TIMELY Prospective Study

Study Overview
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Brief Summary
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Brief Summary: Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge. Main objectives of the study: To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes. To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.

Official Title
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TIMELY Prospective Study

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary Artery Disease (CAD) patients after myocardial infarction (STEMI/NSTEMI) and/or angioplasty and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery bypass graft surgery who participate in phase II Cardiac Rehabilitation (CR). Exclusion Criteria: Incapability to give informed consent Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease<br>Patients with Coronary Artery Disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiorespiratory Fitness (CRF) | CRF will be measured as maximal oxygen uptake (VO2max) determined by spiroergometry | Baseline, week 3, and week 24 | 
| Change in risk of mortality | Risk of mortality will be determined using the validated biomarker risk score COROPREDICT | Baseline, week 3, and week 24 | 
| Number of patients with major adverse cardiac and cerebrovascular events (MACCE) | Number of patients with death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization, and major bleeding | Baseline to week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity (PA) | PA will be measured by validated BSA questionnaire (Bewegungs- und Sportaktivität) and expressed as metabolic equivalents | Baseline, week 3, week 24, and week 48 | 
| Daily step count | Steps will be measured using electronic devices such as wrist-worn activity trackers | Baseline to week 24 | 
| Weekly number and duration of physical activities | Number and duration of physical activities will be measured using electronic devices such as wrist-worn activity trackers | Baseline to week 24 | 
| Resting heart rate | Resting heart rate will be measured using electronic devices such as wrist-worn activity trackers | Baseline to week 24 | 
| Sleep duration | Sleep duration will be measured using electronic devices such as wrist-worn activity trackers | Baseline to week 24 | 
| Physiological stress | Physiological stress will be measured using electronic devices such as wrist-worn activity trackers | Baseline to week 24 | 
| Blood pressure | Central and peripheral systolic and diastolic blood pressure will be measured using automatic upper-arm sphygmomanometers. Data transmitted by telemetry. | Baseline to week 24 | 
| Arterial pressure wave propagation/reflection characteristics | Arterial pressure wave propagation/reflection characteristics will be measured using automatic upper-arm tonometry. Data transmitted by telemetry. | Baseline to week 24 | 
| Cardiac arrhythmia | Cardiac arrhythmia will be measured using three-channel Holter ECG. | Baseline to week 24 | 
| Body composition | Body composition including fat mass, muscle mass, and visceral fat area will be measured by bioimpedance analysis. | Baseline, week 3, and week 24 | 
| Muscle strength | Arm and leg extension and flexion strength will be measured using Isokinetic devices | Baseline, week 3, and week 24 | 
| Muscle function | Muscle function will be measured by 30-second chair rise test | Baseline, week 3, and week 24 | 
| Submaximal exercise capacity | Submaximal exercise capacity will be measured using 6-min walking test | Baseline, week 3, and week 24 | 
| Habit formation | Habit formation will be assessed using validated questionnaire for the Self-Report Behavioural Automaticity Index (SRBAI). | Baseline, week 3, week 24, and week 48 | 
| Nicotine dependence | Nicotine dependence will be assessed using the Fagerström questionnaire | Baseline, week 3, week 24, and week 48 | 
| Cardiac Self-Efficacy | Cardiac Self-Efficacy will be assessed using the validated Cardiac Self-Efficacy Scale (CSE) | Baseline, week 3, week 24, and week 48 | 
| Impact of disease | Impact of disease will be assessed using the brief illness perception (IPQ-9) questionnaire . | Baseline, week 3, week 24, and week 48 | 
| General wellbeing | General wellbeing will be assessed using the Positive And Negative Affect Scale (PANAS) questionnaire . | Baseline, week 3, week 24, and week 48 | 
| Fear of Activity/ Kinesiophobia | Fear of Activity/ Kinesiophobia will be assessed using the modified Fear of Activity Scale (FActS). | Baseline, week 3, week 24, and week 48 | 
| Depression | Depression will be assessed using the modified Patient Health Questionnaire (PHQ-9). | Baseline, week 3, week 24, and week 48 | 
| General anxiety | General anxiety will be assessed using the 7-item General Anxiety Scale (GAD-7). | Baseline, week 3, week 24, and week 48 | 
| Health-related quality of life | Health-related quality of life will be assessed using the RAND 36-Item Health Survey (SF-36). | Baseline, week 3, week 24, and week 48 | 
| General quality of life | Quality of life will be assessed using the 5-level EQ-5D (EQ-5D-5L) health status measure. | Baseline, week 3, week 24, and week 48 | 
| Wellbeing | Wellbeing will be assessed using the WHO-5 Well-Being Index. | Baseline, week 3, week 24, and week 48 | 
| Perceived stress | Perceived stress will be assessed using the Perceived Stress Scale (PSS-4). | Baseline, week 3, week 24, and week 48 | 
| Optimism/ Pessimism | Optimism/ Pessimism will be assessed using the modified Life Orientation Test (LOT-R). | Baseline, week 3, week 24, and week 48 | 
| Conscientiousness | Conscientiousness will be assessed using the The Big Five Inventor (BFI-10). | Baseline, week 3, week 24, and week 48 | 
| Psychological flexibility | Psychological flexibility will be assessed using the psychometric properties of the Acceptance and Action Questionnaire-I (AAQ-II). | Baseline, week 3, week 24, and week 48 | 
| Negative Affectivity | Standard assessment of negative affectivity, social inhibition, and Type D personality (DS-14) | Baseline, week 3, week 24, and week 48 | 
| Trait anger | Trait anger will be assessed using the State-Trait Anger Expression Inventory-2 (TAI-10/STAXI-2). | Baseline, week 3, week 24, and week 48 | 
| Religiousness/ spirituality | Religiousness/ spirituality will be assessed using the Spiritual and Religious Attitudes in Dealing with Illness (GrAw-7/ SpREUK-15) questionnaire. | Baseline, week 3, week 24, and week 48 | 
| Fatigue | Fatigue will be assessed using the The Multidimensional Fatigue Inventory (MFI20). | Baseline, week 3, week 24, and week 48 | 
| Psychological situation in the working environment | Psychological situation in the working environment will be assessed using the The effort-reward imbalance model (ERI10+6). | Baseline, week 3, week 24, and week 48 | 
| Work requirements and workload | Work requirements and workload will be assessed using the Workability Index (WAI). | Baseline, week 3, week 24, and week 48 | 
| Social support | Social support will be assessed using the short Perceived Social Support Questionnaire (F-SozU K6). | Baseline, week 3, week 24, and week 48 | 
| Relationship satisfaction | Relationship satisfaction will be assessed using the Quality of Marriage Index (QMI). | Baseline, week 3, week 24, and week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Cardiac Rehabilitation, Healthy Lifestyle, Preventive Programs, Artificial Intelligence, Predictive Medicine, Continuum of Care, Maintenance, Aftercare, eHealth, mHealth