JMIR Research Protocols最新文献

{"title":"Oral vs Intravenous Fluid Therapy in Emergency Department Patients: Protocol for a Randomized Controlled Feasibility and Noninferiority Trial.","authors":"Peter Biesenbach, Mette Rahbek Kristensen, Mikkel Brabrand, Christian Backer Mogensen, Line Emilie Laugesen","doi":"10.2196/95459","DOIUrl":"10.2196/95459","url":null,"abstract":"<p><strong>Background: </strong>Intravenous fluid therapy is widely used in emergency departments (EDs) to treat hypovolemia and hypotension. However, its hemodynamic effects are often modest and short-lived. Intravenous fluid therapy requires a peripheral venous catheter, which increases the risk of complications such as catheter failure and phlebitis. Oral fluid therapy represents a simple, noninvasive alternative that has been shown in physiological studies to expand plasma volume and increase blood pressure. No randomized trial has compared oral with intravenous fluid therapy in a general adult ED population. Evidence regarding the feasibility of randomized comparisons of fluid administration modes and whether oral fluid administration can reliably deliver the prescribed volume remains limited.</p><p><strong>Objective: </strong>This study aims to evaluate the feasibility of conducting a randomized controlled trial of oral vs intravenous fluid therapy in ED patients requiring fluid replacement and to determine whether oral fluid therapy is noninferior to intravenous fluid therapy in achieving the prescribed fluid volume.</p><p><strong>Methods: </strong>This investigator-initiated, multicenter, open-label randomized controlled feasibility and noninferiority trial will enroll 250 adult ED patients prescribed ≥1000 mL of intravenous crystalloid therapy. Participants will be randomized 1:1 to receive either oral fluids or intravenous crystalloid. The primary feasibility outcome is protocol adherence, defined as the proportion of randomized participants who receive the allocated route of administration without a major protocol deviation. The primary clinical outcome is the proportion of patients achieving the prescribed fluid volume during the ED stay, censored at 48 hours after randomization and analyzed using a noninferiority framework. Noninferiority of oral fluid therapy will be tested against the null hypothesis that the intravenous proportion exceeds the oral proportion by at least the noninferiority margin of 15 percentage points, using the difference in proportions with a 1-sided 97.5% CI (equivalent to a 2-sided 95% CI) from an exact proportion test. The sample size of 250 will provide 90% power at a 1-sided α of .025 under an assumed proportion of 85% in both arms.</p><p><strong>Results: </strong>The study was funded by the Region of Southern Denmark in May 2024. Recruitment began in October 2025 at 3 Danish EDs, and 85 participants have been recruited as of September 2026. Recruitment is projected to close in October 2026, with final 30-day follow-up projected for November 2026. No amendments to the protocol have been made. Results are expected to be published in summer 2027.</p><p><strong>Conclusions: </strong>This trial will evaluate whether a randomized trial comparing intravenous and oral fluid therapy is feasible in ED patients and whether oral fluid therapy can achieve prescribed fluid volumes comparable to those achieved with intr","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95459"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13669699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110157","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":"Exploring Perceived Barriers and Facilitators to Healthier and More Sustainable Dietary Behavior in 27 European Countries: Protocol for a Cross-Sectional Survey.","authors":"Anna Maria Murante, Federica Manca, Fabio Consalez, Chiara Chirilli, Luisa Torri, Anant Jani, Agustin Miranda, Eric Verger, Catalina Leon Gonzalez, Maria Piochi, Maria Giovanna Onorati, Susana Campos, Ana Teresa Ferreira Oliveira, Janas Harrington, Valeria Massei, Chiara Ferravante, Tim Smits, Yara Qutteina, Kabi Vanwinkelen, Annemarie Kapteijns, Leonie Barelds-Cramer, Aleksandra Różalska, Aditi Bunker, Till Bärnighausen","doi":"10.2196/91985","DOIUrl":"https://doi.org/10.2196/91985","url":null,"abstract":"<p><strong>Background: </strong>Food systems strongly affect human and environmental health. Across Europe, they often generate negative public health and environmental outcomes and contribute to inequalities in access to healthy, sustainable food. Addressing these challenges requires understanding the complex dynamics of the interaction of individual behavior within food systems, which involves a combination of internal mechanisms and external influences.</p><p><strong>Objective: </strong>This study, part of the FEAST project (Food Systems That Support Transitions to Healthy and Sustainable Diets), aims to increase understanding of how micro-, meso-, and macro-level factors shape Europeans' food preferences, purchasing, and consumption behaviors. It also explores differences across European regions and population subgroups.