Clinical trial NCT05461729: TIMELY Prospective Study
Official title: TIMELY Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Cardiac Rehabilitation
Telemedicine
Healthy Lifestyle
Preventive Programs
Artificial Intelligence
Predictive Medicine
Continuum of Care
Maintenance
Aftercare
eHealth
mHealth
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: European Commission
name: University of Amsterdam
name: Technische Universität Dresden
name: MEDIZINISCHE UNIVERSITAT GRAZ
name: Stichting Katholieke Universiteit
name: Foundation for Research and Technology - Hellas
First posted: 2022-07-18
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary Artery Disease (CAD) patients participating in phase II Cardiac Rehabilitation (CR).

Brief summary: 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:

1. To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes.
2. To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD.
3. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Cardiorespiratory Fitness (CRF)
timeFrame: Baseline, week 3, and week 24
measure: Change in risk of mortality
timeFrame: Baseline, week 3, and week 24
measure: Number of patients with major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: Baseline to week 48
Secondary outcomes:
measure: Physical activity (PA)
timeFrame: Baseline, week 3, week 24, and week 48
measure: Daily step count
timeFrame: Baseline to week 24
measure: Weekly number and duration of physical activities
timeFrame: Baseline to week 24
measure: Resting heart rate
timeFrame: Baseline to week 24
measure: Sleep duration
timeFrame: Baseline to week 24
measure: Physiological stress
timeFrame: Baseline to week 24
measure: Blood pressure
timeFrame: Baseline to week 24
measure: Arterial pressure wave propagation/reflection characteristics
timeFrame: Baseline to week 24
measure: Cardiac arrhythmia
timeFrame: Baseline to week 24
measure: Body composition
timeFrame: Baseline, week 3, and week 24
measure: Muscle strength
timeFrame: Baseline, week 3, and week 24
measure: Muscle function
timeFrame: Baseline, week 3, and week 24
measure: Submaximal exercise capacity
timeFrame: Baseline, week 3, and week 24
measure: Habit formation
timeFrame: Baseline, week 3, week 24, and week 48
measure: Nicotine dependence
timeFrame: Baseline, week 3, week 24, and week 48
measure: Cardiac Self-Efficacy
timeFrame: Baseline, week 3, week 24, and week 48
measure: Impact of disease
timeFrame: Baseline, week 3, week 24, and week 48
measure: General wellbeing
timeFrame: Baseline, week 3, week 24, and week 48
measure: Fear of Activity/ Kinesiophobia
timeFrame: Baseline, week 3, week 24, and week 48
measure: Depression
timeFrame: Baseline, week 3, week 24, and week 48
measure: General anxiety
timeFrame: Baseline, week 3, week 24, and week 48
measure: Health-related quality of life
timeFrame: Baseline, week 3, week 24, and week 48
measure: General quality of life
timeFrame: Baseline, week 3, week 24, and week 48
measure: Wellbeing
timeFrame: Baseline, week 3, week 24, and week 48
measure: Perceived stress
timeFrame: Baseline, week 3, week 24, and week 48
measure: Optimism/ Pessimism
timeFrame: Baseline, week 3, week 24, and week 48
measure: Conscientiousness
timeFrame: Baseline, week 3, week 24, and week 48
measure: Psychological flexibility
timeFrame: Baseline, week 3, week 24, and week 48
measure: Negative Affectivity
timeFrame: Baseline, week 3, week 24, and week 48
measure: Trait anger
timeFrame: Baseline, week 3, week 24, and week 48
measure: Religiousness/ spirituality
timeFrame: Baseline, week 3, week 24, and week 48
measure: Fatigue
timeFrame: Baseline, week 3, week 24, and week 48
measure: Psychological situation in the working environment
timeFrame: Baseline, week 3, week 24, and week 48
measure: Work requirements and workload
timeFrame: Baseline, week 3, week 24, and week 48
measure: Social support
timeFrame: Baseline, week 3, week 24, and week 48
measure: Relationship satisfaction
timeFrame: Baseline, week 3, week 24, and week 48
Other outcomes:
measure: Needs and requirements for eHealth in cardiac rehabilitation
timeFrame: Week 3
Locations:
city: Ennepetal
country: Germany
facility: Klinik Königsfeld
state: NRW
Study officials:
affiliation: University of Witten/Herdecke, Dpt. Rehabilitation Sciences
name: Boris Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: