JMIR Research Protocols最新文献

Background: Cardiometabolic diseases (CMDs) are a group of interrelated conditions, including heart failure and diabetes, that increase the risk of cardiovascular and metabolic complications. The rising number of Australians with CMDs has necessitated new strategies for those managing these conditions, such as digital health interventions. The effectiveness of digital health interventions in supporting people with CMDs is dependent on the extent to which users engage with the tools. Augmenting digital health interventions with conversational agents, technologies that interact with people using natural language, may enhance engagement because of their human-like attributes. To date, no systematic review has compiled evidence on how design features influence the engagement of conversational agent-enabled interventions supporting people with CMDs. This review seeks to address this gap, thereby guiding developers in creating more engaging and effective tools for CMD management.

Objective: The aim of this systematic review is to synthesize evidence pertaining to conversational agent-enabled intervention design features and their impacts on the engagement of people managing CMD.

Methods: The review is conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Searches will be conducted in the Ovid (Medline), Web of Science, and Scopus databases, which will be run again prior to manuscript submission. Inclusion criteria will consist of primary research studies reporting on conversational agent-enabled interventions, including measures of engagement, in adults with CMD. Data extraction will seek to capture the perspectives of people with CMD on the use of conversational agent-enabled interventions. Joanna Briggs Institute critical appraisal tools will be used to evaluate the overall quality of evidence collected.

Results: This review was initiated in May 2023 and was registered with the International Prospective Register of Systematic Reviews (PROSPERO) in June 2023, prior to title and abstract screening. Full-text screening of articles was completed in July 2023 and data extraction began August 2023. Final searches were conducted in April 2024 prior to finalizing the review and the manuscript was submitted for peer review in July 2024.

Conclusions: This review will synthesize diverse observations pertaining to conversational agent-enabled intervention design features and their impacts on engagement among people with CMDs. These observations can be used to guide the development of more engaging conversational agent-enabled interventions, thereby increasing the likelihood of regular intervention use and improved CMD health outcomes. Additionally, this review will identify gaps in the literature i

Background: Epilepsy requires continuous management and treatment to optimize patient outcomes. The advancement of digital health has led to the development of various mobile health (mHealth) tools designed to enhance treatment adherence among individuals with epilepsy. These solutions offer crucial support through features such as reminders, educational resources, personalized feedback, assistance with managing costs, shared decision-making, and access to supportive communities. To design effective medication adherence mHealth solutions, it is essential to evaluate the effectiveness of existing mHealth tools, understand the unique circumstances of different patients, and identify the roles of health care professionals within the digital care pathway. Existing studies on epilepsy primarily focus on self-management, whereas the effectiveness and usability of medical adherence mHealth solutions often remain overlooked. Furthermore, the involvement of health care professionals in digital care pathways for epilepsy as well as the impact of adherence mHealth solutions on the patient experience have not been adequately explored.

Objective: This study aims to assess the effectiveness of current mHealth solutions designed to improve medical adherence among patients with epilepsy. Furthermore, the study will examine the experiences of patients using mHealth solutions for maintaining medical adherence in epilepsy care. Finally, this review intends to determine the roles of health care professionals within mHealth systems aimed at supporting adherence to medication among patients with epilepsy.

Methods: A systematic literature review has been selected as the appropriate method to address the research questions, adhering to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The inclusion and exclusion criteria have been carefully selected, and both qualitative and quantitative analyses will be used to analyze the results. The expected results will mainly focus on the comparison, classification, and analysis of the effectiveness of current medical adherence mHealth tools. Moreover, the patient experiences using available medical adherence mHealth tools for epilepsy will be assessed. Finally, the role of health care professionals in the epilepsy digital care pathway will be explored, with emphasis on medical adherence.

Results: The initial search, full-text screening, and data extraction have been carried out. Thirty-three papers were included in the final stage of the review. The study is expected to be completed by October 2024.

