Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 9, 2024
Date Accepted: Mar 15, 2025
A patient-centered risk prediction, prevention and intervention platform to support the continuum of care in coronary artery disease using eHealth and artificial intelligence: The TIMELY Randomized controlled trial protocol
ABSTRACT
Background:
Cardiac rehabilitation (CR) programs show promising results in tertiary prevention. However, sustained behavioral changes remain a challenge.
Objective:
The TIMELY project aims to develop and evaluate a personalized artificial intelligence-driven eHealth platform and app to support sustainable behaviour change after CR and subsequently reduce the cardiac risk score.The primary outcomes will be: (1) the cardiac Coropredict risk score, which integrates various blood-based cardiac risk markers, and (2) function fitness level measured by the 6-miute walk test. Secondary outcomes include physical activity during daily life, cardiovascular exercise tolerance, dietary habits, body weight, smoking status, medication adherence, and perceived stress levels.
Methods:
An international multicenter randomized controlled trial will be conducted to evaluate the effectiveness of the TIMELY integrated platform and app. A total of 360 cardiac patients will be enrolled across three centers in Germany, Spain and The Netherlands. Patients will be randomized (1:1) to either the active intervention group or the control group. The intervention group will receive behavior change support through the TIMELY app, supported by the integrated platform, along with monitoring devices. Both groups will continue to receive care as usual, complete validated questionnaires, undergo physical tests, and provide blood samples. Assessments will be conducted at baseline, 3, 6, and 12-months follow up.
Results:
A total of 360 participants have been enrolled and randomized to intervention (N=180) and care as usual (N=180). The mean age of the sample is 61 years and 22% of the sample is female. Further data collection is still ongoing.
Conclusions:
This project will test a personalized platform and app, supported by artificial intelligence, designed to support health behavior change following CR. Multiple health behaviors will be addressed, with a main focus physical activity and fitness levels using an integrated approach. Clinical Trial: The TIMELY trial has been registered at www.clinicaltrials.gov (NCT05955625).
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