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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • eCardiacRehab

    Other intervention

    12-week digital cardiac rehabilitation

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: eCardiacRehabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.

Secondary outcomes

1

Cardiovascular mortality

Time to cardiovascular cause death from randomization.

Time frame
1, 3, 5 years
2

Cardiovascular Emergency Department contact

Time to Cardiovascular (CV) Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (\>24 hours)

Time frame
1, 3, 5 years
3

All-cause mortality

Time to all-cause death from randomization

Time frame
1, 3, 5 years
4

All-cause Emergency Department contact

Emergency Department (ED) contact and home, ED and observation, ED and admission (\>24 hours)

Time frame
1, 3, 5 years

Other outcomes

1

Biomarkers

Blood: Cardiac and inflammation markers. Urine: amino acid metabolites, organic acids and intermediates of fatty acid oxidation.

Time frame
Baseline and end of the 12-week programme
2

Blood pressure

Time frame
Baseline, start and end of the 12-week programme
3

Total number of ED contacts

Time frame
Up to 10 years
4

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

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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