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted among 27,000 adults in 27 European countries across the 5 FEAST food regions (Anglo-Saxon, Central European, Scandinavian, Southern European, and Eastern European). In addition to the vulnerable groups (older adults; low-income or low-education people and those with health or disability conditions; families with minors, women, gender-diverse people, etc) that could be captured in the main survey, an additional sample of 400 vulnerable individuals from the Down syndrome (DS) community (including carers of people with DS) was expected to be involved in 5 European countries (Ireland, Italy, Portugal, Romania, and Scotland). To achieve the target of 1000 participants per country, the general population was recruited through a market-insights platform with extensive European coverage. Individuals with DS and their caregivers were recruited through national DS associations. Data were collected using an 88-item questionnaire covering dietary patterns, food-purchasing behavior, drivers and barriers to healthy and sustainable eating, perceived dietary sustainability, opinions on food policy options, and sociodemographic characteristics. The same questionnaire was administered to caregivers, whereas individuals with DS completed an adapted version addressing eating habits, food appearance, and food neophobia in an accessible format. Statistical analyses are being conducted to identify determinants of healthy and sustainable diets.</p><p><strong>Results: </strong>A total of 27,417 questionnaires were collected from the general population across 27 countries, together with 82 questionnaires from people with DS and 242 from caregivers. Expected findings will describe Europeans' food consumption habits, preferences, and purchasing behaviors, including those of vulnerable groups, and assess their alignment with planetary health diet principles. The study will also identify key barriers and facilitators to adopting healthier and more sustainable diets, as well as sources of nutritional information and attitudes toward food-related policies.</p><p><strong>Conclusions: </st","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e91985"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110035","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":"Fascial Manipulation Compared to Stretching for Rehabilitation of Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial.","authors":"Karin von Smitten-Stubb, Joachim Ring, Piia Haakana, Heikki Hurri, Mira Huusko, Ira Jeglinsky-Kankainen, Jyrki Kettunen, Juha-Pekka Kulmala, Taru Laakso, Tiina Lahtinen-Suopanki, Essi Marttinen Rossi, Helena Mäenpää, Tuula Niemelä, Mika Peltoniemi, Leena Ristolainen, Petri Salonen, Eva Teijonsalo, Nita Tolvanen","doi":"10.2196/92401","DOIUrl":"https://doi.org/10.2196/92401","url":null,"abstract":"<p><strong>Background: </strong>Maintaining and improving motor function is essential in the rehabilitation of children with cerebral palsy (CP). Stretching is traditionally used to prevent muscle tightness and contractures to improve movement patterns in children with CP. Fascial manipulation (FM) is an increasingly used manual therapy method for movement difficulties associated with CP. However, evidence for FM remains limited, and its benefits over conventional stretching are unclear. A pilot randomized controlled trial (RCT) is warranted to assess the feasibility and acceptability of a definitive trial comparing FM with stretching. This study protocol describes a pilot randomized controlled feasibility trial comparing FM and stretching in children with CP to inform the design and conduct of a future definitive RCT.</p><p><strong>Objective: </strong>The primary objective is to assess the feasibility and acceptability of the trial procedures and interventions. This includes evaluating recruitment and retention rates, intervention adherence, completion rates for outcome assessments, and the perceived impact of the interventions on children's daily functioning and participation. The secondary objective is to explore the preliminary acute and longitudinal effects of FM, compared with traditional stretching, on walking performance, gait biomechanics, joint mobility, and the variability in these outcome measures.</p><p><strong>Methods: </strong>This pilot RCT will include 20 children aged 7 to 14 years with spastic CP, randomized to an FM intervention group (n=10) and a stretching group (n=10). Both groups will receive 1 treatment session per week for 8 weeks. Feasibility and acceptability will be assessed using quantitative measures of recruitment and retention, intervention adherence, and completion of outcome assessments, complemented by semistructured interviews with caregivers and the children's regular physiotherapists to explore perceived changes in the children's daily functioning and participation, and their experiences of the interventions. Secondary outcomes include the 6-minute walk test (6MWT), walking metabolic cost, gait biomechanics, ankle spasticity, muscle activity, joint stiffness, and functional mobility in daily life. Acute outcomes will be assessed before and after the first intervention session, while longitudinal outcomes will be assessed at baseline and following the 8-week intervention period.