Wubin Xie, Sabrina Ahmed, Ali Ahsan, Ananya Gupta, Anais Masako Keenan, Tanmoy Sarker, Fahmida Akter, Aysha Anan, Md Mokbul Hossain, Zahidul Quayyum, Ahm Enayet Hussain, Robed Amin, Imran Ahmed Chowdhury, Mithila Faruque, Sohel Reza Choudhury, Ian Y Goon, Fred Hersch, Lora L Sabin, Brian Oldenburg, John Chambers, Malay Kanti Mridha
Background: Hypertension and diabetes are very common, interrelated chronic conditions. Awareness, diagnosis, treatment, and control rates of these conditions remain low, and access to quality care-particularly in rural areas-is a persistent challenge in many low- and middle-income countries. Strengthening primary health care, including the use of digital tools, is important to improve management of these chronic conditions.
Objective: This study aims to assess the implementation and effectiveness of a multicomponent, decentralized primary care model in comparison with a digital health-only intervention and usual care in rural Bangladesh.
Methods: The study applies a type 2 hybrid effectiveness-implementation design, using a 3-arm quasi-experimental approach, comprising 2 intervention arms and 1 usual care comparison arm. The study is being conducted across 3 subdistricts in the Dinajpur district, Rangpur division, northern Bangladesh. Primary outcomes include blood pressure and blood glucose control rates, assessed by population-based repeated cross-sectional surveys with independent samples, supplemented by facility-based prospective cohort data. Additionally, a mixed methods process evaluation is being conducted to capture the quantity, fidelity, adaptations, reach, and context of the interventions.
Results: The baseline community survey was conducted between January and March 2024, enrolling 6849 participants distributed across 3 arms: 2262 in usual care, 2287 in the digital-only arm, and 2300 in the multicomponent intervention arm. Participants had a mean age of 55.9 (SD 10.6) years with equal sex distribution (female: 3432/6849, 50.1%). Educational attainment was low, with 39.5% (2704/6849) of participants having no formal schooling and only 12.1% (917/6849) attaining secondary or higher education. The majority (6316/6849, 92.2%) reported being either self-employed or homemakers. The age-standardized baseline blood pressure control rate among all participants with hypertension was 10.2% overall, while the glycemic control rate among those with diabetes was 14.9%. Awareness and treatment rates for hypertension were 35.3% and 23.0%, respectively, compared to 60.7% and 34.5% for diabetes.
Conclusions: The study findings will provide critical evidence on scalable models for decentralized noncommunicable disease care and will have important implications for improving the management of hypertension and diabetes in Bangladesh and similar low-resource settings globally.
{"title":"Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh Through Digital Technology Supported Decentralized Primary Care: Study Protocol and Baseline Results for a Hybrid Effectiveness-Implementation Trial.","authors":"Wubin Xie, Sabrina Ahmed, Ali Ahsan, Ananya Gupta, Anais Masako Keenan, Tanmoy Sarker, Fahmida Akter, Aysha Anan, Md Mokbul Hossain, Zahidul Quayyum, Ahm Enayet Hussain, Robed Amin, Imran Ahmed Chowdhury, Mithila Faruque, Sohel Reza Choudhury, Ian Y Goon, Fred Hersch, Lora L Sabin, Brian Oldenburg, John Chambers, Malay Kanti Mridha","doi":"10.2196/71696","DOIUrl":"10.2196/71696","url":null,"abstract":"<p><strong>Background: </strong>Hypertension and diabetes are very common, interrelated chronic conditions. Awareness, diagnosis, treatment, and control rates of these conditions remain low, and access to quality care-particularly in rural areas-is a persistent challenge in many low- and middle-income countries. Strengthening primary health care, including the use of digital tools, is important to improve management of these chronic conditions.</p><p><strong>Objective: </strong>This study aims to assess the implementation and effectiveness of a multicomponent, decentralized primary care model in comparison with a digital health-only intervention and usual care in rural Bangladesh.</p><p><strong>Methods: </strong>The study applies a type 2 hybrid effectiveness-implementation design, using a 3-arm quasi-experimental approach, comprising 2 intervention arms and 1 usual care comparison arm. The study is being conducted across 3 subdistricts in the Dinajpur district, Rangpur division, northern Bangladesh. Primary outcomes include blood pressure and blood glucose control rates, assessed by population-based repeated cross-sectional surveys with independent samples, supplemented by facility-based prospective cohort data. Additionally, a mixed methods process evaluation is being conducted to capture the quantity, fidelity, adaptations, reach, and context of the interventions.</p><p><strong>Results: </strong>The baseline community survey was conducted between January and March 2024, enrolling 6849 participants distributed across 3 arms: 2262 in usual care, 2287 in the digital-only arm, and 2300 in the multicomponent intervention arm. Participants had a mean age of 55.9 (SD 10.6) years with equal sex distribution (female: 3432/6849, 50.1%). Educational attainment was low, with 39.5% (2704/6849) of participants having no formal schooling and only 12.1% (917/6849) attaining secondary or higher education. The majority (6316/6849, 92.2%) reported being either self-employed or homemakers. The age-standardized baseline blood pressure control rate among all participants with hypertension was 10.2% overall, while the glycemic control rate among those with diabetes was 14.9%. Awareness and treatment rates for hypertension were 35.3% and 23.0%, respectively, compared to 60.7% and 34.5% for diabetes.</p><p><strong>Conclusions: </strong>The study findings will provide critical evidence on scalable models for decentralized noncommunicable disease care and will have important implications for improving the management of hypertension and diabetes in Bangladesh and similar low-resource settings globally.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e71696"},"PeriodicalIF":1.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12863458/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146105475","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}
Qing Wang, Mimaika Luluina Ginting, Ezra Ho, Siew Fong Goh, Jonathan Gao, Woan Shin Tan, Yew Yoong Ding, Wei Liang David Ng, Jonathan Choon Aik Ng, Sing Cheer Kwek, Richard Jor Yeong Hui, Zhen Sinead Wang, Chirk Jenn Ng, Grace Sum
