Background: The impact of adverse childhood experiences (ACEs) has been the focus of most studies for the past decade. There is an indication that developing resilience can help youth overcome these ACEs.
Objective: This article presents a study protocol for a randomized controlled trial (RCT) to investigate the effects of a resilience-building intervention on psychological well-being, coping strategies, stress, quality of life, resilience, resource finding, and resilience among individuals affected with ACEs in Malaysia.
Methods: The is a 2-armed, single-blind, RCT, whereby 50 participants (25 in each group) with ACEs will be randomly assigned to intervention and control groups. The former will be exposed to a resilience-building program (R2), which entails a multisystemic approach to resilience and recognizes the importance of rugged qualities and access to resources among individuals affected with ACEs. The intervention will be delivered via internet-based by a facilitator and broadly divided into 5 sessions, focusing on self-exploration and social support, coping techniques and coping skills, resource finding, spirituality, and resilience building. Meanwhile, the control group participants will not receive any form of intervention. Saliva samples will also be collected from both groups and assessed for salivary cortisol levels. Outcome measures will be assessed during baseline and postintervention using validated instruments. Another follow-up measurement will be conducted 4 weeks later.
Results: The clinical trial has been registered with the Australia New Zealand Clinical Trials Registry. Ethical approval was obtained from the Research Ethics Board at the National University of Malaysia (UKM PPI/111/8/JEP-2021-894). A total of 28 participants have been recruited to the RCT Participant recruitment will be completed by January 2025. The final analysis will be conducted by March 2025.
Conclusions: This is among the first studies to provide evidence in the context of RCTs for resilience-building intervention that combines self-report and physiological measures (ie, saliva and heart blood pressure) among individuals with ACEs. The findings will assist relevant authorities in the health and policy sectors to develop effective strategies for addressing the negative impacts of ACEs on the vulnerable population in Malaysia.
Trial registration: ACTRN12622000604707; https://www.anzctr.org.au/Trial/Result/DataSharingStatement.aspx?id=383614.
International registered report identifier (irrid): DERR1-10.2196/56826.
Background: Combining effective eHealth programs with face-to-face consultations in general practice may help general practitioners care for survivors of cancer.
Objective: This study protocol describes a 2-armed randomized controlled trial to evaluate the cost-effectiveness of a blended intervention integrating the Cancer Aftercare Guide in general practice centers (GPCs).
Methods: A parallel-group design will compare an intervention group with a waiting list control group. Participants will be nested within GPCs and randomization will occur at the GPC level. The participants in the intervention group will receive a blended care intervention. In contrast, the participants in the waiting list control group will receive care as usual for the duration of this study and will receive the online intervention afterward. All participants will be asked to complete an online questionnaire at baseline, 6 months, and 12 months after baseline, measuring self-reported adherence to lifestyle recommendations, psychosocial well-being, and quality of life. A process evaluation and cost evaluation are also included in this study. The effects will be evaluated based on differences in residual change scores between intervention and control group participants, using multilevel linear regression analyses. Moreover, effect analyses will be supplemented with Bayes factor analyses. Finally, an economic evaluation will be conducted from a societal perspective and will include medical costs, productivity costs, and costs of the blended care intervention.
Results: This study was funded in July 2020. Data collection started in August 2022 and is likely to be completed by April 2025. As of December 2024, a total of 127 participants have been included in this study, recruited across 26 GPCs in the Netherlands. Data analysis will commence once data collection is completed. Data analysis is estimated to start in the spring of 2025. The results will likely be published in 2026.
Conclusions: The results will provide insight into the effectiveness of blended care and may be relevant to cancer aftercare, general practice, and the field of eHealth implementation in general. Potential challenges lie in recruitment due to the strain on the health care system since the COVID-19 pandemic.
Trial registration: ISRCTN ISRCTN12451453; https://www.isrctn.com/ISRCTN12451453.
International registered report identifier (irrid): DERR1-10.2196/64662.
Background: The goal of just-in-time adaptive interventions (JITAIs) is to use mobile, digital tools to provide individuals with personalized interventions at the optimal time and in the optimal context. Accordingly, JITAIs are promising for advancing accessible, equitable, and evidence-based treatment for behavioral health. To guide future inquiry in this space, a review of the literature is needed to describe the state of research on JITAIs for behavioral health.
Objective: This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention development. In addition, conditional upon a sufficiently homogeneous literature, we will conduct meta-analyses to investigate the effectiveness of JITAIs for promoting distal outcomes (here, aspects of behavioral health) and proximal outcomes (eg, emotion regulation).
Methods: This systematic review is being conducted in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols). We developed our search strategy and executed the literature search in collaboration with biomedical librarians; 5 databases (PubMed, Embase, Cochrane Library, Web of Science: Core Collection, and APA PsycINFO) were searched, and results were managed using EndNote 20 (Clarivate). We are screening (title, abstract, and full text) all records in duplicate in Covidence according to eligibility criteria. Data items will be extracted, and risk of bias will be assessed in duplicate from the included articles in Covidence. We will summarize JITAI characteristics in tables and text. We will conduct meta-analyses for the distal and proximal outcomes conditional upon sufficient homogeneity in subgroups. Moderation (conditional upon sufficient heterogeneity of outcomes) and mediation (ie, whether changes in proximal outcomes mediate the relation between JITAIs and distal outcomes) will be conducted as appropriate. We will investigate publication bias and use the Grading of Recommendations Assessment, Development and Evaluation to characterize the quality of evidence of our estimates.
Results: The search strategy was developed between July 2023 and November 2023. The literature search was executed between November 2023 and December 2023. Title and abstract screening began in December 2023, and full-text screening began in May 2024. Data extraction and analyses have not begun.
