and dementia. While no pharmacological treatments have proven effective, nonpharmacological interventions, such as cognitive stimulation and psychosocial support, have shown promise. Integrating digital tools and socially assistive robotics may improve engagement, personalization, and access to care, contributing to the preservation of cognitive function and overall well-being in older adults.</p><p><strong>Objective: </strong>The DHEAL-COM COGNITIVE pilot study aims to evaluate the feasibility, acceptability, and preliminary efficacy of a sociotechnological intervention that combines digital cognitive stimulation, social robot interaction, and group training in digital and health literacy to counteract cognitive decline.</p><p><strong>Methods: </strong>This is a single-blind, quasi-experimental feasibility trial involving 60 older adults with MCI, recruited from the Neurology and Alzheimer Units of IRCCS INRCA (INRCA - IRCCS Istituto Nazionale di Ricovero e Cura per Anziani). Participants were allocated into 2 groups: the experimental group received home-based cognitive training via the Brainer app, a month-long interaction with the NAO social robot, and weekly group sessions on eHealth literacy and cognitive stimulation; the control group received a well-being booklet with optional activities. Assessments were conducted at baseline, postintervention after 12 weeks, and follow-up after 3 months, using validated instruments, such as the Montreal Cognitive Assessment, the EQ-5D-5L, the Italian version of the eHealth Literacy Scale, the System Usability Scale, the unified theory of acceptance and use of technology, and the Psychological Well-Being Scale. Descriptive statistics will be used to summarize feasibility, usability, and acceptability outcomes, while preliminary differences over time will be explored using appropriate inferential analyses, acknowledging that the study is not powered to detect effectiveness.</p><p><strong>Results: </strong>Patient recruitment began in March 2025 and continued through September 2025. As of April 2026, 36 patients have been recruited, with 18 participants per group. The trial started in May 2025 and ran throughout the year. Results will focus on changes in cognitive performance, psychological well-being, quality of life, eHealth literacy, and user acceptability and usability of the technologies. Findings will be analyzed quantitatively and qualitatively and are expected to be published by the end of 2026.</p><p><strong>Conclusions: </strong>The DHEAL-COM COGNITIVE study proposes an innovative, integrated intervention for older adults with MCI, using digital platforms and social robotics to support cognitive health and autonomy. This pilot study represents a promising step toward a more integrated and technology-supported model of care for older adults with MCI.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80233"},"PeriodicalIF":1.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13632969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109529","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":"Development and Validation of an Extraoral Condyle Locating Device and Its Effect on Low-Level Laser Therapy in Patients With Skeletal Class II Malocclusion: Protocol for a 2-Phase Randomized Controlled Trial.","authors":"Shilpa Kendre, Pallavi Daigavane","doi":"10.2196/94481","DOIUrl":"10.2196/94481","url":null,"abstract":"<p><strong>Background: </strong>Precise localization of the mandibular condyle is essential for extraoral therapeutic procedures such as low-level laser therapy (LLLT) in patients with skeletal class II malocclusion undergoing myofunctional appliance therapy. Conventional localization methods rely on palpation and visual estimation, which are operator dependent and may compromise reproducibility and treatment outcomes. To address this limitation, a spectacle-mounted extraoral condyle locating device (EOCLD) has been developed to facilitate accurate and consistent condylar targeting.</p><p><strong>Objective: </strong>This study aims to develop and validate the EOCLD for precise condylar localization and evaluate its impact on the clinical efficacy of LLLT in patients with skeletal class II malocclusion undergoing myofunctional appliance therapy.</p><p><strong>Methods: </strong>This 2-phase study will be conducted in patients aged 10 to 13 years in a growth phase with skeletal class II malocclusion. In phase 1, the EOCLD will be evaluated for accuracy and reproducibility using standardized lateral cephalometric imaging. In phase 2, a prospective randomized controlled trial will be conducted in which participants undergoing myofunctional appliance therapy will be randomly allocated to either EOCLD-guided LLLT or conventional unguided LLLT. Skeletal and dentoalveolar changes will be assessed using standardized cephalometric analyses, while condylar growth and mandibular changes will be evaluated using pretreatment and posttreatment cone beam computed tomography (CBCT) imaging. Treatment duration, patient-reported comfort, and compliance will also be assessed.</p><p><strong>Results: </strong>The study is self-funded and received approval from the institutional ethics committee on November 28, 2025. Phase 1 data collection took place from May 21 to August 30, 2026, with EOCLD validation performed in 50 participants. As of September 2026, the data are undergoing statistical analysis. Phase 2 is scheduled to commence on December 1, 2026.</p><p><strong>Conclusions: </strong>This study will establish the clinical validity of the EOCLD and determine whether guided LLLT enhances treatment efficiency and skeletal outcomes in skeletal class II therapy.</p><p><strong>Trial registration: </strong>Clinical Trials Registry-India CTRI/2026/02/102982; https://tinyurl.com/4t3bwrnz.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/94481.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e94481"},"PeriodicalIF":1.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13675681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110054","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}