</p><p><strong>Results: </strong>Recruitment of participants began in October 2024, with 3 additional participants required to reach the target sample size. Results are expected to be published in 2027.</p><p><strong>Conclusions: </strong>This pilot RCT will provide essential feasibility data and preliminary estimates of potential treatment effects to inform the design of a future adequately powered RCT. To our knowledge, evidence regarding the effects of FM on gait, mobility, and function in children with CP remains limited. This stud","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e92401"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110032","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":"Preoperative Carriage of Respiratory Viruses and Acute Respiratory Distress Syndrome After Cardiac Surgery: Protocol for the VIRUS-ATTAC Prospective Cohort Study.","authors":"Nicolas Nesseler, Adrien Bouglé, Bertrand Rozec, Nicolas Mongardon, Thomas Kerforne, Chloé Rousseau, Erwan Flécher, Jean-Philippe Verhoye, Mathieu Beaudeau, James Terriss Ross, Marie-Laure Gervais, Claire Fougerou-Leurent, Pierre Tattevin, Vincent Thibault, Célia Pilon, Charlotte Pronier, Alexandre Mansour","doi":"10.2196/103466","DOIUrl":"https://doi.org/10.2196/103466","url":null,"abstract":"<p><strong>Background: </strong>Cardiac surgery patients are at particular risk of postoperative acute respiratory distress syndrome (ARDS), with an estimated incidence of 5% to 10%. Cardiopulmonary bypass (CPB), ischemia-reperfusion injury, and blood product transfusions are well-recognized contributing factors. Asymptomatic carriage of respiratory viruses has been hypothesized to prime the lungs and potentiate ARDS development when combined with the pulmonary insults of cardiac surgery. However, no study has directly assessed the relationship between preoperative asymptomatic viral carriage and postoperative ARDS.</p><p><strong>Objective: </strong>The VIRUS-ATTAC study aims to determine whether asymptomatic carriage of influenza or other respiratory viruses is independently associated with postoperative ARDS following elective cardiac surgery under CPB.</p><p><strong>Methods: </strong>VIRUS-ATTAC is a prospective, multicenter, low-interventional clinical study conducted across 5 French university hospitals and sponsored by Rennes University Hospital. Adult patients scheduled for elective cardiac surgery under CPB are eligible. A nasopharyngeal flocked swab is collected at anesthesia induction and tested using a multiplex reverse transcription polymerase chain reaction assay detecting 16 respiratory viruses. Results are kept blinded to the clinical team. The primary outcome is ARDS within 7 postoperative days, defined using the Berlin criteria and adjudicated by an independent blinded committee. Secondary outcomes include reintubation, postoperative pulmonary complications, pneumonia, ventilator-free days, intensive care unit-free days, hospital-free days, and 28-day mortality. The primary analysis uses a causal inference framework with a directed acyclic graph for confounder selection and g-computation to estimate the average treatment effect of viral carriage on ARDS risk. A sample size of 1250 patients (including 250 asymptomatic influenza carriers) provides 80% power to detect a 5% absolute risk increase in ARDS (2-sided α=.05).</p><p><strong>Results: </strong>The VIRUS-ATTAC study received ethics approval from the Comité de Protection des Personnes Sud-Est VI, and recruitment was initiated in February 2021 across 5 French university hospitals. Data collection was completed on March 10, 2023. Of the 1258 patients assessed as eligible, 1204 provided written informed consent and were enrolled. The study database was locked on April 9, 2026. Statistical analysis began after database lock, and the results are expected to be reported in a separate publication in 2027.</p><p><strong>Conclusions: </strong>VIRUS-ATTAC is the first prospective multicenter study to directly evaluate the association between preoperative asymptomatic respiratory viral carriage and postoperative ARDS in cardiac surgery patients. If confirmed, this association would provide a rationale for evaluating preventive strategies, such as systematic preoperative vaccination or po","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e103466"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626548/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110190","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":"Economic Evaluation of a Digital Psychobehavioral Intervention for Chronic Inflammatory Skin Disease (MindMySkin): Protocol for a Trial-Based Cost-Effectiveness