Periodic Reporting for period 2 - 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: 2022-07-01 al 2023-12-31
Coronary artery disease (CAD) remains the leading cause of disease burden globally. CAD develops slowly, usually over decades, and depends on multiple (often modifiable) risk factors and their interactions also with individual disease predisposition. While the disease-centered evidence-based pharmacological and invasive interventions for CAD are well implemented at the clinical end, patient’s self-care assistance for disease control and prevention of CAD progression is highly fragmented across the European Union if implemented at all.
TIMELY is a platform that provides Artificial Intelligence (AI)-powered dashboards and decision support tools assisting patients and clinicians to personalize healthcare based on risk evaluation, outcome prediction and target interventions. TIMELY provides patient-centered eHealth tools (apps, IoT medical devices, communication), for patient empowerment and guidance during behavioral change interventions and healthy living, to manage their condition. The platform will be developed based on a CE-certified integrative database for Interoperability with electronic health records and security mechanisms, will ensure information completeness and continuity and will simplify data sharing. In any case, the TIMELY eHealth platform will be administered by a case manager supported by Artificial Intelligence, that will constantly monitor and evaluate risks and will indicate any deviation from defined therapy goals or unfavorable changes.
TIMELY will be developed as a modular and flexible platform that can be applied to provide health service for CAD patients across Europe also in countries with fragmented health service availability. The platform will be developed together with the most vulnerable and sensitive (in terms of technical assistance) group of CAD patients, i.e. those at higher risk due to ageing and comorbidities in the setting of inpatient cardiac rehabilitation. Behavioral scientists and medical/clinical psychologists will lead this task in an open innovation, living lab condition.
TIMELY is a platform that provides Artificial Intelligence (AI)-powered dashboards and decision support tools assisting patients and clinicians to personalize healthcare based on risk evaluation, outcome prediction and target interventions. TIMELY provides patient-centered eHealth tools (apps, IoT medical devices, communication), for patient empowerment and guidance during behavioral change interventions and healthy living, to manage their condition. The platform will be developed based on a CE-certified integrative database for Interoperability with electronic health records and security mechanisms, will ensure information completeness and continuity and will simplify data sharing. In any case, the TIMELY eHealth platform will be administered by a case manager supported by Artificial Intelligence, that will constantly monitor and evaluate risks and will indicate any deviation from defined therapy goals or unfavorable changes.
TIMELY will be developed as a modular and flexible platform that can be applied to provide health service for CAD patients across Europe also in countries with fragmented health service availability. The platform will be developed together with the most vulnerable and sensitive (in terms of technical assistance) group of CAD patients, i.e. those at higher risk due to ageing and comorbidities in the setting of inpatient cardiac rehabilitation. Behavioral scientists and medical/clinical psychologists will lead this task in an open innovation, living lab condition.
Within the living lab, we have conducted a prospective observational study with CAD patients in phase II and III CR and collected high-resolution EHR, lifestyle, psychosocial, physical fitness, ECG, haemodynamic parameters, physical activity and MACCE data for over 600 patients (260 of them used the TIMELY devices for 6 months). Over 300 patients have a 6-month follow-up, over 250 patients have a 12-month follow up. The data lake is feeding all WP2 and WP3 tasks. In addition, a retrospective data set was generated by screening EHR of > 16.000 CVD patients for patients with at least two visits during the past 10 years in Clinic Königsfeld.
Meanwhile AI methods and models for the automated evaluation of patients’ risks (MACCE and mortality with machine learning, arrythmias with ECG and PWA analysis, AF with ECG) as well as their expected response and adherence to CR programs have been developed with retrospective datasets (SERGAS, LURIC, GETABI, H-ADL, VIVIT, UK Biobank, EUCARE) with promising accuracies, above 80%.
As part of the TIMELY platform, patients are provided with AI-powered apps. These apps serve three main functions. First, these apps act as diary-like assessment tools. Second, the coaching app provides motivating messages (or ‘nudges’), that are based on a range of validated behaviour change techniques. AI is used to deliver these messages in a personalized and context-dependent manner. Finally, a chatbot app has been developed that is able to engage with brief motivating conversations, allowing a more in-depth assessment of barriers to chance lifestyle, and providing counselling interventions that draw from multiple therapeutic frameworks and approaches, such as motivational interviewing, self-determination theory, and cognitive behavioural therapy. Key to secondary prevention the increase of cardiovascular fitness. Based on guidelines and powered by machine and reinforcement learning methods, another app has been developed that dynamically adapts the dosage and intensity of exercise training.
The clinical protocol has been revised and finalised and eventually approved by the local ethics committees in Witten, Santiago de Compostela and Tilburg. The intervention which was classified as a medical device by the METC Brabant in which the sponsor TiU has applied, necessitated compliance with specific regulations, notably MDR - Article 82 on clinical investigations. The intervention is given though the TIMELY-Net dashboard. The platform consists of a central back-end server, handling all the communication to AI microservices, import of measurement data and exchange with the patient portal, which is realized as mobile app for Android phones and iPhones. ~50% of the recruitment is completed by end of Feb 2024 and all 360 are expected to be recruited by end of April, latest end of May 2024.