Conclusions: Here, we propose a systematic review to assess the state of the literature on JITAIs for behavioral health. The insights derived from this study will describe the literature on JITAIs in promoting behavioral health, reinforce JITAI definitions, clarify JITAI elements, and inform the next steps in JITAI research.
International registered report identifier (irrid): PRR1-10.2196/58917.
Background: Postoperative rehabilitation following total knee arthroplasty (TKA) varies worldwide. In Finland, patients receive guidance on safe walking and home exercises from a physiotherapist both before and after TKA. These are performed independently after surgery. However, a sedentary lifestyle is rather common among patients who have undergone TKA, with pain often limiting postoperative walking, training, and activities of daily living.
Objective: This randomized controlled trial aimed to investigate the effectiveness of anti-gravity exercise, precisely the AlterG anti-gravity treadmill, on postoperative rehabilitation following TKA and to obtain new knowledge on this form of rehabilitation to better use it in the future.
Methods: This randomized controlled trial study divided the patients into two groups: the intervention group and the control group. The follow-up period was 12 months. Research data were collected through questionnaires and functional tests. All patients in both groups responded to the questionnaires and participated in functional tests before surgery as well as 4 and 12 months after surgery. Patients in the intervention group exercised on the AlterG treadmill 10 times after the surgery. All the patients in this study performed the exercises as instructed when they were in the hospital. The primary outcomes were perceived pain, walking ability, and quality of life.
Results: The data collection process began in 2018 and concluded in 2022, intending to obtain valuable information regarding the effect of AlterG training after TKA and determine whether it, along with traditional exercises, could be an effective form of rehabilitation that can be performed at home. We hypothesized that AlterG training would lead to faster rehabilitation, better walking quality, improved quality of life, improved physical activity, and improved overall functioning. The results of this study will be analyzed in 2025 and 2026.
Conclusions: This study provides information on how AlterG training can be used in rehabilitation after TKA, further enhancing the rehabilitation program for patients undergoing TKA in general.
Trial registration: ClinicalTrials.gov NCT03904030; https://clinicaltrials.gov/study/NCT03904030.
International registered report identifier (irrid): DERR1-10.2196/59935.
Background: Electronic health records (EHRs) have been associated with information overload, causing providers to miss critical information, make errors, and delay care. Information overload can be especially prevalent in medical intensive care units (ICUs) where patients are often critically ill and their charts contain large amounts of data points such as vitals, test and laboratory results, medications, and notes.
Objective: We propose to study the relationship between information overload and EHR use among medical ICU providers in 4 major United States medical centers. In this study, we examined 2 prominent EHR systems in the United States to generate reproducible and generalizable findings.
Methods: Our study collected physiological and objective data through the use of a screen-mounted eye-tracker. We aim to characterize information overload in the EHR by examining ICU providers' decision-making and EHR usability. We also surveyed providers on their institution's EHR to better understand how they rate the system's task load and usability using the NASA (National Aeronautics and Space Administration) Task Load Index and Computer System Usability Questionnaire. Primary outcomes include the number of eye fixations during each case, the number of correct decisions, the time to complete each case, and number of screens visited. Secondary outcomes include case complexity performance, frequency of mouse clicks, and EHR task load and usability using provided surveys.
Results: This EHR usability study was funded in 2021. The study was initiated in 2022 with a completion date of 2025. Data collection for this study was completed in December 2023 and data analysis is ongoing with a total of 81 provider sessions recorded.
Conclusions: Our study aims to characterize information overload in the EHR among medical ICU providers. By conducting a multisite, cross-sectional usability assessment of information overload in 2 leading EHRs, we hope to reveal mechanisms that explain information overload. The insights gained from this study may lead to potential improvements in EHR usability and interface design, which could improve health care delivery and patient safety.
International registered report identifier (irrid): DERR1-10.2196/66127.
Background: Noncommunicable diseases (NCDs) require a longer period of care, for which health care systems must acquire technologically advanced solutions to enhance patient care. Swasthya Pahal (health for all) is an innovative, interactive, multilingual, stand-alone, internet-enabled computer-based program that aims to improve the self-management of NCDs.
Objective: This study aims to enhance the self-management of chronic NCDs (diabetes, hypertension, high cholesterol, and obesity) by determining the usefulness, acceptance, and effectiveness of the Swasthya Pahal program in hospital and community settings in both rural and urban areas of Chennai, Tamil Nadu. This objective can be met by generating risk factor profiles of individuals enrolled and enhancing their self-management of NCDs using a portable health information kiosk that uses the Sustainable, Multisector, Accessible, Affordable, Reimbursable, and Tailored (SMAART) model.
Methods: A quantitative study will be conducted on a convenient sample of 2800 individuals from selected hospital and community settings in rural (n=1400) and urban areas (n=1400) in Chennai, Tamil Nadu. Data will be collected on sociodemographics, health behaviors, and clinical status, as well as knowledge, attitudes, and practices. Objective assessments such as weight, blood pressure, and random blood sugar levels will be measured. In addition, the usefulness, acceptance, and effectiveness of the Swasthya Pahal program will be determined.
Results: Results will be summarized using descriptive analysis. Appropriate bivariate and multivariate regression analysis will be performed to determine the predictors of the outcome variables of usefulness, acceptance, and effectiveness of Swasthya Pahal in wider settings. All analyses will be performed using SAS (version 9.1; SAS Institute), and the results will be reported as 95% CI values and P<.05.
Conclusions: The study proposes to enhance the self-management of NCDs in both rural and urban community settings through the implementation of the Swasthya Pahal program based on the SMAART informatics framework. The study aims to understand the implementation, acceptability, and usability of Swasthya Pahal among a diverse sample of people in urban and rural settings.
International registered report identifier (irrid): PRR1-10.2196/39950.
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