Analysis.","authors":"Ellie Choi, Sin Hui Neo, Phillip Phan, Stavros Petrou","doi":"10.2196/95215","DOIUrl":"10.2196/95215","url":null,"abstract":"<p><strong>Background: </strong>Digital mental health apps are increasingly available and used, yet the large majority lack clinical and economic evidence, limiting reimbursement support and the identification of high-value interventions. MindMySkin is a digital psychobehavioral mobile intervention co-designed with patients and guided by behavioral change frameworks to address the psychobehavioral determinants of symptom burden in chronic inflammatory skin diseases. The app comprises 74 modules targeting illness coherence, symptom management, and emotional and functional impairment and is currently being tested in a double-blind randomized controlled trial.</p><p><strong>Objective: </strong>This protocol prespecifies an economic evaluation plan conducted as a secondary analysis alongside the trial to assess the cost-effectiveness of MindMySkin within Singapore's health care system.</p><p><strong>Methods: </strong>The parent trial recruits English-speaking participants aged 16 years or older with psoriasis, eczema, or chronic urticaria across 3 sites in Singapore (target N=690; 2:1 allocation, 32-week follow-up). The active comparator is Healthy365, a general wellness app managed by the Singapore Health Promotion Board. The trial-based economic evaluation will adopt a health care system perspective as the primary analytic viewpoint. Resource costs will include intervention deployment and dermatology-related health care use. Indirect medical costs and work productivity losses will additionally be included in a sensitivity analysis conducted from a societal perspective. A cost-effectiveness analysis will use the Dermatology Life Quality Index, a dermatology-specific measure of health-related quality of life, while a cost-utility analysis will derive health utilities from the EQ-5D-5L to enable estimation of quality-adjusted life years. Incremental cost-effectiveness ratios and net monetary benefit will be estimated using intention-to-treat analyses with regression adjustment. Uncertainty will be explored using bootstrapping, deterministic sensitivity analyses, subgroup analyses, and scenario modeling. A Markov model-based extrapolation over 5 years will be undertaken if within-trial results suggest a high likelihood of cost-effectiveness.</p><p><strong>Results: </strong>Study funding is provided by the National Medical Research Council Clinical-Scientist Individual Research Grant New Investigator Grant (CS-IRG NIG; funded on June 5, 2024), and ethics approval has been obtained (2022/00751). Recruitment commenced in February 2026, and as of June 2026, a total of 46 participants have been enrolled. Economic data collection will be conducted concurrently with the parent trial, and the economic analysis is expected to commence following trial completion, which is anticipated in 2028.</p><p><strong>Conclusions: </strong>By embedding a health economic evaluation within a randomized controlled design and incorporating condition-sensitive outcome measures, ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95215"},"PeriodicalIF":1.6,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13622875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080476","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":"Eye Tracking-Based Evaluation of Auditory Spatial Attention in a Virtual Auditory Environment: Protocol for Development of a New Approach and Preliminary Validation.","authors":"Clémence Lelaumier, Franck Doidy, Baptiste Fruleux, Antoine Petroff, Valentin Bauer, Hervé Platel","doi":"10.2196/88231","DOIUrl":"10.2196/88231","url":null,"abstract":"<p><strong>Background: </strong>Auditory spatial attention (ASA) can be impaired in clinical populations and affects everyday activities, yet it remains understudied and lacks practical assessment tools for clinical use. However, recent technological advances have enabled the development of auditory virtual environments capable of engaging attentional networks while remaining compatible with clinical implementation and supporting the collection of objective physiological measures.</p><p><strong>Objective: </strong>This study aimed to address the lack of clinically applicable ASA assessments by developing a new assessment (phase 1) and supporting its future implementation in clinical practice through preliminary validation and user experience evaluation (phase 2).</p><p><strong>Methods: </strong>In phase 1, the assessment was developed through a multidisciplinary research committee involving clinicians and researchers, and was refined through pilot testing with 17 healthy participants. It uses an immersive auditory virtual environment and combines eye tracking, head tracking, and pupillometry. Phase 2 will consist of two successive studies: (1) 15 expert clinicians (neuropsychologists or speech therapists) will evaluate face and content validity, and user experience, and (2) 80 healthy adults will provide additional sources of validity evidence and user experience data. Participants will complete 5 steps of an ASA task, alternating habituation and measurement blocks, using either gaze orientation or head orientation as the response modality. Vocal targets will be presented with or without background sound in a dynamic binaural environment.