<p><strong>Background: </strong>The World Health Organization (WHO) public health framework for healthy aging advocates for action on the trajectories of intrinsic capacity (IC) across a person's life course to optimize functional ability. While the WHO integrated care for older people (ICOPE) framework provides guidance on a systematic care pathway on IC screening, clinical assessment to clarify IC deficits and person-centered management, its real-world implementation and evaluation remain nascent. The Intrinsic Capacity Promotion in Primary Care for the Frail (IMPACTFrail) program for mildly frail older adults in Singapore's primary care seeks to operationalize WHO ICOPE and national strategies.</p><p><strong>Objective: </strong>The objectives of this study are (1) the co-development of IMPACTFrail's core functions and its delivery, as well as selecting, specifying and operationalizing implementation strategies to address anticipated barriers and leverage anticipated facilitators and (2) to conduct a feasibility assessment on the readiness to scale to a main study.</p><p><strong>Methods: </strong>For the first objective, the co-development process is guided by the United Kingdom Medical Research Council's (MRC's) framework for developing and evaluating complex interventions and the Framework of Actions for Intervention Development (FAID). The identification of contextual barriers and facilitators will draw on the updated Consolidated Framework for Implementation Research (CFIR) and its Outcomes Addendum. To identify individual-level behavior change barriers, we will extend this framework using the Theoretical Domains Framework (TDF). The Expert Recommendations for Implementing Change (ERIC) taxonomy guided our selection and development of implementation strategies. The collaboration involves implementation researchers, clinic leadership, frontline health care providers, and older adults. A 12-month, single-arm feasibility study will recruit 180 older adults aged 60 years and older with mild frailty (Clinical Frailty Scale score 4-5) across 5 public primary care clinics. Feasibility criteria include implementation, acceptability, practicality, and adaptability. We will narratively triangulate findings across study components to enhance the validity and credibility of the feasibility study, including (1) process evaluation using quantitative process indicators, (2) qualitative study to elicit barriers and facilitators to feasibility, sustainability and scalability, and to assess the attribution of the selected implementation strategies to implementation outcomes, (3) cost analysis, and (4) program description.</p><p><strong>Results: </strong>The study was funded in September 2024. Data collection for the feasibility assessment commenced in April 2025 and will conclude by March 2026. As of manuscript submission, 98 participants have been recruited across 5 sites. Recruitment, data collection, and analysis are ongoing. Publication of results is exp
{"title":"Development and Feasibility Assessment of an Intrinsic Capacity Program in Primary Care: Protocol for an Implementation Science Approach.","authors":"Qing Wang, Mimaika Luluina Ginting, Ezra Ho, Siew Fong Goh, Jonathan Gao, Woan Shin Tan, Yew Yoong Ding, Wei Liang David Ng, Jonathan Choon Aik Ng, Sing Cheer Kwek, Richard Jor Yeong Hui, Zhen Sinead Wang, Chirk Jenn Ng, Grace Sum","doi":"10.2196/84257","DOIUrl":"https://doi.org/10.2196/84257","url":null,"abstract":"<p><strong>Background: </strong>The World Health Organization (WHO) public health framework for healthy aging advocates for action on the trajectories of intrinsic capacity (IC) across a person's life course to optimize functional ability. While the WHO integrated care for older people (ICOPE) framework provides guidance on a systematic care pathway on IC screening, clinical assessment to clarify IC deficits and person-centered management, its real-world implementation and evaluation remain nascent. The Intrinsic Capacity Promotion in Primary Care for the Frail (IMPACTFrail) program for mildly frail older adults in Singapore's primary care seeks to operationalize WHO ICOPE and national strategies.</p><p><strong>Objective: </strong>The objectives of this study are (1) the co-development of IMPACTFrail's core functions and its delivery, as well as selecting, specifying and operationalizing implementation strategies to address anticipated barriers and leverage anticipated facilitators and (2) to conduct a feasibility assessment on the readiness to scale to a main study.</p><p><strong>Methods: </strong>For the first objective, the co-development process is guided by the United Kingdom Medical Research Council's (MRC's) framework for developing and evaluating complex interventions and the Framework of Actions for Intervention Development (FAID). The identification of contextual barriers and facilitators will draw on the updated Consolidated Framework for Implementation Research (CFIR) and its Outcomes Addendum. To identify individual-level behavior change barriers, we will extend this framework using the Theoretical Domains Framework (TDF). The Expert Recommendations for Implementing Change (ERIC) taxonomy guided our selection and development of implementation strategies. The collaboration involves implementation researchers, clinic leadership, frontline health care providers, and older adults. A 12-month, single-arm feasibility study will recruit 180 older adults aged 60 years and older with mild frailty (Clinical Frailty Scale score 4-5) across 5 public primary care clinics. Feasibility criteria include implementation, acceptability, practicality, and adaptability. We will narratively triangulate findings across study components to enhance the validity and credibility of the feasibility study, including (1) process evaluation using quantitative process indicators, (2) qualitative study to elicit barriers and facilitators to feasibility, sustainability and scalability, and to assess the attribution of the selected implementation strategies to implementation outcomes, (3) cost analysis, and (4) program description.</p><p><strong>Results: </strong>The study was funded in September 2024. Data collection for the feasibility assessment commenced in April 2025 and will conclude by March 2026. As of manuscript submission, 98 participants have been recruited across 5 sites. Recruitment, data collection, and analysis are ongoing. Publication of results is exp","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e84257"},"PeriodicalIF":1.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146105498","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}
<p><strong>Background: </strong>Mild cognitive impairment and early dementia (MCI-ED) are frequently unrecognized in routine care, particularly in home health care (HHC), where clinical decisions are made under time constraints and cognitive status may be incompletely documented. Federally mandated HHC assessments, such as the Outcome and Assessment Information Set (OASIS), capture health and functional status but may miss subtle early cognitive changes. Speech, language, and interactional patterns during routine patient-nurse communication, together with information embedded in unstructured clinical notes, may provide complementary signals for earlier identification.</p><p><strong>Objective: </strong>This protocol describes the development and evaluation of a multimodal screening approach for identifying MCI-ED in HHC by integrating (1) speech and interaction features from routine patient-nurse encounters (verbal communication), (2) large language model-based extraction of MCI-ED-related information from HHC notes and encounter transcripts, and (3) structured variables from OASIS.