Clinical trial NCT06162793: eHealth for Promoting Physical Activity
Official title: eHealth for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance: the RehaPlus+ Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: rehabilitation
eHealth
mHealth
telemedicine
cardiovascular disease
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental design
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* documented coronary artery disease
* referral to inpatient rehabilitation
* signed informed consent

Exclusion Criteria:

* language barriers
* incapable of understanding study information

Primary outcomes:
measure: Physical Activity
timeFrame: week 24
measure: Activity of Daily Living
timeFrame: week 24
Secondary outcomes:
measure: Change in Work requirements and workload
timeFrame: Baseline and week 24
measure: Change in Health-related quality of life
timeFrame: Baseline and week 24
measure: Change in Wellbeing
timeFrame: Baseline and week 24
measure: Change in Cardiac Self-Efficacy (CSE)
timeFrame: Baseline and week 24
measure: Physical activity (PA) at work
timeFrame: week 24
measure: Climbed floors
timeFrame: week 24
Other outcomes:
Locations:
city: Ennepetal
country: Germany
facility: Clinic Königsfeld
state: NRW
Study officials:
References:
citation: 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: 10.1093/eurjpc/zwad145.