</p><p><strong>Results: </strong>Study 1 will provide preliminary validity evidence based on face and content, together with user experience outcomes, including usability, satisfaction, and intention to use. Recruitment of participants began in November 2025 and was completed in January 2026. Data analysis is in progress, and the corresponding manuscript is expected to be submitted for publication during the winter of 2026-2027. Study 2 will provide preliminary validity evidence based on precision, face and content, response processes, internal structure, and fairness, together with user experience outcomes, including usability, satisfaction, and sense of presence. Recruitment of participants began in March 2026 and is expected to be completed in October 2026. As of July 2026, 48 participants had been enrolled. Completion of data analysis and submission of the corresponding manuscript are expected in winter 2027-2028.</p><p><strong>Conclusions: </strong>This validation study represents the first step toward developing a clinically applicable tool for assessing ASA. By combining immersive auditory technology with clinically feasible hardware, the proposed approach aims to provide a rapid and ecologically valid evaluation of ASA. Future studies will focus on formal psychometric validation, patient testing, and the ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e88231"},"PeriodicalIF":1.6,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623210/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080443","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":"Protocol for a Multimodal Investigation of Interoception in Adolescence and Testing Virtual Reality Interventions to Improve Interoceptive Impairments.","authors":"Nathan M Boyle, Sarah H Guo, Madison M Angelo, Ann S Choe, Liuyi Chen, Martin A Lindquist, Angela S Guarda, Kellie Lk Tamashiro, Kimberly R Smith, Joseph F McGuire","doi":"10.2196/103785","DOIUrl":"https://doi.org/10.2196/103785","url":null,"abstract":"<p><strong>Background: </strong>Psychiatric conditions predominantly emerge in adolescence and represent a leading cause of disability and morbidity worldwide. Interoceptive dysfunction has been implicated in the development and maintenance of several psychiatric conditions and is characterized by disruptions in the perception and interpretation of internal bodily signals. Despite its recognized importance, interoception has not been well-characterized in adolescence-a key developmental period marked by profound neurobiological, physiological, and psychosocial change. Consequently, the precise role of interoceptive dysfunction in the onset and progression of psychiatric disorders remains unclear. Thus, research is needed to characterize interoception in adolescence, elucidate its contributions to psychiatric conditions, and determine interventions that effectively address interoceptive impairments. Importantly, such interventions should be designed with future dissemination in mind-prioritizing accessibility, scalability, and standardization. Virtual reality (VR) represents one promising approach to deliver therapeutic skills that target interoception, which also engages multiple sensory systems (e.g., visual, auditory, bodily signals) during intervention delivery. These immersive and controllable experiences provide a unique platform to systematically target interoceptive processes when delivering evidence-based therapeutic strategies such as mindfulness and relaxation training. By enabling standardized delivery and precise manipulation of multisensory experiences, VR may overcome key barriers to the dissemination and scalability of traditional approaches to intervention.</p><p><strong>Objective: </strong>This project conducts a multimodal assessment of interoception and related learning processes in adolescence and tests whether two single session interventions (SSI) delivered in VR improve interoceptive functioning.