Conclusions: To enhance the digital care pathway for epilepsy, a medical adherence mHealth solution should be personalized, manage medications, include an alarm system, track seizures, support consultations, and offer updated treatment plans. This study aims to understand how finding

Background: Chronic diseases are associated with a high disease burden. Under- and overprovision of care as well as quality variation between health care providers persists, while current quality indicators rarely capture the patients' perspective. Capturing patient-reported outcome measures (PROMs) as well as patient-reported experience measures (PREMs) is becoming more and more important to identify gaps in care provision, prioritize services most valuable to patients, and aid patients' self-management.

Objective: This study aims to measure the potential benefits and effectiveness of using electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures in a structured and population-based manner to enhance health care for chronic disease patients in Germany.

Methods: This prospective cohort study aims to evaluate the potential benefits of PROM usage in patients with chronic diseases. We evaluate whether (1) digitally collected PROMs and PREMs can be used for health system performance assessment by generating a representative response of chronically diseased individuals with asthma, chronic obstructive pulmonary disease, diabetes, and coronary artery disease across Germany, and (2) based on the PROMs and PREMs, low-value care can be identified. As patient-reported outcomes (PROs) are rarely presented back to patients, (3) this study also examines patients' reactions to their PROM scores in the form of digital PRO feedback. For these purposes, randomly selected patients from a nationwide German insurer are digitally surveyed with generic and disease-specific PROMs and PREMs, as well as additional questions on their health-related behavior, 4 times over 1 year. Individual PRO feedback is presented back to patients longitudinally and compared to a peer group after each survey period. Patient-reported data is linked with health insurance data. Response rates, changes in health and experience outcomes over time, self-reported changes in health behavior, and health care system usage will be analyzed.

Results: The PROMchronic study explores the usage of PROMs in patients with chronic diseases. Data collection began in October 2023, after the initial invitation letter. All the 200,000 potential patients have been invited to participate in the study. Data have not yet been analyzed. Publication of the interim results is planned for the autumn of 2024, and the results are planned to be published in 2025.

Conclusions: We aim to fill the research gap on the population-based usage of PROMs and PREMs in patients with chronic diseases and add to the current understanding of PROM data-sharing with patients. The study's results can thereby inform whether a health care system-wide approach to collecting PROMs and PREMs can be used to identify low-value care, assess quality variation within and across chronic con

Background: Older adults often face loneliness due to chronic illness or loss of close ones, a situation worsened by the COVID-19 pandemic. Increased loneliness heightens the risk of diseases, especially dementia, necessitating urgent action.

Objective: This study aims to assess the impact of a virtual reality (VR)-based open-air bath program on depression and loneliness in older individuals with subjective cognitive decline/mild cognitive impairment attending the Dementia Medical Center in Kyoto, Japan. We further aim to evaluate the feasibility of the program (participant recruitment and adherence) and to measure program enjoyment and satisfaction.

Methods: The study design is a crossover trial with a 1:1 ratio, wherein 12 participants will be randomly assigned to groups 1 and 2, with group 2 serving as a waitlist control and group 1 receiving the VR program from the onset for 6 months; the VR program will be conducted 6 times (monthly). Program completion for group 1 will be followed by an observation period from months 7 to 12. Group 2 will participate in the VR program from months 7 to 12, with an observation period from months 1 to 6. Cognitive tests, psychiatric assessments, and the University of California, Los Angeles Loneliness Scale will be conducted before the study, at 6 months, and at 12 months. Results will be analyzed using repeated-measures ANOVA. Head magnetic resonance imaging and single-photon emission computed tomography scans will be performed before and after the VR program to evaluate changes and effects on brain regions.

Results: Recruitment began in September 2023 and data collection is expected to be completed by March 2025. Complete study results will be published by September 2025.

Conclusions: This study examines the preliminary effects of VR on loneliness in older adults with predementia through open-air bath simulations. VR experiences could benefit this population, particularly those with limited outdoor activities. Quantifying VR's impact will aid in determining the size for a larger clinical trial. Qualitative results will inform participation mechanisms and guide the implementation and design of future trials.

Trial registration: University hospital Medical Information Network UMIN000052667; https://tinyurl.com/3yaccay5.

International registered report identifier (irrid): DERR1-10.2196/57101.

