eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

Summary

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.

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
• eHealth Literacy
• Mental Health
• Cardiac Rehabilitation
• Womens's Health
• Coronary Artery Disease (CAD)

Interventions

OTHER

eCardiacRehab

12-week digital cardiac rehabilitation

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Helse Vest

  collaborator OTHER

• Helse Fonna

  collaborator OTHER

• Helse Møre og Romsdal HF

  collaborator OTHER_GOV

• Helse Vest IKT

  collaborator UNKNOWN

• Western Norway University of Applied Sciences

  collaborator OTHER

• Youwell

  collaborator UNKNOWN

• University of Bergen

  collaborator OTHER

• Østfold University College

  collaborator UNKNOWN

• Norsk råd for digital etikk

  collaborator UNKNOWN

• Helse Førde HF

  collaborator UNKNOWN

• University of Amsterdam

  collaborator OTHER

• Center for Research on Cardiac Disease in Women

  collaborator UNKNOWN

• Nasjonal kompetansetjeneste Trening som medisin

  collaborator UNKNOWN

• RELIS Vest

  collaborator UNKNOWN

• Norwegian Centre for E-health Research

  collaborator UNKNOWN

• Bergen Municipality

  collaborator UNKNOWN

• Sunnfjord Municipality

  collaborator UNKNOWN

• Sogndal Municipality

  collaborator UNKNOWN

• Masfjorden Municipality

  collaborator UNKNOWN

• The Norwegian Heart and Lung Patients Association (LHL)

  collaborator UNKNOWN

• E-helse Vestland

  collaborator UNKNOWN

• Yale University

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University of Regina

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Voss Sykehus

  collaborator UNKNOWN

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Tone M Norekvål, PhD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-04

Primary Completion

2027-12-31

Completion

2037-12-31

Countries

• Norway

Study Locations