</p><p><strong>Methods: </strong>This ongoing cross-sectional case-control study is being conducted in collaboration with VNS Health (formerly Visiting Nurse Service of New York). Eligible participants are adults aged ≥60 years receiving HHC services. Case/control assignment uses a 2-stage process: electronic health record (EHR) prescreening followed by clinician-reviewed cognitive assessment (Montreal Cognitive Assessment and Clinical Dementia Rating) for consented participants without an existing mild cognitive impairment diagnosis. For Aim 1, each participant contributes 3 audio-recorded routine patient-nurse encounters linked to EHR data, including OASIS and free-text clinical notes. Aim 1 extracts acoustic, linguistic, emotional, and interactional features from patient-nurse verbal communication. Aim 2 uses a schema-guided large language model pipeline to extract and normalize MCI-ED-related symptoms, lifestyle risk factors, and communication deficits from HHC notes and encounter transcripts, supported by a human-annotated gold-standard dataset. Aim 3 integrates speech, extracted text variables, and OASIS predictors using supervised machine learning with stratified nested cross-validation; evaluation will include discrimination, calibration, and subgroup performance checks across race, sex, and age.</p><p><strong>Results: </strong>Between February 2024 and July 2025, a total of 114 HHC patients completed study-administered cognitive assessments and were classified as 55 MCI-ED cases and 59 cognitively normal controls. Audio-recorded patient-nurse encounters had a median duration of 19 (IQR 12-23) minutes and a median of 56 (IQR 31-80) utterances per encounter; nurses contributed more words than patients (median 842, IQR 461-1218 vs median 589, IQR 303-960). In exploratory feasibility analyses, multimodal models integrating speech, interactional features, and struct
{"title":"Developing a Multimodal Screening Algorithm for Mild Cognitive Impairment and Early Dementia in Home Health Care: Protocol for a Cross-Sectional Case-Control Study Using Speech Analysis, Large Language Models, and Electronic Health Records.","authors":"Maryam Zolnoori","doi":"10.2196/82731","DOIUrl":"https://doi.org/10.2196/82731","url":null,"abstract":"<p><strong>Background: </strong>Mild cognitive impairment and early dementia (MCI-ED) are frequently unrecognized in routine care, particularly in home health care (HHC), where clinical decisions are made under time constraints and cognitive status may be incompletely documented. Federally mandated HHC assessments, such as the Outcome and Assessment Information Set (OASIS), capture health and functional status but may miss subtle early cognitive changes. Speech, language, and interactional patterns during routine patient-nurse communication, together with information embedded in unstructured clinical notes, may provide complementary signals for earlier identification.</p><p><strong>Objective: </strong>This protocol describes the development and evaluation of a multimodal screening approach for identifying MCI-ED in HHC by integrating (1) speech and interaction features from routine patient-nurse encounters (verbal communication), (2) large language model-based extraction of MCI-ED-related information from HHC notes and encounter transcripts, and (3) structured variables from OASIS.</p><p><strong>Methods: </strong>This ongoing cross-sectional case-control study is being conducted in collaboration with VNS Health (formerly Visiting Nurse Service of New York). Eligible participants are adults aged ≥60 years receiving HHC services. Case/control assignment uses a 2-stage process: electronic health record (EHR) prescreening followed by clinician-reviewed cognitive assessment (Montreal Cognitive Assessment and Clinical Dementia Rating) for consented participants without an existing mild cognitive impairment diagnosis. For Aim 1, each participant contributes 3 audio-recorded routine patient-nurse encounters linked to EHR data, including OASIS and free-text clinical notes. Aim 1 extracts acoustic, linguistic, emotional, and interactional features from patient-nurse verbal communication. Aim 2 uses a schema-guided large language model pipeline to extract and normalize MCI-ED-related symptoms, lifestyle risk factors, and communication deficits from HHC notes and encounter transcripts, supported by a human-annotated gold-standard dataset. Aim 3 integrates speech, extracted text variables, and OASIS predictors using supervised machine learning with stratified nested cross-validation; evaluation will include discrimination, calibration, and subgroup performance checks across race, sex, and age.</p><p><strong>Results: </strong>Between February 2024 and July 2025, a total of 114 HHC patients completed study-administered cognitive assessments and were classified as 55 MCI-ED cases and 59 cognitively normal controls. Audio-recorded patient-nurse encounters had a median duration of 19 (IQR 12-23) minutes and a median of 56 (IQR 31-80) utterances per encounter; nurses contributed more words than patients (median 842, IQR 461-1218 vs median 589, IQR 303-960). In exploratory feasibility analyses, multimodal models integrating speech, interactional features, and struct","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82731"},"PeriodicalIF":1.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146105432","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}
Tahreem Ghazal Siddiqui, Maria Torheim Bjelkarøy, Tone Breines Simonsen, Maria Lie Selle, Christofer Lundqvist
Background: Older patients are frequent users of Z-hypnotics despite consensus recommendations against extended use. Inappropriate Z-hypnotic use among older patients is frequently reported, posing risks of side effects and dependence. Interventions have been mainly at the population level and through prescription regulations. There are few instruments helping general practitioners (GPs) deal with inappropriate use among individual patients.
Objective: Through a randomized controlled trial (RCT), we aim to test the effectiveness of a behavioral brief intervention (BI) method used by trained GPs for reducing inappropriate Z-hypnotic use among their patients.
Methods: We will conduct a double-blind RCT with a single crossover. Patients (aged >60 years) on participating GPs' lists who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders, and can provide valid informed consent are eligible. GPs randomized to the BI arm will be trained to administer the BI, and those randomized to business as usual (BAU) will not receive training. GPs' patient lists will be screened for inappropriate Z-hypnotic users through an electronic questionnaire. The GP will be informed of patients who should be given an appointment and administered the BI. Untrained GPs will continue BAU. Randomization-blinded outcome evaluation will be conducted at 6 weeks, 6 months, and 1 year in both the study groups.
Results: The main outcome is the proportion of patients with inappropriate Z-hypnotic use, comparing BI versus BAU, after 6 weeks. Secondary outcomes are cognitive function, pain, self-reported sleep evaluation, sleep efficiency (actigraphy) and quality of life, and change compared to baseline. We will also report on the characteristics of the screened GP patient population. Other variables are other medication use or polypharmacy, anxiety and depression, severity of dependence, and mortality.
Conclusions: If RCT-level evidence demonstrates the effectiveness of the BI for reducing inappropriate Z-hypnotic use among older patients without worsening of secondary outcomes, this could be a simple, transferable intervention to implement on a larger scale among GPs, other physicians, and health workers.
