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Coronary Artery DiseaseNCT06162793

eHealth for Promoting Physical Activity

A study testing RehaPlus+ in people with Coronary Artery Disease, run by University of Witten/Herdecke at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
RehaPlus+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteGermany
Study dates
1 Sep 2021to 14 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • language barriers
  • incapable of understanding study information

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Clinic Königsfeld

    Ennepetal, North Rhine-Westphalia, 58256

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
RehaPlus+
Keywords
rehabilitation, eHealth, mHealth, telemedicine, cardiovascular disease
Medical subject headings
Coronary Artery Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehaPlus+Behavioural

    24-week eHealth intervention

Study groups in NCT06162793
Study groupRoleWhat they receive
RehaPlus+ExperimentalCustomized motivational text messages twice weekly for six months
Receives: Behavioral: RehaPlus+
Usual careNo interventionStandard care (Six-month German outpatient program "IRENA")

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week 24

  2. 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.

    Measured: week 24

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and week 24

  2. 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.

    Measured: Baseline and week 24

  3. 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.

    Measured: Baseline and week 24

  4. 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.

    Measured: Baseline and week 24

  5. 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.

    Measured: week 24

  6. 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.

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start1 Sep 2021
  3. Primary completion14 Nov 2023
  4. Study completion14 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Quasi-experimental design
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162793
Sponsor's protocol ID
eHealth_RehaPlus_01
Status last verified
Nov 2023
First submitted
20 Nov 2023
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37154363

  • 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.

    PubMed 39378432

Questions about this trial

What is this clinical trial studying?

A study testing RehaPlus+ in people with Coronary Artery Disease, run by University of Witten/Herdecke at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity (time frame: week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06162793, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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eHealth for Promoting Physical Activity (NCT06162793) | AzTrials