eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

NCT07590635 | Not Yet Recruiting DMC

• 1 other identifier: F-12624
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

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; Womens's Health; Coronary Artery Disease (CAD); Comorbidities and Coexisting Conditions; Cardiac Rehabilitation; Mental Health

Keywords

Cardiac Rehabilitation; Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

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.

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

Secondary Outcomes (28)

• Cardiovascular mortality

  1, 3, 5 years

• Cardiovascular Emergency Department contact

  1, 3, 5 years

• All-cause mortality

  1, 3, 5 years

• All-cause Emergency Department contact

  1, 3, 5 years

• The Myocardial Infarction Dimensional Assessment Scale (MIDAS)

  Pre-intervention, immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.

Other Outcomes (4)

• Biomarkers

  Baseline and end of the 12-week programme

• Blood pressure

  Baseline, start and end of the 12-week programme

• Total number of ED contacts

  Up to 10 years

Study Arms (2)

Usual care

NO INTERVENTION

No intervention

eCardiacRehab

ACTIVE COMPARATOR

Digital cardiac rehabilitation

Other: eCardiacRehab

Interventions

eCardiacRehab OTHER

12-week digital cardiac rehabilitation

eCardiacRehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Provide signed informed consent

You may not qualify if:

• 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
• Otherwise clinically unstable
• Not fully revascularized
• Awaits percutaneous coronary intervention or coronary artery bypass graft surgery
• Inability to comply with the study protocol due to any physical disability, somatic disease, or mental problems as determined by study personnel

Sponsors & Collaborators

• Haukeland University Hospital: lead
• 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

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (2)

• Pettersen TR, Schjott J, Allore H, Bendz B, Borregaard B, Fridlund B, Hadjistavropoulos HD, Larsen AI, Nordrehaug JE, Rasmussen TB, Rotevatn S, Valaker I, Wentzel-Larsen T, Norekval TM; CONCARD Investigators. Discharge Information About Adverse Drug Reactions Indicates Lower Self-Reported Adverse Drug Reactions and Fewer Concerns in Patients After Percutaneous Coronary Intervention. Heart Lung Circ. 2024 Mar;33(3):350-361. doi: 10.1016/j.hlc.2023.12.005. Epub 2024 Jan 18.

  PMID: 38238118 BACKGROUND

• Norekval TM, Bale M, Bedane HK, Hole T, Ingul CB, Munkhaugen J. Cardiac rehabilitation participation within 6 months of discharge in 37 136 myocardial infarction survivors: a nationwide registry study. Eur J Prev Cardiol. 2024 Nov 18;31(16):1977-1980. doi: 10.1093/eurjpc/zwad350. No abstract available.

  PMID: 37943676 BACKGROUND

Related Links

• Study website

MeSH Terms

Conditions

Medication Adherence; Psychological Well-Being; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Personal Satisfaction; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tone M Norekvål, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trond R Pettersen, PhD

CONTACT

+4748124938; trond.roed.pettersen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Analysts: Researchers responsible for analyzing the data are blinded to group assignments to prevent bias in data interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 15, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2037
• Last Updated: May 15, 2026

Record last verified: 2026-04

Locations

NO (1)