International registered report identifier (irrid): DERR1-10.2196/75670.
{"title":"Brief Intervention for Discontinuing Inappropriate Z-Hypnotic Use Among Older Patients in Primary Care: Protocol for a Cluster Randomized Controlled Trial With a Single Crossover.","authors":"Tahreem Ghazal Siddiqui, Maria Torheim Bjelkarøy, Tone Breines Simonsen, Maria Lie Selle, Christofer Lundqvist","doi":"10.2196/75670","DOIUrl":"https://doi.org/10.2196/75670","url":null,"abstract":"<p><strong>Background: </strong>Older patients are frequent users of Z-hypnotics despite consensus recommendations against extended use. Inappropriate Z-hypnotic use among older patients is frequently reported, posing risks of side effects and dependence. Interventions have been mainly at the population level and through prescription regulations. There are few instruments helping general practitioners (GPs) deal with inappropriate use among individual patients.</p><p><strong>Objective: </strong>Through a randomized controlled trial (RCT), we aim to test the effectiveness of a behavioral brief intervention (BI) method used by trained GPs for reducing inappropriate Z-hypnotic use among their patients.</p><p><strong>Methods: </strong>We will conduct a double-blind RCT with a single crossover. Patients (aged >60 years) on participating GPs' lists who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders, and can provide valid informed consent are eligible. GPs randomized to the BI arm will be trained to administer the BI, and those randomized to business as usual (BAU) will not receive training. GPs' patient lists will be screened for inappropriate Z-hypnotic users through an electronic questionnaire. The GP will be informed of patients who should be given an appointment and administered the BI. Untrained GPs will continue BAU. Randomization-blinded outcome evaluation will be conducted at 6 weeks, 6 months, and 1 year in both the study groups.</p><p><strong>Results: </strong>The main outcome is the proportion of patients with inappropriate Z-hypnotic use, comparing BI versus BAU, after 6 weeks. Secondary outcomes are cognitive function, pain, self-reported sleep evaluation, sleep efficiency (actigraphy) and quality of life, and change compared to baseline. We will also report on the characteristics of the screened GP patient population. Other variables are other medication use or polypharmacy, anxiety and depression, severity of dependence, and mortality.</p><p><strong>Conclusions: </strong>If RCT-level evidence demonstrates the effectiveness of the BI for reducing inappropriate Z-hypnotic use among older patients without worsening of secondary outcomes, this could be a simple, transferable intervention to implement on a larger scale among GPs, other physicians, and health workers.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/75670.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e75670"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093171","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}
Fritz Sterr, Lydia Bauernfeind, Christian Rester, Sabine Metzing, Rebecca Palm
Background: Worldwide, mechanical ventilation and ventilator weaning have been widely researched. Nevertheless, rates of weaning failure remain high. According to the Medical Research Council framework, ventilator weaning is a complex intervention. While there are various guidelines on this, there is no abstract theoretical understanding that organizes the interventions, outcomes, and their contexts.
Objective: This study aims to explore the interconnectedness of interventions, outcomes, and context in ventilator weaning of adult intensive care patients.
Methods: Using the approach of Funnell and Rogers, we develop a program theory for ventilator weaning in a multimethod study comprising 2 main steps. First, 3 literature reviews on interventions and outcomes, predictors of weaning failure, and patients' experiences were triangulated with stakeholder conversations. Using abduction, we then developed an initial program theory. Second, the initial theory will be revised in an iterative process. To this end, semistructured group discussions and workshops will be conducted, followed by a deductive thematic analysis and adaptation of our theory. This process will be repeated until stakeholder statements and data analyses are congruent with the program theory.
Results: The initial program theory developed in step 1 is presented in this protocol and serves as the basis for review and refinement in step 2. The results of this iterative process and the final program theory are expected in 2026.
Conclusions: Following the Medical Research Council framework, a program theory on ventilator weaning will be developed in this study. This may enable a differentiated understanding of ventilator weaning and more sustainable and comprehensive research. The program theory emphasizes the interdisciplinary nature of ventilator weaning and supports health care professionals in combining interventions appropriately and evaluating relevant outcomes.
Trial registration: Open Science Framework YGJ3T; https://doi.org/10.17605/OSF.IO/YGJ3T.
International registered report identifier (irrid): DERR1-10.2196/83342.
{"title":"Developing a Program Theory on Ventilator Weaning in Adult Intensive Care: Protocol for a Multimethods Study.","authors":"Fritz Sterr, Lydia Bauernfeind, Christian Rester, Sabine Metzing, Rebecca Palm","doi":"10.2196/83342","DOIUrl":"10.2196/83342","url":null,"abstract":"<p><strong>Background: </strong>Worldwide, mechanical ventilation and ventilator weaning have been widely researched. Nevertheless, rates of weaning failure remain high. According to the Medical Research Council framework, ventilator weaning is a complex intervention. While there are various guidelines on this, there is no abstract theoretical understanding that organizes the interventions, outcomes, and their contexts.</p><p><strong>Objective: </strong>This study aims to explore the interconnectedness of interventions, outcomes, and context in ventilator weaning of adult intensive care patients.</p><p><strong>Methods: </strong>Using the approach of Funnell and Rogers, we develop a program theory for ventilator weaning in a multimethod study comprising 2 main steps. First, 3 literature reviews on interventions and outcomes, predictors of weaning failure, and patients' experiences were triangulated with stakeholder conversations. Using abduction, we then developed an initial program theory. Second, the initial theory will be revised in an iterative process. To this end, semistructured group discussions and workshops will be conducted, followed by a deductive thematic analysis and adaptation of our theory. This process will be repeated until stakeholder statements and data analyses are congruent with the program theory.</p><p><strong>Results: </strong>The initial program theory developed in step 1 is presented in this protocol and serves as the basis for review and refinement in step 2. The results of this iterative process and the final program theory are expected in 2026.</p><p><strong>Conclusions: </strong>Following the Medical Research Council framework, a program theory on ventilator weaning will be developed in this study. This may enable a differentiated understanding of ventilator weaning and more sustainable and comprehensive research. The program theory emphasizes the interdisciplinary nature of ventilator weaning and supports health care professionals in combining interventions appropriately and evaluating relevant outcomes.</p><p><strong>Trial registration: </strong>Open Science Framework YGJ3T; https://doi.org/10.17605/OSF.IO/YGJ3T.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/83342.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e83342"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146085813","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}
