Periodic Reporting for period 3 - TIMELY (A patient-centered early risk prediction, prevention, and intervention platform to support the continuum of care in coronary artery disease (CAD) using eHealth and artificial intelligence)
Periodo di rendicontazione: 2024-01-01 al 2025-03-31
Coronary artery disease (CAD) remains the leading cause of death and disability worldwide. It progresses over decades and is driven by modifiable risk factors such as hypertension, smoking, physical inactivity, and obesity, along with genetic predisposition. While medical and invasive treatments are well-integrated in clinical practice across Europe, long-term support for self-care and secondary prevention is still fragmented or absent—especially for older and high-risk populations.
This care gap limits patients' ability to maintain healthy behaviors and manage their condition post-rehabilitation, increasing the risk of relapse and placing further strain on healthcare systems. There is a clear societal need for scalable, personalized, and accessible tools to support long-term cardiac health and reduce preventable hospitalizations and complications.
TIMELY responds to this need with a digital platform combining artificial intelligence (AI), mobile health tools, and wearable medical devices to deliver individualized cardiac rehabilitation support. It includes patient-facing apps, remote monitoring, behavior change coaching, and a clinician dashboard with AI-powered decision support. The platform enables case managers to monitor patient data in real time, detect risks, and intervene early.
TIMELY is designed as a modular, interoperable solution that can be integrated into different European healthcare systems, including those with fragmented services. The platform is co-developed in a living lab with vulnerable patient groups, guided by behavioral scientists and psychologists to ensure usability and equity. Its goal is to empower patients, improve long-term outcomes, and support the sustainability of cardiovascular care in Europe.
This care gap limits patients' ability to maintain healthy behaviors and manage their condition post-rehabilitation, increasing the risk of relapse and placing further strain on healthcare systems. There is a clear societal need for scalable, personalized, and accessible tools to support long-term cardiac health and reduce preventable hospitalizations and complications.
TIMELY responds to this need with a digital platform combining artificial intelligence (AI), mobile health tools, and wearable medical devices to deliver individualized cardiac rehabilitation support. It includes patient-facing apps, remote monitoring, behavior change coaching, and a clinician dashboard with AI-powered decision support. The platform enables case managers to monitor patient data in real time, detect risks, and intervene early.
TIMELY is designed as a modular, interoperable solution that can be integrated into different European healthcare systems, including those with fragmented services. The platform is co-developed in a living lab with vulnerable patient groups, guided by behavioral scientists and psychologists to ensure usability and equity. Its goal is to empower patients, improve long-term outcomes, and support the sustainability of cardiovascular care in Europe.
A fully functional, GDPR-compliant digital health platform has been successfully developed and validated within the TIMELY project. The system was tested in a 12-month multicenter randomized controlled trial involving 358 patients across three countries—Germany, Spain, and the Netherlands—targeting individuals with coronary artery disease (CAD) following cardiac rehabilitation. The platform integrates mobile applications, wearable sensors, AI-based decision support, and real-time remote monitoring, coordinated by trained case managers in a human-in-the-loop model of care.
Key outcomes of the clinical evaluation demonstrate robust safety and high user acceptability, particularly in Spain, where the intervention aligned closely with local digital infrastructure and health policy. Participants reported strong satisfaction with the system’s usability and support features. While the intervention did not lead to statistically significant improvements over usual care in primary outcomes (i.e. CoroPredict 10-year cardiovascular risk score, 6-minute walk test), both groups showed short-term improvements, and the intervention group demonstrated greater engagement and perceived benefit of cardiac rehabilitation.
TIMELY also delivered major innovations in digital health technology. AI models were trained and validated using trial data to predict key outcomes such as major adverse cardiac and cerebrovascular events (MACCE), mortality, CR adherence, and clinical improvement. The platform features an AI-assisted exercise prescription engine, advanced ECG and pulse wave analytics for arrhythmia detection, and a hybrid chatbot capable of delivering tailored behavioral coaching in multiple languages.
Dissemination has been a major strength of the project, with more than 40 peer-reviewed scientific publications, over 15 conference presentations—including at leading venues such as the European Society of Cardiology (ESC) and IEEE—and an outreach campaign generating over 112,000 media impressions. Patient workshops, clinical partner events, and policy dialogues have supported awareness and engagement at the user and system levels.
The project’s exploitation strategy includes commercialization plans for the integrated platform, regulatory pathways for certification, and targeted market entry in Spain, Germany, and the Netherlands.
