RecruitingNot ApplicableNCT07590635

eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

eCardiacRehab - a Randomized Controlled Trial on a Hybrid Home-Based Patient-Centered eHealth Programme With Tailored Solutions


Sponsor

Haukeland University Hospital

Enrollment

1,000 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria8

  • 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

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Interventions

OTHEReCardiacRehab

12-week digital cardiac rehabilitation


Locations(1)

Haukeland University Hospital

Bergen, Norway

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NCT07590635


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