<p><strong>Background: </strong>Health literacy, defined as the ability to obtain, understand, evaluate, and use health information, influences health behaviors and outcomes. Low health literacy (LHL) is associated with misunderstandings of treatment instructions, poor adherence, and inadequate preventive behaviors, all of which contribute to health disparities. Although universal precautions such as plain language and the teach-back method are recommended, recent studies indicate that these measures alone cannot fully address the challenges faced by patients with LHL. Previous qualitative studies have examined psychosocial processes through which shame and concealment shape patient-provider communication; however, these findings remain fragmented across settings and disciplines, and no scoping or systematic review has yet synthesized this evidence.</p><p><strong>Objective: </strong>This review aims to map how patients with LHL experience shame and concealment, how health care providers' behaviors and communication influence these experiences, and how these processes affect patient-provider communication and care. It also seeks to identify strategies to reduce the impact of shame and concealment in clinical practice.</p><p><strong>Methods: </strong>This review will be conducted and reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. PubMed, MEDLINE, CINAHL, PsycInfo, Web of Science, and Academic Search Complete will be searched using terms related to health literacy, patient-provider communication, and qualitative research. Qualitative and mixed methods studies with qualitative findings will be included, and quantitative-only studies will be excluded. The participants may include patients, health care providers, or both. Data extraction will include specific manifestations of shame (eg, embarrassment, fear of judgment, and self-blame), concealment behaviors (eg, silence, avoidance, and impression management), provider communication behaviors (eg, time pressure, use of jargon, dismissiveness, and validation), and key findings. The accuracy of the data will be verified by multiple reviewers. Data will be synthesized using thematic synthesis, with the findings presented in tables; narrative synthesis; and a conceptual model depicting the interactions among shame, concealment, and provider communication. The findings will describe how shame and concealment are conceptualized, how they shape communication and care, and strategies suggested to reduce their effects. A conceptual diagram will illustrate these dynamics.</p><p><strong>Results: </strong>This study was funded in April 2025. Database searching is scheduled for October 2025, with study selection and data extraction planned for November 2025. As of September 2025, no data extraction has been completed. Data synthesis is expected to be finalized by December 2025, and results are planned for publ
背景:健康素养,定义为获取、理解、评价和使用健康信息的能力,影响健康行为和结果。低健康素养(LHL)与对治疗指示的误解、依从性差和预防行为不充分有关,所有这些都导致了健康差异。虽然普遍的预防措施,如通俗易懂的语言和反导方法被推荐,但最近的研究表明,这些措施本身并不能完全解决LHL患者面临的挑战。以前的定性研究考察了羞耻和隐瞒塑造医患沟通的心理社会过程;然而,这些发现在不同的环境和学科中仍然是碎片化的,而且还没有范围界定或系统评价来综合这些证据。目的:本综述旨在了解LHL患者经历羞耻和隐瞒的过程,卫生保健提供者的行为和沟通如何影响这些经历,以及这些过程如何影响医患沟通和护理。它还寻求确定策略,以减少羞耻感和隐瞒在临床实践中的影响。方法:本综述将按照PRISMA-ScR(系统评价和荟萃分析扩展范围评价的首选报告项目)指南进行和报告。PubMed、MEDLINE、CINAHL、PsycInfo、Web of Science和Academic Search Complete将使用与健康素养、医患沟通和定性研究相关的术语进行搜索。有定性结果的定性和混合方法研究将被纳入,仅定量研究将被排除。参与者可能包括患者、卫生保健提供者,或两者都包括。数据提取将包括羞耻的具体表现(例如,尴尬,害怕判断和自责),隐藏行为(例如,沉默,回避和印象管理),提供者沟通行为(例如,时间压力,使用术语,轻蔑和验证),以及关键发现。数据的准确性将由多个审稿人验证。数据将采用专题综合的方法加以综合,结果列于表内;叙述合成;以及描述羞耻、隐瞒和提供者沟通之间相互作用的概念模型。研究结果将描述羞耻和隐瞒是如何被概念化的,它们是如何影响沟通和关怀的,以及建议减少它们影响的策略。一个概念图将说明这些动态。结果:本研究于2025年4月获得资助。数据库检索计划于2025年10月进行,研究选择和数据提取计划于2025年11月进行。截至2025年9月,尚未完成数据提取。数据综合预计将于2025年12月完成,结果计划于2026年6月至8月公布。结论:这将是第一个系统地描绘羞耻和隐瞒在LHL患者卫生保健沟通中的作用的范围综述。综合定性证据将提供对关系动态的见解,为专业教育和培训提供信息,并指导组织和政策层面的战略,以促进公平和以患者为中心的卫生保健沟通。
{"title":"Role of Shame and Concealment in Patient-Provider Communication Among Individuals With Low Health Literacy: Protocol for a Scoping Review.","authors":"Tsuyoshi Okuhara, Hiroko Okada, Rie Yokota","doi":"10.2196/83451","DOIUrl":"10.2196/83451","url":null,"abstract":"<p><strong>Background: </strong>Health literacy, defined as the ability to obtain, understand, evaluate, and use health information, influences health behaviors and outcomes. Low health literacy (LHL) is associated with misunderstandings of treatment instructions, poor adherence, and inadequate preventive behaviors, all of which contribute to health disparities. Although universal precautions such as plain language and the teach-back method are recommended, recent studies indicate that these measures alone cannot fully address the challenges faced by patients with LHL. Previous qualitative studies have examined psychosocial processes through which shame and concealment shape patient-provider communication; however, these findings remain fragmented across settings and disciplines, and no scoping or systematic review has yet synthesized this evidence.</p><p><strong>Objective: </strong>This review aims to map how patients with LHL experience shame and concealment, how health care providers' behaviors and communication influence these experiences, and how these processes affect patient-provider communication and care. It also seeks to identify strategies to reduce the impact of shame and concealment in clinical practice.</p><p><strong>Methods: </strong>This review will be conducted and reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. PubMed, MEDLINE, CINAHL, PsycInfo, Web of Science, and Academic Search Complete will be searched using terms related to health literacy, patient-provider communication, and qualitative research. Qualitative and mixed methods studies with qualitative findings will be included, and quantitative-only studies will be excluded. The participants may include patients, health care providers, or both. Data extraction will include specific manifestations of shame (eg, embarrassment, fear of judgment, and self-blame), concealment behaviors (eg, silence, avoidance, and impression management), provider communication behaviors (eg, time pressure, use of jargon, dismissiveness, and validation), and key findings. The accuracy of the data will be verified by multiple reviewers. Data will be synthesized using thematic synthesis, with the findings presented in tables; narrative synthesis; and a conceptual model depicting the interactions among shame, concealment, and provider communication. The findings will describe how shame and concealment are conceptualized, how they shape communication and care, and strategies suggested to reduce their effects. A conceptual diagram will illustrate these dynamics.</p><p><strong>Results: </strong>This study was funded in April 2025. Database searching is scheduled for October 2025, with study selection and data extraction planned for November 2025. As of September 2025, no data extraction has been completed. Data synthesis is expected to be finalized by December 2025, and results are planned for publ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e83451"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12858102/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093145","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}
Sarah Nauman Ghazi, Anders Behrens, Joakim Niklasson, Johan Sanmartin Berglund, Peter Anderberg
Background: Evening technology use (ETU) has been associated with sleep disturbances, often attributed to blue light exposure and cognitive arousal. However, most of the existing evidence focuses on younger populations and relies primarily on subjective measures. As older adults increasingly engage with both passive and active technology use, it is important to investigate how ETU impacts objective sleep. Currently, there is also a limited understanding of how particular evening digital activities, especially active versus passive engagement, affect objective sleep in older adults.
