eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaukeland University Hospital

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

Qualifiers

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

Treatments tested in this trial

  • eCardiacRehab

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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