eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

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.

NCT Number	NCT07590635
Lead Sponsor	Haukeland University Hospital Collaborators: The Research Council of Norway, Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Helse Vest IKT, Western Norway University of Applied Sciences, Youwell, University of Bergen, Østfold University College, Norsk råd for digital etikk, Helse Førde HF, University of Amsterdam, Center for Research on Cardiac Disease in Women, Nasjonal kompetansetjeneste Trening som medisin, RELIS Vest, Norwegian Centre for E-health Research, Bergen Municipality, Sunnfjord Municipality, Sogndal Municipality, Masfjorden Municipality, The Norwegian Heart and Lung Patients Association (LHL), E-helse Vestland, Yale University, University of Sydney, University of Cambridge, University of Regina, University of Copenhagen, Linkoeping University, Voss Sykehus
Conditions	Comorbidities and Coexisting Conditions, Ethics, Continuity of Patient Care, Older Adults (65 Years and Older), Cost-Benefit Analysis, Adherence, Medication, Secondary Prevention of Coronary Heart Disease, Health Literacy +5 more
Enrollment	1,000 participants
Start Date	2026-05-21
Primary Completion	2027-12-31 (estimated)
Study Completion	2037-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-23