Meanwhile AI methods and models for the automated evaluation of patients’ risks (MACCE and mortality with machine learning, arrythmias with ECG and PWA analysis, AF with ECG) as well as their expected response and adherence to CR programs have been developed with retrospective datasets (SERGAS, LURIC, GETABI, H-ADL, VIVIT, UK Biobank, EUCARE) with promising accuracies, above 80%.
As part of the TIMELY platform, patients are provided with AI-powered apps. These apps serve three main functions. First, these apps act as diary-like assessment tools. Second, the coaching app provides motivating messages (or ‘nudges’), that are based on a range of validated behaviour change techniques. AI is used to deliver these messages in a personalized and context-dependent manner. Finally, a chatbot app has been developed that is able to engage with brief motivating conversations, allowing a more in-depth assessment of barriers to chance lifestyle, and providing counselling interventions that draw from multiple therapeutic frameworks and approaches, such as motivational interviewing, self-determination theory, and cognitive behavioural therapy. Key to secondary prevention the increase of cardiovascular fitness. Based on guidelines and powered by machine and reinforcement learning methods, another app has been developed that dynamically adapts the dosage and intensity of exercise training.
The clinical protocol has been revised and finalised and eventually approved by the local ethics committees in Witten, Santiago de Compostela and Tilburg. The intervention which was classified as a medical device by the METC Brabant in which the sponsor TiU has applied, necessitated compliance with specific regulations, notably MDR - Article 82 on clinical investigations. The intervention is given though the TIMELY-Net dashboard. The platform consists of a central back-end server, handling all the communication to AI microservices, import of measurement data and exchange with the patient portal, which is realized as mobile app for Android phones and iPhones. ~50% of the recruitment is completed by end of Feb 2024 and all 360 are expected to be recruited by end of April, latest end of May 2024.
TIMELY will help to collect, integrate and interpret the large amount of already available patient-level data, also collected outside clinical and medical environments, and provide new streams of complex biomedical data for incorporation into practices and clinics to unfold the full potential of modern health care. TIMELY provides beyond state-of-the art continuous risk stratification, prediction of low adherence and/or effectiveness of the interventions and uses autonomous agents and AI chatbots to provide target interventions for optimizing CR core components.
TIMELY will conduct an RCT to provide best evidence for the effectiveness and cost-effectiveness of the proposed AI-powered, eHealth solution. TIMELY will also promote best practices and reduce variation of care delivery around Europe. TIMELY aims to provide better management of patients with diagnosis of coronary syndromes and comorbidities. The incremental value of using risk scores, such as Coropredict and AI-based, to evaluate patients' risks, and more importantly configure the eHealth components will be further evaluated within the project. TIMELY will offer effective secondary prevention services along the coronary heart disease pathway based on teaching self-management, adopting healthy behaviors including regular exercise, controlling biomedical indices and adhering to cardioprotective medicines. Patient activation and health literacy can relieve health systems from the cardiac disease epidemic.
For the care systems TIMELY can have an impact by facilitating and increasing referrals and enrolment in CR, as well as by increasing participation in it. In terms of secondary prevention TIMELY can lead to less readmissions, reduced recurrent cardiovascular events and reduced mortality rate. Which in turn will produce societal benefits such as increased productivity, reduced absenteeism from work and social events, reduced burden for caregivers and healthcare providers, cost efficacy compared to current care, better management of healthcare resources and reduced costs for medication and/or invasive procedures.
TIMELY will conduct an RCT to provide best evidence for the effectiveness and cost-effectiveness of the proposed AI-powered, eHealth solution. TIMELY will also promote best practices and reduce variation of care delivery around Europe. TIMELY aims to provide better management of patients with diagnosis of coronary syndromes and comorbidities. The incremental value of using risk scores, such as Coropredict and AI-based, to evaluate patients' risks, and more importantly configure the eHealth components will be further evaluated within the project. TIMELY will offer effective secondary prevention services along the coronary heart disease pathway based on teaching self-management, adopting healthy behaviors including regular exercise, controlling biomedical indices and adhering to cardioprotective medicines. Patient activation and health literacy can relieve health systems from the cardiac disease epidemic.
For the care systems TIMELY can have an impact by facilitating and increasing referrals and enrolment in CR, as well as by increasing participation in it. In terms of secondary prevention TIMELY can lead to less readmissions, reduced recurrent cardiovascular events and reduced mortality rate. Which in turn will produce societal benefits such as increased productivity, reduced absenteeism from work and social events, reduced burden for caregivers and healthcare providers, cost efficacy compared to current care, better management of healthcare resources and reduced costs for medication and/or invasive procedures.