Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

NCT ID: NCT06759805

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2035-10-30

Brief Summary

In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations 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 eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.

Conditions

Coronary Artery Disease; Cardiac Rehabilitation; Ethics; Continuity of Patient Care; Older Adults (65 Years and Older); Cost-Benefit Analysis; Adherence, Medication; Adherence, Treatment; Health Literacy; eHealth Literacy; Mental Health; Secondary Prevention of Coronary Heart Disease; Comorbidities; Hypertension; Physical Activity; Women

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Digital cardiac rehabilitation

Group Type: OTHER

eCardiacRehab

Intervention Type: OTHER

Interdisciplinary supervised home-based digital secondary prevention programme (12-week programme) based on the European Society of Cardiology guidelines for cardiac rehabilitation for patients after percutaneous coronary intervention.

Interventions

eCardiacRehab

Interdisciplinary supervised home-based digital secondary prevention programme (12-week programme) based on the European Society of Cardiology guidelines for cardiac rehabilitation for patients after percutaneous coronary intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number,
• With coronary artery disease after percutaneous coronary intervention
• Are living at home and have internet available to them
• Providing signed informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Helse Vest

OTHER

Sponsor Role: collaborator

Helse Fonna

OTHER

Sponsor Role: collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role: collaborator

Helse Vest IKT

UNKNOWN

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: collaborator

Youwell

UNKNOWN

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Østfold University College

UNKNOWN

Sponsor Role: collaborator

Norsk råd for digital etikk

UNKNOWN

Sponsor Role: collaborator

Helse Førde HF

UNKNOWN

Sponsor Role: collaborator

University of Amsterdam

OTHER

Sponsor Role: collaborator

Center for Research on Cardiac Disease in Women

UNKNOWN

Sponsor Role: collaborator

Nasjonal kompetansetjeneste Trening som medisin

UNKNOWN

Sponsor Role: collaborator

RELIS Vest

UNKNOWN

Sponsor Role: collaborator

Norwegian Centre for E-health Research

UNKNOWN

Sponsor Role: collaborator

Bergen Municipality

UNKNOWN

Sponsor Role: collaborator

Sunnfjord Municipality

UNKNOWN

Sponsor Role: collaborator

Sogndal Municipality

UNKNOWN

Sponsor Role: collaborator

Masfjorden Municipality

UNKNOWN

Sponsor Role: collaborator

The Norwegian Heart and Lung Patient Organization

UNKNOWN

Sponsor Role: collaborator

E-helse Vestland

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Voss Hospital, Norway

UNKNOWN

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tone M Norekvål, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Trond R Pettersen, PhD

Role: CONTACT

trond.roed.pettersen@helse-bergen.no

004748124938

Facility Contacts

Trond R Pettersen, PhD

Role: primary

trond.roed.pettersen@helse-bergen.no

004748124938

References

Brors G, Pettersen TR, Hansen TB, Fridlund B, Holvold LB, Lund H, Norekval TM. Modes of e-Health delivery in secondary prevention programmes for patients with coronary artery disease: a systematic review. BMC Health Serv Res. 2019 Jun 10;19(1):364. doi: 10.1186/s12913-019-4106-1.

Reference Type: BACKGROUND

PMID: 31182100 (View on PubMed)

Valaker I, Fridlund B, Wentzel-Larsen T, Nordrehaug JE, Rotevatn S, Raholm MB, Norekval TM. Continuity of care and its associations with self-reported health, clinical characteristics and follow-up services after percutaneous coronary intervention. BMC Health Serv Res. 2020 Jan 31;20(1):71. doi: 10.1186/s12913-020-4908-1.

Reference Type: BACKGROUND

PMID: 32005235 (View on PubMed)

Norekval TM, Allore HG, Bendz B, Bjorvatn C, Borregaard B, Brors G, Deaton C, Falun N, Hadjistavropoulos H, Hansen TB, Igland S, Larsen AI, Palm P, Pettersen TR, Rasmussen TB, Schjott J, Sogaard R, Valaker I, Zwisler AD, Rotevatn S; CONCARD Investigators. 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). BMJ Open. 2020 Feb 12;10(2):e031995. doi: 10.1136/bmjopen-2019-031995.

Reference Type: BACKGROUND

PMID: 32054625 (View on PubMed)

Norekval TM, Allore HG. Cardiac rehabilitation in older adults: is it just lifestyle? Heart. 2020 Jul;106(14):1035-1037. doi: 10.1136/heartjnl-2019-316497. Epub 2020 Apr 16. No abstract available.

Reference Type: BACKGROUND

PMID: 32299827 (View on PubMed)

Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Osborne RH, Palm P, Wentzel-Larsen T, Norekval TM; CONCARD investigators. Health Literacy and Risk Factors for Coronary Artery Disease (From the CONCARDPCI Study). Am J Cardiol. 2022 Sep 15;179:22-30. doi: 10.1016/j.amjcard.2022.06.016. Epub 2022 Jul 16.

Reference Type: BACKGROUND

PMID: 35853782 (View on PubMed)

Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Norman CD, Palm P, Wentzel-Larsen T, Norekval TM. 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. Eur Heart J Digit Health. 2023 Feb 7;4(2):125-135. doi: 10.1093/ehjdh/ztad010. eCollection 2023 Mar.

Reference Type: BACKGROUND

PMID: 36974270 (View on PubMed)

Instenes I, Fridlund B, Borregaard B, Larsen AI, Allore H, Bendz B, Deaton C, Rotevatn S, Falun N, Norekval TM. 'When age is not a barrier': an explorative study of nonagenarian patients' experiences of undergoing percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2024 Sep 5;23(6):608-617. doi: 10.1093/eurjcn/zvad132.

Reference Type: BACKGROUND

PMID: 38243638 (View on PubMed)

Hjertvikrem N, Brors G, Instenes I, Helmark C, Pettersen TR, Rotevatn S, Zwisler ADO, Norekval TM; CONCARDPCI Investigators. Use of health services and perceived need for information and follow-up after percutaneous coronary intervention. BMC Res Notes. 2024 Jan 5;17(1):20. doi: 10.1186/s13104-023-06662-y.

Reference Type: BACKGROUND

PMID: 38183067 (View on PubMed)

Ferrel-Yui D, Candelaria D, Pettersen TR, Gallagher R, Shi W. Uptake and implementation of cardiac telerehabilitation: A systematic review of provider and system barriers and enablers. Int J Med Inform. 2024 Apr;184:105346. doi: 10.1016/j.ijmedinf.2024.105346. Epub 2024 Jan 24.

Reference Type: BACKGROUND

PMID: 38281451 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37943676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38238118 (View on PubMed)

Related Links

https://www.helse-bergen.no/avdelinger/hjarteavdelinga/procard/ehjerterehab

eCardiacRehab study page

Other Identifiers

344337

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F-12624

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R-10930

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

459136

Identifier Type: -

Identifier Source: org_study_id