Objective: This study aims to investigate the impact of exposure to ETU on both objective and subjective sleep outcomes in older adults.
Methods: This is a randomized crossover trial involving approximately 55 adults aged 60-75 years from the ongoing Swedish National Study on Aging and Care - Blekinge. Each participant will undergo 3 one-week intervention periods: active ETU, passive ETU, and a nondigital activity (book reading), with one-week washout periods in between. The order of interventions will be randomized. Sleep will be assessed using a home-based electroencephalography device (MUSE headband) and daily self-reports. Primary outcomes are sleep onset latency and wake after sleep onset. Secondary outcomes include objective measures such as total sleep time, sleep efficiency, and time spent in REM, deep, and light sleep, subjective sleep quality, adherence, and perception of the intervention and comfort of using the objective measurement tool, that is, the electroencephalography headband. Linear mixed-effects models (with fixed effects for condition and period and a random participant intercept) were used to analyze crossover effects on sleep outcomes.
Results: Participant recruitment and data collection began in the fall of 2025 and will continue through summer 2026 or until the target sample size is reached. Data collection is scheduled to be completed by spring 2027. Results will include participant flow, baseline characteristics, adherence data, and comparative analyses of the 3 intervention conditions. Within-subject statistical models will be used to evaluate differences in sleep outcomes and investigate the associations between ETU and sleep quality.
Conclusions: This crossover study will clarify how active and passive ETU, compared with a nondigital activity, relate to objective sleep in older adults. Findings will inform simple, practical recommendations for technology use before bed in late life.
{"title":"The Effect of Evening Technology Use on Objective Sleep in Older Adults: Protocol for a Crossover Randomized Controlled Trial.","authors":"Sarah Nauman Ghazi, Anders Behrens, Joakim Niklasson, Johan Sanmartin Berglund, Peter Anderberg","doi":"10.2196/84512","DOIUrl":"10.2196/84512","url":null,"abstract":"<p><strong>Background: </strong>Evening technology use (ETU) has been associated with sleep disturbances, often attributed to blue light exposure and cognitive arousal. However, most of the existing evidence focuses on younger populations and relies primarily on subjective measures. As older adults increasingly engage with both passive and active technology use, it is important to investigate how ETU impacts objective sleep. Currently, there is also a limited understanding of how particular evening digital activities, especially active versus passive engagement, affect objective sleep in older adults.</p><p><strong>Objective: </strong>This study aims to investigate the impact of exposure to ETU on both objective and subjective sleep outcomes in older adults.</p><p><strong>Methods: </strong>This is a randomized crossover trial involving approximately 55 adults aged 60-75 years from the ongoing Swedish National Study on Aging and Care - Blekinge. Each participant will undergo 3 one-week intervention periods: active ETU, passive ETU, and a nondigital activity (book reading), with one-week washout periods in between. The order of interventions will be randomized. Sleep will be assessed using a home-based electroencephalography device (MUSE headband) and daily self-reports. Primary outcomes are sleep onset latency and wake after sleep onset. Secondary outcomes include objective measures such as total sleep time, sleep efficiency, and time spent in REM, deep, and light sleep, subjective sleep quality, adherence, and perception of the intervention and comfort of using the objective measurement tool, that is, the electroencephalography headband. Linear mixed-effects models (with fixed effects for condition and period and a random participant intercept) were used to analyze crossover effects on sleep outcomes.</p><p><strong>Results: </strong>Participant recruitment and data collection began in the fall of 2025 and will continue through summer 2026 or until the target sample size is reached. Data collection is scheduled to be completed by spring 2027. Results will include participant flow, baseline characteristics, adherence data, and comparative analyses of the 3 intervention conditions. Within-subject statistical models will be used to evaluate differences in sleep outcomes and investigate the associations between ETU and sleep quality.</p><p><strong>Conclusions: </strong>This crossover study will clarify how active and passive ETU, compared with a nondigital activity, relate to objective sleep in older adults. Findings will inform simple, practical recommendations for technology use before bed in late life.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e84512"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12857899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093180","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}
Kavisha Shah, Anna Janssen, Cameron Stewart, Tim Shaw, Ian Kerridge
Background: The growing digitization of health data has expanded opportunities for professional learning and performance improvement. While they provide new means for improving the quality and safety of health care, these new capabilities for data analysis and performance monitoring come with risks and may exacerbate existing ethico-legal concerns about fairness, accountability, privacy, and more.
Objective: This study aims to develop an ethico-legal framework for the evaluation of professional performance that is cognizant of these concerns and addresses the needs of relevant stakeholders. The study will assess the acceptability, comprehensiveness, and potential utility of the framework from the perspective of end users and subject matter experts.
