NCT06162793

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

November 20, 2023

Last Update Submit

November 30, 2023

Conditions

Coronary Artery Disease

Keywords

rehabilitationeHealthmHealthtelemedicinecardiovascular disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Change in Work requirements and workload

    Baseline and week 24

  • Change in Health-related quality of life

    Baseline and week 24

  • Change in Wellbeing

    Baseline and week 24

  • Change in Cardiac Self-Efficacy (CSE)

    Baseline and week 24

  • Physical activity (PA) at work

    week 24

  • +1 more secondary outcomes

Study Arms (2)

RehaPlus+

EXPERIMENTAL

Customized motivational text messages twice weekly for six months

Behavioral: RehaPlus+

Usual care

NO INTERVENTION

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

Interventions

RehaPlus+BEHAVIORAL

24-week eHealth intervention

RehaPlus+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • language barriers
  • incapable of understanding study information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic Königsfeld

Ennepetal, North Rhine-Westphalia, 58256, Germany

Location

Related Publications (2)

  • 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.

    PMID: 37154363RESULT

  • 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.

    PMID: 39378432DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Quasi-experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 8, 2023

Study Start

September 1, 2021

Primary Completion

November 14, 2023

Study Completion

November 14, 2023

Last Updated

December 8, 2023

Record last verified: 2023-11

Locations

DE(1)