TIMELY: A Patient-centred Lifestyle Program to Support the Continuum of Care in Patients With Coronary Artery Disease Using eHealth and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 358
- 试验地点
- 6
- 主要终点
- Change in risk of mortality
研究概览
简要总结
Study design: A randomized controlled trial will be used, where patients will be randomized (1:1) to either the control group receiving usual care or the intervention group in which patients will receive usual care in combination with the TIMELY intervention for a duration of 6 months.
Study sample: Female and male patients aged 18 years or over, with documented stable CAD and referred for cardiac rehabilitation (at > 2 weeks but <10 weeks after PCI or >4 weeks but <12 weeks after CABG or MI: STEM or non-STEMI), and/or having documented CAD by coronary angiography (stenosis in a major coronary artery >50%).
Intervention: Patients randomized to the intervention group will receive the TIMELY app on their phones or tablets for 6 months. Patients will also receive a wearable activity tracker that collects activity levels, heart rate and sleep characteristics. Based on patient's activity levels, self-reported momentary mental states, health-related behaviors and environmental and clinical background factors, the app will enable patient-tailored recommendations relevant to improving lifestyle behaviors during daily life. In addition, patients will receive a blood pressure monitor that measures hemodynamic parameters through pulse wave analysis and an easy-to-use ECG device which will be used to assess changes in heart rate and other cardiovascular measures at rest and with exercise.
Main study parameters/endpoints: The primary biomedical outcome is a change in the CoroPredict biomarker risk score from baseline (pre-randomization) to completion of the active intervention phase (6 months). The CoroPredict score is an indicator of the 10-year risk of mortality. The primary behavioral outcome is the change from baseline to 6 months in patients' functional status of fitness level (measured using the 6-minute walk test). The study further aims to improve secondary outcome measures: physical activity levels during daily life and cardiovascular responses to exercise, dietary habits, smoking behavior, medication adherence and perceived levels of psychological stress.
详细描述
Background of the study:
Cardiovascular diseases (CVD) are the leading cause of death globally according to the WHO. The highest burden of disease among CVDs is caused by coronary artery disease (CAD). Ageing predisposes patients to a high incidence and prevalence of CAD, in both men and women. Older patients have the greatest mortality and morbidity risk attributable to Chronic Coronary Syndromes (CCS), partially due to the high prevalence of comorbidities. Secondary prevention through comprehensive cardiac rehabilitation (CR) has been recognized as the most cost-effective intervention to limit the physiological and psychological effects of CVDs and reduce the risk of future cardiovascular events.
Contrary to pharmacological or invasive interventions for CAD, CR is far from being well implemented in all European countries and participation rates in available programs range between 30-50% of eligible patients. The TIMELY platform has been developed to stimulate a healthy lifestyle after CR. Patient-related barriers for digital health mainly involve the usability of the CR platform, especially for older patients. Thus, TIMELY includes digital tools and interfaces that will not hinder senior citizens from using them, as patient co-design has guided the development. Since lifestyle changes are key in the prevention and self-management of CAD, the main component of the TIMELY platform will be an app built on behavioral change techniques and models to empower and motivate patients to adopt a healthy lifestyle. Artificial intelligence (AI) will be employed to adapt the platform to the most current needs of the patient. In addition to prevention and self-management, the TIMELY platform will constantly monitor and predict the individual risk for disease progression or serious events and complications using validated risk scores (CoroPredict®). TIMELY will become the first AI-powered, patient-centered eHealth platform that continuously adapts and customizes CR to meet the needs of patients.
Objective of the study:
1. To investigate whether the TIMELY intervention is superior to usual care in terms of A) reducing the CoroPredict risk score (indicating risk of 10-year mortality: primary biomedical outcome) from baseline to six months; and B) increasing functional fitness levels (6-minute walk test); primary behavioral outcome) from baseline to 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Because this is a behavioral intervention, the participants and clinicians cannot be blinded to the treatment condition they are randomized to. However, the evaluation of the outcome measures will be done with researchers blinded to the treatment condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and over (there is no a priori upper age limit)
- •Documented stable CAD and referred for cardiac rehabilitation (at > 2 weeks but < 10 weeks after PCI or > 4 weeks but <12 weeks after CABG or MI: STEMI or non-STEMI) and/or having documented CAD by coronary angiography (stenosis in a major coronary artery > 50%)
- •Access and ability to operate a smartphone
- •Able to speak the country's native language
排除标准
- •Unable to fully understand the provided study information and consequences of participating in the study
- •Presence of a physical impairment interfering with the use of the app or devices (e.g., blindness, wheelchair bound)
- •Known diagnosis of an active malignant tumour (cancer) or any other medical condition associated with a life expectancy of less than one year
- •Unstable cardiovascular, cerebrovascular or other unstable medical condition
- •Refusal to informed consent
- •Having a pacemaker
结局指标
主要结局
Change in risk of mortality
时间窗: Baseline and 6 months
Risk of mortality will be determined using the validated biomarker risk score CoroPredict, indicating 10-year mortality probability.
Change in functional fitness levels
时间窗: Baseline and 6 months
Functional fitness levels will be assessed using the 6-minute walking test, using the number of meters walked as the outcome.
次要结局
- Change in physical activity(Baseline, 3 months and 6 months)
- Change in weight(Baseline and 6 months)
- Change in smoking cessation(Baseline, 3 months and 6 months)
- Change in medication adherence(Baseline, 3 months and 6 months)
- Change in psychological stress levels(Baseline, 3 months, 6 months)
- Change in cardiovascular exercise tolerance(Baseline and 6 months)
- Change in healthy dietary habits(Baseline, 3 months and 6 months)