</p><p><strong>Methods: </strong>Ninety adolescents (60 with psychiatric disorders associated with interoceptive impairments and 30 unaffected healthy controls) between 12 and 17 years of age will complete a structured diagnostic clinical interview and an assessment battery of questionnaires to characterize the presence of psychiatric disorders, severity of psychiatric symptoms, interoceptive awareness, and related constructs (e.g., sleep, distress tolerance, mindfulness, self-efficacy). Youth will complete validated tasks to assess interoceptive functioning (e.g., cardiac interoceptive accuracy, interoceptive awareness of heart rate) and two associative learning mechanisms (e.g., aversive conditioning and reward learning). While cardiac interoception will serve as the primary outcome measure of interoceptive functioning, secondary outcomes of other systems will be explored (e.g., temporal coupling between gastric rhythms and neural activity). Finally, participants will complete two SSIs in VR (i.e., mindfulness, relaxation training","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080531","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":"Effects of Rhythm Control versus Rate Control on Atrial Fibrillation and Frailty Development in Older Patients: Protocol for the Cardioversion of Atrial Fibrillation and Frailty in the Elderly (CAFFE) Study, an Observational, Prospective Cohort Study.","authors":"Elisa Berni, Veronica De Angelis, Emanuele Santamaria, Alessandro Mengozzi, Claudia Di Serio, Giulia Spanalatte, Michele Biagioli, Arianna Tariello, Marta Niccolini, Camilla Cagnoni, Djullye Miduri Da Silva Nakano, Giada Alla Viligiardi, Marco Capacci, Andrea Ungar, Giancarlo La Marca, Igor Diemberger, Agostino Virdis, Stefano Fumagalli","doi":"10.2196/92572","DOIUrl":"10.2196/92572","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF), highly prevalent in older individuals, is associated with frailty and disability. AF therapy is based on rhythm control (RhythmC) to restore sinus rhythm or rate control (RateC) to lower the heart rate. Published guidelines do not indicate a preference for one over the other for older people.</p><p><strong>Objective: </strong>This study aims to evaluate whether RhythmC is more effective than RateC in hindering the progression of frailty and disability.</p><p><strong>Methods: </strong>The Cardioversion of Atrial Fibrillation and Frailty in the Elderly (CAFFE) study is a prospective, multicenter, observational cohort study that includes 4 groups of patients: (1) adults age 75 years or older undergoing RhythmC treatment; (2) adults aged 65 to 74 years undergoing RhythmC treatment; (3) adults 65 years or older undergoing RateC treatment; and (4) adults 65 years or older without overt chronic conditions as the control group (n=40 in each group). At baseline, all participants will undergo a Comprehensive Geriatric Assessment (CGA) and analyses of inflammation and metabolomics. At home, a device will evaluate each participant's heart rhythm, activity profile, and sleep. After 1 month, the CGA will be repeated.</p><p><strong>Results: </strong>The CAFFE study was funded as a Research Project of National Interest by the Italian Ministry of University and Research (October 2023). Ethical committee final approval was given in June 2024. In October 2025, the coordinating center had enrolled 31 of 40 patients with AF (mean age 78, SD 9 years; 8 [25.8%] women; mean CHA₂DS₂-VA score 4.2, SD 1.2; 13 [43.3%] robust participants). All centers are now completing the enrollment (103/160 participants), and the analysis of inflammatory mediators has started. The results are expected to be published in summer 2027.</p><p><strong>Conclusions: </strong>The CAFFE study will evaluate the effectiveness of AF management strategies in older patients. If RhythmC can slow the progression of frailty and disability, specific clinical trials should more definitively address this knowledge gap.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e92572"},"PeriodicalIF":1.6,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13621886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080507","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 a Mental Health Care App-Based Fatigue Management Program for Patients With Inflammatory Bowel Disease in Remission: Protocol for a Randomized Controlled Trial.","authors":"Makoto Tanaka, Sayaka Wakai, Kayoko Sakagami, Aki Kawakami, Hikari N Takashina, Jeongae Kang, Masakazu Nagahori, Hiroaki Ito","doi":"10.2196/96593","DOIUrl":"10.2196/96593","url":null,"abstract":"<p><strong>Background: </strong>Fatigue remains a major unresolved issue affecting the quality of life of patients with inflammatory bowel disease (IBD), even during clinical remission. Scalable psychological approaches are needed to support effective fatigue management.</p><p><strong>Objective: </strong>The aim of this study is to evaluate the effectiveness of a multicomponent mobile cognitive behavioral intervention package for fatigue management among patients with IBD in remission and to explore factors associated with engagement with the intervention and its effectiveness.</p><p><strong>Methods: </strong>This was an open-label, waitlist-controlled randomized controlled trial. Eligible participants were adults (≥18 years) diagnosed with Crohn disease or ulcerative colitis who met remission criteria and had at least mild fatigue. Participants were randomized 1:1 using stratified block randomization based on disease type, sex, and baseline fatigue severity. The intervention was a multicomponent mobile intervention package centered on a 7-week cognitive behavioral therapy-based educational course, supplemented by adjunctive support messages. The primary outcome was fatigue, measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and the secondary outcome was self-efficacy, measured using the 13-item Inflammatory Bowel Disease Self-Efficacy Scale Short Form (IBD-SES13). A sample size of 175 participants per group was required.