Methods: This study will use existing evidence on ethico-legal considerations surrounding secondary uses of health data for performance improvement and management to draft the framework. We will conduct 2 focus groups with end users (eg, health professionals and administrators) and subject matter experts (eg, clinical ethicists and legal practitioners). These focus groups will ask participants to reflect on the framework's structure and comprehension, intended audience, comprehensiveness and relevance regarding ethical and legal principles, limitations, and utility and acceptability as a step-by-step guide. Study participants may also opt for one-on-one interviews for any reason. This feedback will be thematically analyzed using open coding and verified by an independent reviewer at the focus groups, followed by constant comparisons of feedback from this study to concepts and interrelationships in data previously collected.
Results: Recruitment for this study is scheduled from August to December 2025. The analysis, compilation, and dissemination of higher-order themes, concepts, and outcomes is planned for after publication of this protocol, after each interview or focus group has been transcribed and coded line by line.
Conclusions: This study seeks to create an actionable tool that is readily translatable to clinical practice in collaboration with end users and subject matter experts. The proposed methodology is a low-resource coapproach that could be iteratively refined to ensure that the proposed framework continues to support robust and efficient use of performance data while respecting the different contexts in which practice analytics may be delivered. This systematic approach to principle-led evaluation of performance and conduct could inform technology-neutral governance capable of addressing perennial concerns about fairness, privacy, and transparency when using health data for professional learning and performance management.
{"title":"Development of an Ethico-Legal Framework for Quality Improvement and Performance Management in Health Care: Protocol for a Qualitative Study.","authors":"Kavisha Shah, Anna Janssen, Cameron Stewart, Tim Shaw, Ian Kerridge","doi":"10.2196/82167","DOIUrl":"10.2196/82167","url":null,"abstract":"<p><strong>Background: </strong>The growing digitization of health data has expanded opportunities for professional learning and performance improvement. While they provide new means for improving the quality and safety of health care, these new capabilities for data analysis and performance monitoring come with risks and may exacerbate existing ethico-legal concerns about fairness, accountability, privacy, and more.</p><p><strong>Objective: </strong>This study aims to develop an ethico-legal framework for the evaluation of professional performance that is cognizant of these concerns and addresses the needs of relevant stakeholders. The study will assess the acceptability, comprehensiveness, and potential utility of the framework from the perspective of end users and subject matter experts.</p><p><strong>Methods: </strong>This study will use existing evidence on ethico-legal considerations surrounding secondary uses of health data for performance improvement and management to draft the framework. We will conduct 2 focus groups with end users (eg, health professionals and administrators) and subject matter experts (eg, clinical ethicists and legal practitioners). These focus groups will ask participants to reflect on the framework's structure and comprehension, intended audience, comprehensiveness and relevance regarding ethical and legal principles, limitations, and utility and acceptability as a step-by-step guide. Study participants may also opt for one-on-one interviews for any reason. This feedback will be thematically analyzed using open coding and verified by an independent reviewer at the focus groups, followed by constant comparisons of feedback from this study to concepts and interrelationships in data previously collected.</p><p><strong>Results: </strong>Recruitment for this study is scheduled from August to December 2025. The analysis, compilation, and dissemination of higher-order themes, concepts, and outcomes is planned for after publication of this protocol, after each interview or focus group has been transcribed and coded line by line.</p><p><strong>Conclusions: </strong>This study seeks to create an actionable tool that is readily translatable to clinical practice in collaboration with end users and subject matter experts. The proposed methodology is a low-resource coapproach that could be iteratively refined to ensure that the proposed framework continues to support robust and efficient use of performance data while respecting the different contexts in which practice analytics may be delivered. This systematic approach to principle-led evaluation of performance and conduct could inform technology-neutral governance capable of addressing perennial concerns about fairness, privacy, and transparency when using health data for professional learning and performance management.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82167"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12857889/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093148","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}
Qingnan Fu, Kaihui Xiao, Jie Zhang, Yang Li, Yuxian Wang, Molin Jiang, Zengqi Man, Jing Yang, Wei Lu
Background: Selective serotonin reuptake inhibitors are first-line antidepressants; however, only approximately 60% of patients can benefit from them. There is insufficient evidence for using acupuncture for symptom relief or for improving tolerance to selective serotonin reuptake inhibitors.
Objective: This randomized controlled trial aims to assess the effects of acupuncture combined with citalopram hydrobromide on mild to moderate depression in older people.
Methods: This study is a 2-arm, parallel, randomized controlled trial. A total of 132 participants aged 60 to 80 years diagnosed with major depressive disorder were divided into an acupuncture and medication group or a medication group. Participants in both groups take citalopram hydrobromide at a dose of up to 20 mg daily for 12 weeks. The acupuncture and medication group additionally receives 36 sessions of acupuncture treatment over 12 weeks. The primary outcome is the response rate of the 17-item Hamilton Depression Scale at the twelfth week. The secondary outcomes include changes in scores on the 17-item Hamilton Depression Scale and Mini-Mental State Examination at various time points. Adverse events will be recorded in detail.
Results: The study commenced on June 30, 2023, and as of October 17, 2024, a total of 132 participants had been enrolled. Data collection has been completed. Currently, data analysis is in progress, with preliminary findings anticipated to be available by October 2025. The findings of this study are expected to be submitted for publication in 2026.
Conclusions: This pilot study is expected to provide critical insights into the feasibility of integrating acupuncture with standard medication for managing mild to moderate depression in older people. By generating preliminary evidence on its potential benefits, the study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for depression.
