JMIR Research Protocols最新文献

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.

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.

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.

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.

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.

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.

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.