eHealth for Promoting Physical Activity

Study Overview
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Brief Summary
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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).

Detailed Description
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Coronary artery disease (CAD), a chronic disease lacking a definitive cure, can be mitigated through cardiac rehabilitation (CR). As a class IA recommendation for CAD patients, CR employs evidence-based therapy to minimize the physiological and psychological impacts of CAD, reduce morbidity and mortality rates, and enhance physical performance. CR involves three stages: Phase I for acute intervention, Phase II for reconditioning, and Phase III for maintenance. Despite the effectiveness of Phase II CR, cardiovascular risk profiles often deteriorate thereafter, attributed to the challenge of maintaining a healthy lifestyle and limited support of patients. Traditional maintenance programs face barriers such as high costs and time constraints while the COVID-19 pandemic further disrupted on-site programs.The rise of eHealth solutions, such as the RehaPlus+ concept, driven by innovative technologies and the prevalence of mobile devices, aligns with the trend of digitalization in healthcare. This evolution presents opportunities to enhance patient health maintenance, with eHealth applications amplifying rehabilitation effectiveness post-discharge. Previous studies support the efficacy of eHealth in CR maintenance. This study aims to assess the effectiveness of the eHealth program RehaPlus+ in supporting CAD patients for increased physical activity (PA). The hypothesis is that RehaPlus+ will be as effective as the German standard center-based program (IRENA) in supporting regular PA, Activity of Daily Living (AoDL), and improving psychological well-being, cardiac self-efficacy (CSE), health-related well-being, and work ability six months after Phase II CR discharge. The study will include patients with CAD allocated to either a 24-week eHealth group (RehaPlus+) or a conventional outpatient program group (IRENA) using a quasi-experimental approach. RehaPlus+ recipients will receive customized motivational text messages twice weekly for six months, while the IRENA group will engage in a six-month outpatient program involving 24 sessions of 90-minute strength and endurance training. The primary outcomes, evaluated using the BSA questionnaire, will focus on regular PA and weekly activities of daily living (AoDL) six months post-rehabilitation. Secondary outcomes will examine physical activity during work and floors climbed weekly (BSA), psychological well-being (WHO-5), cardiac self-efficacy (CSE), health-related well-being (SF-36), and work ability (WAI) via questionnaire.

Official Title
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eHealth for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance: the RehaPlus+ Concept

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: RehaPlus+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented coronary artery disease referral to inpatient rehabilitation signed informed consent Exclusion Criteria: language barriers incapable of understanding study information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RehaPlus+<br>Customized motivational text messages twice weekly for six months | Behavioral: RehaPlus+<br>* 24-week eHealth intervention<br>|
| No Intervention: Usual care<br>Standard care (Six-month German outpatient program IRENA) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, rehabilitation, eHealth, mHealth, telemedicine