{"title":"Efficacy of Acupuncture for Mild to Moderate Depression in Older People: Protocol for a Randomized Controlled Trial.","authors":"Qingnan Fu, Kaihui Xiao, Jie Zhang, Yang Li, Yuxian Wang, Molin Jiang, Zengqi Man, Jing Yang, Wei Lu","doi":"10.2196/79327","DOIUrl":"10.2196/79327","url":null,"abstract":"<p><strong>Background: </strong>Selective serotonin reuptake inhibitors are first-line antidepressants; however, only approximately 60% of patients can benefit from them. There is insufficient evidence for using acupuncture for symptom relief or for improving tolerance to selective serotonin reuptake inhibitors.</p><p><strong>Objective: </strong>This randomized controlled trial aims to assess the effects of acupuncture combined with citalopram hydrobromide on mild to moderate depression in older people.</p><p><strong>Methods: </strong>This study is a 2-arm, parallel, randomized controlled trial. A total of 132 participants aged 60 to 80 years diagnosed with major depressive disorder were divided into an acupuncture and medication group or a medication group. Participants in both groups take citalopram hydrobromide at a dose of up to 20 mg daily for 12 weeks. The acupuncture and medication group additionally receives 36 sessions of acupuncture treatment over 12 weeks. The primary outcome is the response rate of the 17-item Hamilton Depression Scale at the twelfth week. The secondary outcomes include changes in scores on the 17-item Hamilton Depression Scale and Mini-Mental State Examination at various time points. Adverse events will be recorded in detail.</p><p><strong>Results: </strong>The study commenced on June 30, 2023, and as of October 17, 2024, a total of 132 participants had been enrolled. Data collection has been completed. Currently, data analysis is in progress, with preliminary findings anticipated to be available by October 2025. The findings of this study are expected to be submitted for publication in 2026.</p><p><strong>Conclusions: </strong>This pilot study is expected to provide critical insights into the feasibility of integrating acupuncture with standard medication for managing mild to moderate depression in older people. By generating preliminary evidence on its potential benefits, the study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for depression.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e79327"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12857896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093190","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}
Robert Rosales, Suzanne M Colby, Kristina M Jackson, Christina S Lee, Jacob John van den Berg, Madelyn Clancy, Ethan H Mereish, Robert Miranda
Background: Sexual minority youth (SMY) are significantly more likely to use alcohol compared with their heterosexual peers. Recent national data also suggest a turning point in alcohol use disparities: Latinx youth now report higher alcohol use than non-Latinx youth. Despite this, little is known about the social context and reasons why Latinx SMY may engage in alcohol use.
Objective: This manuscript describes the protocol for a study designed to assess real-time exposure to minority stressors and protective factors, and their relationship to alcohol use among Latinx and non-Latinx White SMY.
Methods: The project is being conducted in 3 phases with a combined sample of approximately 140 participants. Phase 1 (completed) involved cognitive interviews with 23 SMY participants, which refined and adapted survey measures to ensure cultural and developmental appropriateness for the next study phases. Phase 2 was a pilot ecological momentary assessment (EMA) survey with 20 participants to evaluate feasibility, acceptability, and compliance (completed). Phase 3 will recruit approximately 100 SMY aged 15-19 years, with equal representation of Latinx and non-Latinx White SMY. Participants will complete a baseline survey and repeated EMA surveys to capture daily experiences of stressors, protective factors, and alcohol use.
Results: Results for the study sample, recruitment (between April 2022 and November 2023), and challenges confronted are presented for Phase 1. Findings showed that the study sample included 23 Latinx and non-Latinx SMY, split almost in half by ethnicity. Participants were mostly female and affluent. Recruitment efforts showed that certain flyers and locations (eg, Facebook/Instagram) performed better at recruiting this sample. We present issues faced with screening out ineligible participants and bots, recruiting participants assigned male at birth, recruiting 15- to 17-year-old participants, and building overall trust with this population. Results from the rest of the data in this study will be analyzed and disseminated through peer-reviewed scientific journals.
Conclusions: This study will provide novel data on the real-time contexts of alcohol use among SMY with particular attention to Latinx youth, an understudied and marginalized population. By identifying stress and protective mechanisms linked to alcohol use, findings can inform tailored prevention and intervention strategies. Furthermore, the protocol offers a replicable framework for future EMA research on intersectionality, minority stress, and alcohol use among diverse SMY populations.
International registered report identifier (irrid): DERR1-10.2196/87201.
{"title":"Real-Time Exposure to Intersectional Minority Stressors and Alcohol Use: Protocol for an Ecological Momentary Assessment Study With Latinx and Non-Latinx Sexual Minority Youth.","authors":"Robert Rosales, Suzanne M Colby, Kristina M Jackson, Christina S Lee, Jacob John van den Berg, Madelyn Clancy, Ethan H Mereish, Robert Miranda","doi":"10.2196/87201","DOIUrl":"10.2196/87201","url":null,"abstract":"<p><strong>Background: </strong>Sexual minority youth (SMY) are significantly more likely to use alcohol compared with their heterosexual peers. Recent national data also suggest a turning point in alcohol use disparities: Latinx youth now report higher alcohol use than non-Latinx youth. Despite this, little is known about the social context and reasons why Latinx SMY may engage in alcohol use.</p><p><strong>Objective: </strong>This manuscript describes the protocol for a study designed to assess real-time exposure to minority stressors and protective factors, and their relationship to alcohol use among Latinx and non-Latinx White SMY.</p><p><strong>Methods: </strong>The project is being conducted in 3 phases with a combined sample of approximately 140 participants. Phase 1 (completed) involved cognitive interviews with 23 SMY participants, which refined and adapted survey measures to ensure cultural and developmental appropriateness for the next study phases. Phase 2 was a pilot ecological momentary assessment (EMA) survey with 20 participants to evaluate feasibility, acceptability, and compliance (completed). Phase 3 will recruit approximately 100 SMY aged 15-19 years, with equal representation of Latinx and non-Latinx White SMY. Participants will complete a baseline survey and repeated EMA surveys to capture daily experiences of stressors, protective factors, and alcohol use.</p><p><strong>Results: </strong>Results for the study sample, recruitment (between April 2022 and November 2023), and challenges confronted are presented for Phase 1. Findings showed that the study sample included 23 Latinx and non-Latinx SMY, split almost in half by ethnicity. Participants were mostly female and affluent. Recruitment efforts showed that certain flyers and locations (eg, Facebook/Instagram) performed better at recruiting this sample. We present issues faced with screening out ineligible participants and bots, recruiting participants assigned male at birth, recruiting 15- to 17-year-old participants, and building overall trust with this population. Results from the rest of the data in this study will be analyzed and disseminated through peer-reviewed scientific journals.</p><p><strong>Conclusions: </strong>This study will provide novel data on the real-time contexts of alcohol use among SMY with particular attention to Latinx youth, an understudied and marginalized population. By identifying stress and protective mechanisms linked to alcohol use, findings can inform tailored prevention and intervention strategies. Furthermore<strong>,</strong> the protocol offers a replicable framework for future EMA research on intersectionality, minority stress, and alcohol use among diverse SMY populations.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/87201.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e87201"},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146085864","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}