Effects of an AI-powered eHealth intervention on physical capacity and self-management in coronary artery disease: the TIMELY multicenter RCT
Key result
TIMELY eHealth intervention shows no ITT benefit over usual care, but improves per-protocol walking distance.
- P<0.05
- n=360
Why the study?
eHealth solutions offer avenues for optimizing personalized care in CAD, and TIMELY is the first AI-driven eHealth intervention grounded in cardiac rehabilitation principles and integrated with IoT technology whose randomized outcomes needed to be evaluated.
Does a 6-month AI-powered eHealth intervention (TIMELY) improve mortality risk biomarker scores and 6-minute walking test distance compared to usual care in patients with coronary artery disease during phase III cardiac rehabilitation?
Key Points
- To evaluate the efficacy of the AI-driven eHealth intervention TIMELY in improving physical capacity, self-management, and mortality risk during phase III cardiac rehabilitation.
- Multicenter randomized controlled trial conducted across Germany, Spain, and the Netherlands enrolling 360 patients with coronary artery disease (mean age 60.5±9.2 years; 21% women; 34% with prior myocardial infarction).
- Participants were randomized to either a 6-month app-based behavioral change program incorporating AI risk prediction, chatbot support, and IoT monitoring devices (n=180) or usual care (n=180), with follow-up at 6 and 12 months.
- Primary outcomes included changes in mortality risk assessed by a composite biomarker score and 6-minute walking test (6MWT) distance.
- Intention-to-treat analysis revealed no significant between-group differences for primary outcomes, including biomarker-based mortality risk assessment and 6-minute walking test distance.
- Per-protocol analysis showed the intervention group maintained approximately 7% superior 6-minute walking test performance over 12 months (567.5±90.3 m vs. 529.6±111.7 m; p<0.05).
- The intervention group exhibited greater physical fitness at 6 months (144.5±39.6 W vs. 130.9±44.0 W) and 12 months (141.9±45.2 W vs. 130.3±45.2 W; interaction p=0.027), alongside higher medication adherence at 12 months (interaction p=0.0071).
Study Design
Type
RCT (n=360)
Randomization
Randomized 1:1 (n=180 per group)
Multicenter
Yes
Structured PICO
Does a 6-month AI-powered eHealth intervention (TIMELY) improve mortality risk biomarker scores and 6-minute walking test distance compared to usual care in patients with coronary artery disease during phase III cardiac rehabilitation?
P
Population
360 patients with coronary artery disease (mean age 60.5 years, 21% women, 34% prior MI) in Germany, Spain, and the Netherlands entering phase III cardiac rehabilitation aftercare, followed for 12 months.
I
Intervention
TIMELY AI-powered eHealth intervention: a 6-month app-based behavior change and self-management program as part of phase III cardiac rehabilitation aftercare, integrating clinical/psychosocial data, chatbot, individualized exercise prescriptions via Ecological Momentary Assessment (EMA), and IoT devices (activity tracker, blood pressure monitor, and 3-channel Holter monitor connected to a cloud-based platform and case manager dashboard) (n=180).
C
Comparator
Usual care during phase III cardiac rehabilitation aftercare (n=180).
O
Outcome
Changes in mortality risk (assessed via a composite biomarker score) and 6-minute walking test (6MWT) distance assessed at 6 and 12 months.surrogate
Main Result
Absolute Event Rate: 567.5% vs 529.6%
p-value: p=<0.05
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We extensively educate patients who are hospitalised after a myocardial infarction about the risk factors and show them how important it is to make lasting changes in lifestyle—including more exercise, a healthier diet, no more nicotine consumption. And yet, when patients come for a follow-up examination six months later, it often turns out that they have relapsed into their old behavioural patterns.”
“If the system detects a change in risk, we can initiate targeted intervention measures. The vision is for the system to recognise changes at an early stage and take customised countermeasures. Initially, this involves encouraging healthy behaviour such as more exercise and a healthy diet.”
“Lifestyle is key to improving cardiovascular health, but it's not always easy to make the necessary changes. With TIMELY, we want to support both patients and physicians to better manage the risk factors and thus improve health outcomes and quality of life. We hope to make our TIMELY solution available to all CAD patients in the nearest future.”
Implication
Although the TIMELY AI-driven eHealth intervention did not meet its primary endpoints in the intention-to-treat analysis, it significantly improved secondary measures of physical fitness and medication adherence, as well as per-protocol 6-minute walk distance, in patients with coronary artery disease.
Abstract
Background eHealth solutions offer promising avenues for optimizing personalized care and supporting disease management in patients with coronary artery disease (CAD). TIMELY represents the first artificial intelligence (AI)-driven eHealth intervention grounded in cardiac rehabilitation (CR) principles and integrated with Internet of Things (IoT) technology. Purpose To report the outcomes of the TIMELY RCT. Methods TIMELY is a multicenter RCT conducted in Germany, Spain, and the Netherlands, enrolling 360 CAD patients. Participants randomized to the intervention group (IG, n=180) received a 6-month app-based behavior change program as part of phase III CR aftercare, while control group (CG) participants received usual care. Assessments occurred at baseline, 6, and 12 months. The TIMELY platform supports behavior change and self-management by integrating clinical and psychosocial data, evaluating risk, and delivering personalized feedback via app-based prompts. Physical activity engagement is facilitated through a chatbot and individualized exercise prescriptions derived from weekly activity profiles, utilizing Ecological Momentary Assessment (EMA). Participants were equipped with an activity tracker, blood pressure monitor, and 3-channel Holter monitor, all connected to an integrative cloud-based platform. AI algorithms optimize CAD risk prediction and behavioral recommendations, with data displayed on a dashboard accessible to case managers. Primary outcomes were changes in mortality risk (assessed via a composite biomarker score) and 6-minute walking test (6MWT) distance. Secondary outcomes included physical fitness, physical activity levels, dietary habits, body weight, smoking cessation, medication adherence, and psychological stress. Results Mean participant age was 60.5±9.2 years; 34% had a history of MI, and 21% were women. At 6 months, 161 (89%) IG and 156 (87%) CG participants completed primary outcome assessments. Twenty-eight serious adverse events occurred, none attributable to the intervention. Intention-to-treat analysis revealed no significant between-group differences for primary outcomes including biomarker-based risk assessment. However, per-protocol analysis demonstrated that the IG maintained approximately 7% superior 6MWT performance over 12 months (IG=567.5±90.3 m vs. CG=529.6±111.7 m; p<0.05). The IG also exhibited greater improvements in physical fitness (time×group interaction, p=0.027), with higher values at 6 months (IG=144.5±39.6 W vs. CG=130.9±44.0 W) and 12 months (IG=141.9±45.2 W vs. CG=130.3±45.2 W). Medication adherence (MARS-5 score) remained significantly higher in the IG at 12 months (interaction, p=0.0071). No other significant between-group differences were observed for secondary outcomes. Conclusions The AI-driven eHealth intervention TIMELY provides personalized support for CAD patients during phase III CR and demonstrates promise for improving physical exercise capacity.
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Cite This Study
Schmitz et al. (2026) conducted an RCT in Coronary artery disease (n=360). TIMELY AI-driven eHealth behavior change program vs. Usual care was evaluated on Changes in mortality risk (composite biomarker score) and 6-minute walking test (6MWT) distance (p=<0.05). The TIMELY AI-driven eHealth intervention showed no ITT difference in primary outcomes, but improved per-protocol 12-month 6MWT distance vs usual care (567.5 vs 529.6 m; p<0.05).