About this trial
The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all.
eCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (\>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number
With coronary artery disease after percutaneous coronary intervention
Living at home
Have internet available
Disqualifiers
Patients with cognitive impairment that may interfere with the ability to comply with the study protocol
Severe aortic stenosis
Severe arrhythmias
Expected lifetime less than one year as determined by study personnel
Trial design
Parallel
Treatments tested in this trial
eCardiacRehab
Other intervention12-week digital cardiac rehabilitation
Treatment groups
Trial outcomes
Primary outcomes
Composite clinical hierarchy of outcomes
Composite clinical hierarchy of outcomes: Cardiovascular (CV) Death, CV Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (\>24 hours), and quality of life.
Secondary outcomes
Cardiovascular mortality
Time to cardiovascular cause death from randomization.
Cardiovascular Emergency Department contact
Time to Cardiovascular (CV) Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (\>24 hours)
All-cause mortality
Time to all-cause death from randomization
All-cause Emergency Department contact
Emergency Department (ED) contact and home, ED and observation, ED and admission (\>24 hours)
Other outcomes
Biomarkers
Blood: Cardiac and inflammation markers. Urine: amino acid metabolites, organic acids and intermediates of fatty acid oxidation.
Blood pressure
Total number of ED contacts
Cognition
The 4AT is a 0-12 point delirium screening tool. Score 4 or more suggests delirium; 1-3 suggests cognitive impairment; 0 suggests no delirium/severe impairment
Sponsors and contacts
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Haukeland University Hospital
Lead sponsor
The Research Council of Norway
Collaborator
Helse Vest
Collaborator
Helse Fonna
Collaborator
Helse Møre og Romsdal HF
Collaborator
Helse Vest IKT
Collaborator
Western Norway University of Applied Sciences
Collaborator
Youwell
Collaborator
University of Bergen
Collaborator
Østfold University College
Collaborator
Norsk råd for digital etikk
Collaborator
Helse Førde HF
Collaborator
University of Amsterdam
Collaborator
Center for Research on Cardiac Disease in Women
Collaborator
Nasjonal kompetansetjeneste Trening som medisin
Collaborator
RELIS Vest
Collaborator
Norwegian Centre for E-health Research
Collaborator
Bergen Municipality
Collaborator
Sunnfjord Municipality
Collaborator
Sogndal Municipality
Collaborator
Masfjorden Municipality
Collaborator
The Norwegian Heart and Lung Patients Association (LHL)
Collaborator
E-helse Vestland
Collaborator
Yale University
Collaborator
University of Sydney
Collaborator
University of Cambridge
Collaborator
University of Regina
Collaborator
University of Copenhagen
Collaborator
Linkoeping University
Collaborator
Voss Sykehus
Collaborator