</p><p><strong>Results: </strong>Recruitment of participants began on July 28, 2025, and ended on February 24, 2026. A total of 502 patients with IBD in clinical remission agreed to participate and were assessed for eligibility. Among them, 351 met the eligibility criteria and were randomized, while 151 (30.0%) had FACIT-F scores of 40 or higher and were excluded. Currently, follow-up is ongoing. The clinical outcome data will be analyzed after follow-up is completed, and the results are expected to be submitted for publication in 2027.</p><p><strong>Conclusions: </strong>This study may contribute valuable knowledge regarding participant engagement and the potential impact of a multicomponent mobile cognitive behavioral intervention package on fatigue in patients with IBD. The findings will support future refinement of the intervention and inform large-scale evaluations and implementation efforts.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e96593"},"PeriodicalIF":1.6,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13618207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149069451","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":"Healthy Trust and Pandemic Readiness in the Context of Messenger RNA Vaccines: Protocol for a Sequential Deliberative Dialogue Study.","authors":"Katrina Plamondon, Rodrigo Curty Pereira, Angeli Rawat","doi":"10.2196/91534","DOIUrl":"10.2196/91534","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pandemics threaten economies, security, and public health, requiring strong global and local collaboration and coordination. Public receptivity to emergent vaccine technologies is essential to pandemic readiness. Although messenger RNA (mRNA) vaccines offer rapid adaptability and hold promise, their use during the COVID-19 pandemic was met with polarizing debates that raise questions about the conditions needed to support acceptable and equitable use of new vaccines.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This deliberative dialogue study aims to generate consensus on how to ensure informed, accessible public engagement and strengthen public trust in a climate of divisiveness and misinformation, disinformation, and malinformation. Using mRNA vaccines as a case study, the project's specific research objective is to seek insights into what people believe is needed for public understanding, equitable access, and acceptance of emerging vaccine technologies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using a sequential deliberative dialogue design, this study invites individuals with significant influence on pandemic readiness and those most likely to be disproportionately affected by related decisions into reflective, conversational, workshop-style online events and self-led dialogues. Dialogues and guiding questions are informed by a knowledge synthesis on what is unknown about mRNA vaccine public sentiments based on a rapid review, an environmental scan, consultations with experts across sectors, and ongoing updates from the dialogues. Data will be analyzed in situ in an iterative and collaborative synthesis of general agreements between dialogue contributors in response to guiding questions and emerging themes. Dialogue reports will be drafted by the research team based on observational notes, transcripts, and video recordings and reviewed by contributors. In summative dialogues, the research team will present main threads of dialogue, responding to research objectives and newly identified knowledge gaps and collecting input to inform dialogue outputs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in May 2025. As of June 2026, we have conducted 10 deliberative dialogues and supported 1 self-led dialogue, engaging 77 contributors across sectors and disciplines. We held 2 summative dialogues with 18 attendees, where we presented the main threads of dialogue as identified by the research team through collaborative analysis. We have started incorporating input from closing dialogues into the final reports and expect to publish the results in the second half of 2026, both as lay-language reports and peer-reviewed manuscripts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This protocol outlines a consensus-building process capable of deepening the understanding of vaccine hesitancy and strengthening pandemic readiness and public trust in Canada. Dialogues are expected to provide general agreements on how to enhance science and health litera","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e91534"},"PeriodicalIF":1.6,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13614397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149061278","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}