eHealth for Promoting Physical Activity

NCT ID: NCT06162793

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-11-14

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.

Conditions

Coronary Artery Disease

Keywords

rehabilitation; eHealth; mHealth; telemedicine; cardiovascular disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

RehaPlus+

Customized motivational text messages twice weekly for six months

Group Type: EXPERIMENTAL

RehaPlus+

Intervention Type: BEHAVIORAL

24-week eHealth intervention

Usual care

Standard care (Six-month German outpatient program "IRENA")

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RehaPlus+

24-week eHealth intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• language barriers
• incapable of understanding study information

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinic Königsfeld

Ennepetal, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 37154363 (View on PubMed)

Waranski M, Garbsch R, Kotewitsch M, Teschler M, Schmitz B, Mooren FC. A Behavioral Change-Based Mobile Intervention for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance of Patients With Coronary Artery Disease: Controlled Trial. J Med Internet Res. 2024 Oct 8;26:e56480. doi: 10.2196/56480.

Reference Type: DERIVED

PMID: 39378432 (View on PubMed)

Other Identifiers

eHealth_RehaPlus_01

Identifier Type: -

Identifier Source: org_study_id