Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06759805

eCardiacRehab - a Pragmatic Trial on a Home-based Patient-centered e-Health Programme With Tailored Solutions - Feasibility Study

Led by Haukeland University Hospital · Updated on 2025-03-13

80

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

H

Haukeland University Hospital

Lead Sponsor

T

The Research Council of Norway

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a home-based digital cardiac rehabilitation program called eCardiacRehab for patients with coronary artery disease after percutaneous coronary intervention (PCI). This study aims to improve access to rehabilitation services, especially for older adults, women, and those with other health issues or mental health challenges. The program addresses gaps in traditional rehabilitation uptake, which is low despite known benefits on readmissions, physical fitness, psychological well-being, self-management, and quality of life. It also investigates factors like health literacy, treatment adherence, cost effectiveness, and continuity of care between specialists and primary healthcare. The eCardiacRehab is a 12-week interdisciplinary home-based digital program based on European Society of Cardiology guidelines for cardiac rehabilitation. Participants will either receive usual care or the digital rehabilitation intervention. The study involves developing treatment modules, communication infrastructure, and tailored solutions to improve rehabilitation access and coordination between healthcare services. The program is designed to be patient-centered and includes collaboration with patients, healthcare providers, and technology developers. Participants will be involved for 12 weeks during the intervention, with assessments of their engagement, adherence, and retention in the program. Researchers will collect various data including blood samples, biosensor information, physical and mental health measures, medication adherence, hospitalizations, and health literacy over periods up to 24 months or longer. Safety and health outcomes will be monitored, and the study also evaluates cost effectiveness and changes in health status, fatigue, anxiety, depression, and quality of life. Overall participation duration and follow-up extend up to 10 years for certain measures.

CONDITIONS

Brief Title

Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult Norwegian (or Scandinavian) speaking patients aged 18 years or older with a Norwegian national identification number
  • Diagnosed with coronary artery disease after percutaneous coronary intervention
  • Living at home with internet access
  • Providing signed informed consent
Not Eligible

You will not qualify if you...

  • Cognitive impairment that may interfere with compliance with the study protocol
  • Severe aortic stenosis
  • Severe arrhythmias
  • Expected lifetime less than one year as determined by study personnel
  • Clinically unstable condition
  • Not fully revascularized (awaiting percutaneous coronary intervention or coronary artery bypass graft surgery)
  • Inability to comply with the study protocol due to physical disability, somatic disease, or mental problems as determined by study personnel

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants engage in a 12-week home-based digital cardiac rehabilitation programme tailored to support recovery after percutaneous coronary intervention.

Ongoing remote participation with biosensor data collection throughout the 12-week programme

Follow-up

Duration - Up to 24 months

Participants are monitored for health outcomes and adherence up to 24 months after the programme, including medication adherence and health status assessments.

Assessments at baseline, 3 months, 6 months, and periodic self-reports up to 24 months

Trial Site Locations

Total: 1 location

1

Haukeland University Hospital

Bergen, Norway

Actively Recruiting

Loading map...

Research Team

T

Trond R Pettersen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

"Smart Family Doctor" Assisted Comprehensive Management of S...

Post Coronary Artery Bypass Grafting

Actively Recruiting

1 location

We Are an Active Family: Promoting Child Physical Activity T...

Physical Activity

Actively Recruiting

2 locations

The PILI 'Aina Project to Improve Cardiometabolic Health in...

Type 2 Diabetes

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Modes of e-Health delivery in secondary prevention programmes for patients with coronary artery disease: a systematic review.

Gunhild Brørs, Trond Røed Pettersen, Tina B Hansen...

https://pubmed.ncbi.nlm.nih.gov/31182100

Continuity of care and its associations with self-reported health, clinical characteristics and follow-up services after percutaneous coronary intervention.

Irene Valaker, Bengt Fridlund, Tore Wentzel-Larsen...

https://pubmed.ncbi.nlm.nih.gov/32005235

Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI).

Tone M Norekvål, Heather G Allore, Bjørn Bendz...

https://pubmed.ncbi.nlm.nih.gov/32054625

The association of electronic health literacy with behavioural and psychological coronary artery disease risk factors in patients after percutaneous coronary intervention: a 12-month follow-up study.

Gunhild Brørs, Håvard Dalen, Heather Allore...

https://pubmed.ncbi.nlm.nih.gov/36974270

'When age is not a barrier': an explorative study of nonagenarian patients' experiences of undergoing percutaneous coronary intervention.

Irene Instenes, Bengt Fridlund, Britt Borregaard...

https://pubmed.ncbi.nlm.nih.gov/38243638

Use of health services and perceived need for information and follow-up after percutaneous coronary intervention.

Nina Hjertvikrem, Gunhild Brørs, Irene Instenes...

https://pubmed.ncbi.nlm.nih.gov/38183067

Uptake and implementation of cardiac telerehabilitation: A systematic review of provider and system barriers and enablers.

Daniel Ferrel-Yui, Dion Candelaria, Trond Røed Pettersen...

https://pubmed.ncbi.nlm.nih.gov/38281451

Cardiac rehabilitation participation within 6 months of discharge in 37 136 myocardial infarction survivors: a nationwide registry study.

Tone M Norekvål, Marte Bale, Haji Kedir Bedane...

https://pubmed.ncbi.nlm.nih.gov/37943676