Coronary Artery Disease Clinical Trial
Official title:
eHealth for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance: the RehaPlus+ Concept
Verified date | November 2023 |
Source | University of Witten/Herdecke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Coronary artery disease (CAD) is a chronic disease without a definitive cure. Cardiac rehabilitation (CR) is a class IA recommendation for CAD patients, that focuses on risk factor reduction and physical exercise. It comprises three stages: Phase I in the acute setting, Phase II for reconditioning, and Phase III as maintenance. Despite the effectiveness of Phase II, there is often a decline in cardiovascular risk profiles afterward due to lifestyle challenges and inadequate support. Traditional maintenance programs face limitations, such as high costs and patient-related barriers. With the increasing prevalence of mobile devices and digitalization, eHealth can enhance rehabilitation effectiveness post-discharge. Previous studies support the effectiveness of eHealth in CR maintenance.This study aims to evaluate the effectiveness of the eHealth program "RehaPlus+" in motivating CAD patients for increased physical activity (PA).
Status | Completed |
Enrollment | 116 |
Est. completion date | November 14, 2023 |
Est. primary completion date | November 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - documented coronary artery disease - referral to inpatient rehabilitation - signed informed consent Exclusion Criteria: - language barriers - incapable of understanding study information |
Country | Name | City | State |
---|---|---|---|
Germany | Clinic Königsfeld | Ennepetal | NRW |
Lead Sponsor | Collaborator |
---|---|
University of Witten/Herdecke |
Germany,
Heimer M, Schmitz S, Teschler M, Schafer H, Douma ER, Habibovic M, Kop WJ, Meyer T, Mooren FC, Schmitz B. eHealth for maintenance cardiovascular rehabilitation: a systematic review and meta-analysis. Eur J Prev Cardiol. 2023 Oct 26;30(15):1634-1651. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity | Physical activity will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is unlimited. A higher value indicates a better outcome. | week 24 | |
Primary | Activity of Daily Living | Activity of Daily Living will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is unlimited. A higher value indicates a better outcome. | week 24 | |
Secondary | Change in Work requirements and workload | Work requirements and workload will be assessed using the "Workability Index (WAI)" questionnaire. The minimum value is 7, and the maximum value is 49, where a higher value indicates improved work ability. | Baseline and week 24 | |
Secondary | Change in Health-related quality of life | Health-related quality of life will be assessed using the SF-36 questionnaire. The minimum value is 0, and the maximum value is 100, where a higher value signifies greater well-being. | Baseline and week 24 | |
Secondary | Change in Wellbeing | Wellbeing will be assessed using the "WHO-5 Well-Being Index". The minimum value is 0, and the maximum value is 25, where a higher value signifies greater well-being. | Baseline and week 24 | |
Secondary | Change in Cardiac Self-Efficacy (CSE) | Cardiac self-efficacy will be measured using the Cardiac Self-Efficacy questionnaire. The minimum value is 0, and the maximum value is 100, where a higher value signifies greater well-being. | Baseline and week 24 | |
Secondary | Physical activity (PA) at work | Physical activity at work will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is 9. A higher value indicates a better outcome. | week 24 | |
Secondary | Climbed floors | Climbed floors will be assessed by the German "Physical Activity and Sports questionnaire" (BSA). The minimum value is 0, the maximum value is unlimited. A higher value indicates a better outcome. | week 24 |
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