Why the study?
Cardiac rehabilitation programs show promising results in tertiary prevention, but achieving sustained behavioral changes remains a challenge.
Does a personalized, AI-driven eHealth platform and app (TIMELY) improve 10-year mortality risk score and 6-minute walking distance in patients with stable CAD undergoing cardiac rehabilitation?
RCT (n=358)
Open-label with blinded outcome assessment
1:1
Yes
Does a personalized, AI-driven eHealth platform and app (TIMELY) improve 10-year mortality risk score and 6-minute walking distance in patients with stable CAD undergoing cardiac rehabilitation?
The TIMELY trial will evaluate whether an AI-driven eHealth platform can improve cardiovascular risk scores and functional capacity in patients with coronary artery disease undergoing cardiac rehabilitation.
Answers are grounded in this paper and cite their sources.
May inform AI eHealth integration into cardiac rehab if effective; leaves open efficacy in stable CAD.
BACKGROUND: Cardiac rehabilitation (CR) programs have shown promising results in tertiary prevention. However, achieving sustained behavioral changes remains a challenge. OBJECTIVE: The TIMELY project aims to develop and evaluate a personalized, artificial intelligence-driven eHealth platform and app to support sustainable behavior change during phase-3 CR, subsequently reducing cardiac risk scores. 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 patients with cardiac conditions will be approached to participate in the study across Germany, Spain, and the Netherlands. Patients will be randomly assigned (1:1) to either the intervention group or the control group (care as usual). The intervention group will receive fully web-based, behavior change support through the TIMELY app, with personalized exercise prescription, chatbot assistance, and monitoring devices (eg, activity watch). 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 and at 3, 6, and 12 months. RESULTS: Trial recruitment has been finalized in July 2024. A total of 358 patients have been recruited and randomly assigned to the intervention (n=180, 50.1%) or care-as-usual (n=178, 49.7%) condition. As of January 2025, the 6-month follow-up has been completed for all participants. Follow-up data collection will be completed in May 2025. Results regarding the primary and secondary objectives are expected in September 2025. CONCLUSIONS: This project will test a personalized platform and app, supported by artificial intelligence and designed to support health behavior change during phase-3 CR. It will target multiple health behaviors, with a primary focus on physical activity and fitness levels, using an integrated approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT05955625; https://clinicaltrials.gov/ct2/show/NCT05955625. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66283.
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Habibović et al. (2025) conducted an RCT in Coronary Artery Disease (n=358). TIMELY personalized eHealth platform and app vs. Care as usual was evaluated on Change in 10-year mortality risk (CoroPredict score) and 6-minute walking test distance from baseline to 6 months.
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