With its modular design, clinical validation, and demonstrated patient acceptance, the TIMELY platform is now ready for scale-up and integration into diverse healthcare systems. The supporting health technology assessment and policy brief offer a comprehensive roadmap for policymakers and payers seeking cost-effective, scalable digital solutions for long-term cardiac care.
Key outcomes of the clinical evaluation demonstrate robust safety and high user acceptability, particularly in Spain, where the intervention aligned closely with local digital infrastructure and health policy. Participants reported strong satisfaction with the system’s usability and support features. While the intervention did not lead to statistically significant improvements over usual care in primary outcomes (i.e. CoroPredict 10-year cardiovascular risk score, 6-minute walk test), both groups showed short-term improvements, and the intervention group demonstrated greater engagement and perceived benefit of cardiac rehabilitation.
TIMELY also delivered major innovations in digital health technology. AI models were trained and validated using trial data to predict key outcomes such as major adverse cardiac and cerebrovascular events (MACCE), mortality, CR adherence, and clinical improvement. The platform features an AI-assisted exercise prescription engine, advanced ECG and pulse wave analytics for arrhythmia detection, and a hybrid chatbot capable of delivering tailored behavioral coaching in multiple languages.
Dissemination has been a major strength of the project, with more than 40 peer-reviewed scientific publications, over 15 conference presentations—including at leading venues such as the European Society of Cardiology (ESC) and IEEE—and an outreach campaign generating over 112,000 media impressions. Patient workshops, clinical partner events, and policy dialogues have supported awareness and engagement at the user and system levels.
The project’s exploitation strategy includes commercialization plans for the integrated platform, regulatory pathways for certification, and targeted market entry in Spain, Germany, and the Netherlands.
With its modular design, clinical validation, and demonstrated patient acceptance, the TIMELY platform is now ready for scale-up and integration into diverse healthcare systems. The supporting health technology assessment and policy brief offer a comprehensive roadmap for policymakers and payers seeking cost-effective, scalable digital solutions for long-term cardiac care.
TIMELY has advanced beyond the state of the art by developing a clinically validated, AI-powered, modular eHealth platform for long-term secondary prevention in coronary artery disease (CAD). Unlike existing digital CR tools that offer limited personalization or integration, TIMELY combines mobile health applications, wearable sensors, AI-based decision support, and human-in-the-loop case management into a seamless, patient-centered system. It is interoperable with electronic health records, compliant with GDPR and adaptable across diverse European healthcare systems.
Key innovations include predictive AI models for cardiovascular events and patient adherence, an intelligent exercise prescription engine, and multi-language chatbot-guided behavior change support. The platform was tested in a large, cross-national randomized controlled trial, demonstrating safety, high user satisfaction, and engagement—especially among digitally literate users.
The societal and economic impact of TIMELY is substantial. The platform enables more equitable access to cardiac rehabilitation by reaching patients who are often excluded from traditional, center-based care, such as those in rural areas, older adults, and people with limited mobility. By empowering patients with digital tools and remote support, TIMELY facilitates lifestyle change, improves adherence to care plans, and helps prevent recurrent cardiovascular events. In doing so, it can reduce long-term healthcare costs, decrease reliance on hospital-based services, and ease pressure on overstretched clinical resources. Moreover, by promoting digital literacy and personalized prevention, TIMELY contributes to healthier aging, patient empowerment, and more sustainable healthcare systems. These impacts align with EU priorities for digital transformation, health equity, and chronic disease prevention, and position TIMELY as a scalable solution to support cardiovascular health across Europe.
Key innovations include predictive AI models for cardiovascular events and patient adherence, an intelligent exercise prescription engine, and multi-language chatbot-guided behavior change support. The platform was tested in a large, cross-national randomized controlled trial, demonstrating safety, high user satisfaction, and engagement—especially among digitally literate users.
The societal and economic impact of TIMELY is substantial. The platform enables more equitable access to cardiac rehabilitation by reaching patients who are often excluded from traditional, center-based care, such as those in rural areas, older adults, and people with limited mobility. By empowering patients with digital tools and remote support, TIMELY facilitates lifestyle change, improves adherence to care plans, and helps prevent recurrent cardiovascular events. In doing so, it can reduce long-term healthcare costs, decrease reliance on hospital-based services, and ease pressure on overstretched clinical resources. Moreover, by promoting digital literacy and personalized prevention, TIMELY contributes to healthier aging, patient empowerment, and more sustainable healthcare systems. These impacts align with EU priorities for digital transformation, health equity, and chronic disease prevention, and position TIMELY as a scalable solution to support cardiovascular health across Europe.