TIMELY Start: The first patient is enrolled
A new clinical trial in Europe investigates the applicability and efficacy of the new TIMELY platform for telemedical secondary prevention.
Berlin / Ennepetal / Santiago de Compostela / Tilburg - The TIMELY consortium today announced the enrollment of the first patient in the randomized, controlled TIMELY clinical trial. The TIMELY trial investigates the extent to which the AI-powered TIMELY platform improves the health status of heart attack patients and other patients with coronary artery disease after cardiac rehabilitation.
In the European Union, around 1.8 million people die from coronary heart disease every year[1] To prevent recurrent infarctions, patients receive cardiac rehabilitation to help them make the necessary lifestyle changes, such as changing their diet and increasing their physical activity. However, clinical studies show that many people find it very difficult to make lasting changes to their lifestyle and that adherence decreases with increasing time since rehabilitation.[2] "We provide patients who come into hospital after a heart attack with detailed information about the risk factors and show them how important it is to make lasting changes to their lifestyle - including more exercise, a healthier diet and no more nicotine consumption. But when the patients come for a follow-up examination six months later, it often turns out that they have fallen back into their old patterns of behavior," explains Dr. Boris Schmitz from the DRV Klinik Königsfeld and one of the study leaders of the TIMELY study. "With our TIMELY platform, we want to support patients in leading a healthy lifestyle under their own responsibility even after rehabilitation and hospitalization."
The integrative and multifunctional TIMELY platform was developed by a total of 13 partners as part of an EU-funded project. It carries out data analyses and risk assessments based on the guidelines for secondary prevention of coronary heart disease (CHD). Equipped with a blood pressure monitor, an activity tracker and an ECG patch, CHD patients transmit their vital parameters. Using a digital dashboard developed by the Berlin-based company Semdatex, doctors, therapists and case managers can call up these values in the TIMELY platform and view their patients' individual risk profile, which is automatically evaluated and interpreted. Caregivers can then adjust the therapy if necessary.
The TIMELY platform offers numerous other functions for patients: With the help of artificial intelligence, they receive individually tailored recommendations for a healthy lifestyle. A personalized chatbot developed by the University of Amsterdam assists patients and supports them in implementing the recommendations. The University of Amsterdam has also developed a digital coach that sends patients tailored messages to motivate them and increase their physical activity. The platform also offers the option of creating weekly updated training plans and documenting the achievement of goals.
"I expect the study results to confirm the safety and efficacy of the TIMELY platform and provide further insights into the use of telemedicine systems in the field of behavior change," says Dr. Jos Bosch, Professor of Psychology at the University of Amsterdam and coordinator of the TIMELY project.
The TIMELY study will enrol 360 patients suffering from coronary heart disease and receiving cardiac rehabilitation at a total of three study centers in Germany, Spain and the Netherlands. The primary endpoint is a biomarker score (Coropredict), which reflects the risk of death in the next 10 years, as well as the 6-minute walk test to assess physical fitness. Changes in diet and exercise habits will also be analyzed.
"The telemedical secondary prevention of heart patients is already well established in the outpatient and inpatient sector," says Roberto Belke, Managing Director of BIOTRONIK Germany, "I am convinced that it is now time to rethink the field of rehabilitation. With the TIMELY platform, we offer patients continuous support without thresholds after a heart attack, thus ensuring greater safety and quality of life."
References:
1. European Society of Cardiology: Cardiovascular Disease Statistics 2019
2. Kotseva et al; EUROASPIRE Investigators. EUROASPIRE IV: A European Society of Cardiology survey on the lifestyle, risk factors and therapeutic management of coronary patients from 24 European countries. Eur J Prev Cardiol. 2016 Apr;23(6):636-48. doi: 10.1177/2047487315569401. Epub 2015 Feb 16. PMID: 25687109.
About TIMELY
The TIMELY project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement ID: 101017424. Further information can be found under this Link.