Background: Tobacco quitlines provide effective resources (eg, nicotine replacement therapy, smoking cessation counseling, and text and web-based support) for those who want to quit smoking in the United States. However, quitlines reach approximately only 1%-3% of people who smoke each year. Novel, smartphone-based, and low-burden interventions that offer 24/7 access to smoking cessation resources that are tailored to current readiness to quit may increase appeal, reach, and effectiveness of smoking cessation interventions.

Objective: This study will examine the efficacy of OKquit, a low-burden smartphone-based app for smoking cessation.

Methods: Approximately 500 people who smoke cigarettes and access the Oklahoma Tobacco Helpline (OTH) will be randomized to receive standard OTH care (SC) or SC plus the novel OKquit smartphone app for smoking cessation (OKquit). All participants will use a smartphone app to complete study surveys (ie, baseline, 27 weekly surveys, brief daily check-ins, and 27-week follow-up). Upon completion of daily check-ins and weekly surveys, participants will receive either trivia type messages (SC) or messages that are tailored to current readiness to quit smoking and currently experienced lapse triggers (OKquit). In addition, those assigned to receive the OKquit app will have access to on-demand smoking cessation content (eg, quit tips, smoking cessation medication tips). It is hypothesized that participants assigned to OKquit will be more likely to achieve biochemically verified 7-day point prevalence abstinence than those assigned to SC at 27 weeks post enrollment. In addition, participants who use more OTH resources (eg, more cessation coaching sessions completed) or more OKquit resources (eg, access more quit tips) will have greater biochemically verified smoking cessation rates.

Results: Data collection began in September 2022 and final follow-ups are expected to be completed by May 2025.

Conclusions: Data from this randomized controlled trial will determine whether the OKquit smartphone app combined with OTH care will increase smoking cessation rates over standard OTH care alone. If successful, OKquit could provide tailored intervention content at a fraction of the cost of traditional interventions. Furthermore, this type of low-burden intervention may offer a way to reach underserved populations of adults who smoke and want to quit.

Trial registration: ClinicalTrials.gov NCT05539209; https://clinicaltrials.gov/study/NCT05539209.

International registered report identifier (irrid): DERR1-10.2196/56827.

Background: Chronic spontaneous urticaria (CSU) is a common chronic inflammatory skin disease that manifests as itching and wheals, seriously affecting quality of life. Clinical observations and previous research trials have shown that acupuncture is safe and effective for the treatment of CSU. However, there are problems, such as a short duration of action and frequent treatment. Compared with traditional acupuncture, acupoint catgut embedding (ACE) has the advantages of a longer effect and higher compliance. Clinical trials are needed to prove its efficacy and mechanism of action.

Objective: This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE.

Methods: This is a randomized, double-blind, placebo-controlled trial. In this trial, 108 participants aged 18-60 years with a diagnosis of CSU and no history of ACE will be randomly assigned to 2 groups (1:1 ratio) using the Statistical Analysis System: treatment (ACE) and control (sham ACE). The participants and efficacy evaluators will be blinded to the grouping. Both the ACE and sham ACE groups will undergo acupuncture, but the sham ACE group will not receive catgut sutures. Treatment will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up period. Twenty patients will be randomly selected to undergo functional magnetic resonance imaging before and after the treatment period. The primary outcome will be the urticaria activity score over 7 days (UAS7). We will use R (version 4.0.1; R Project for Statistical Computing) to perform ANOVA and independent samples t tests to compare the differences within and between groups before and after treatment by judging the rejection range based on a significance level of .05.

Results: The study protocol has been approved by the Ethics Committee of Guang'anmen Hospital on September 7, 2022, and has been registered on November 30, 2022. Recruitment began on March 1, 2023. A total of 4-6 participants are expected to be recruited each month. The recruitment is planned to be completed on March 1, 2025, and we expect to publish our results by the winter of 2025. As of November 1, 2023, we have enrolled 25 participants with CSU.

Conclusions: This randomized, double-blind, placebo-controlled trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. We hypothesize that wheals and itching will show greater improvement in participants receiving active therapy than in those receiving sham treatment. The limitations of this study include its single-center trial design, small sample size, and short treatment duration, which may have certain impacts on the research results.

Trial registration: Chinese Clinical Trial Registry ChiCTR2200066274; https://www.chictr.org.cn/showprojEN.html?proj=179056.