First patient enrolled in TIMELY trial
July 18, 2023 — The TIMELY consortium announced today the enrollment of the first patient in the randomized controlled clinical TIMELY trial. The TIMELY study investigates to what extent the AI-supported TIMELY platform improves the health of myocardial infarction (MI) patients and other patients with coronary heart disease after cardiac rehabilitation.
Around 1.8 million people in the European Union die each year from coronary heart disease.1 To prevent reinfarctions, patients receive cardiac rehabilitation to support necessary changes in lifestyle habits, such as diet and increased physical activity. However, clinical studies show that many find it very difficult to sustainably change their lifestyle and that adherence decreases with increasing time since rehabilitation.2 "We extensively educate patients who are hospitalized 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 behavioral patterns," Dr. Boris Schmitz from the DRV Klinik Königsfeld in Germany, and one of the lead investigators of the TIMELY trial, explains. "With our TIMELY platform, we want to support patients in maintaining a healthy lifestyle beyond rehabilitation and hospital stay in a self-reliant manner."
The integrative and multifunctional TIMELY platform has been developed as part of an EU-funded project by a total of 13 partners, including BIOTRONIK. It performs data analyses and risk assessment based on the guidelines for secondary prevention in coronary artery disease (CAD). Equipped with a blood pressure monitor, a so-called activity tracker, and an ECG patch, CAD patients transmit their vital parameters. Through a digital dashboard developed by the Berlin-based company Semdatex, doctors, therapists and case managers can access these values in the TIMELY platform and view the individual risk profile of their patients, which is automatically evaluated and interpreted. If necessary, care providers can then adjust the therapy.
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 also developed a digital coach whereby patients receive customized messages that are intended to be motivating and increase physical activity. Additionally, the platform offers the possibility to create weekly updated exercise plans and document goal achievements.
"I expect the study results to confirm the safety and effectiveness of the TIMELY platform and provide further insights into the use of telemedical systems in the field of behavior changes," says Dr. Jos Bosch, Professor of Psychology at the University of Amsterdam and coordinator of the TIMELY project.
The TIMELY study will enroll 360 patients at a total of three study centers in Germany, Spain and the Netherlands who have coronary artery disease with follow-up care as part of cardiac rehabilitation. The study will run until mid-2024, with the primary endpoint being a biomarker score (Coropredict) that reflects the risk of mortality in the next ten years, as well as the six-minute walk test for assessing physical fitness. Changes in diet and exercise behavior will also be analyzed.
"The telemedical secondary prevention of heart disease patients is already well-established in outpatient and inpatient settings," comments 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 post-heart attack patients low-threshold and continuous support, thereby providing more security and quality of life."
For more information: https://www.timely-project.com/
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 factor 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.