Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

NCT06759805 | Recruiting DMC

• 4 other identifiers: 459136344337F-12624R-10930
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The participants' engagement and adherence to the intervention

  Based on previous studies, the success criteria will be one login to the website on average once per week, and that 50% of participants will watch some or all the video messages on the website. Usage will be assessed as time spent using the programme, number of logins with start and end time, summary of number of sessions, messages sent, modules completed, and registrations per patient, number of completed questionnaires per patient, and start and end time for all modules in the programme. This will be assessed based on website usage statistics gathered by a website visit tracking system. Further, participants will be asked to report login-errors.

  From start to the end of the programme (12 weeks)

• Missing rate

  Acceptability of the secondary and primary outcomes is assessed through response and completion rates. The proportion of missing data in each completed questionnaire at baseline and at the end of the intervention of less than 20% is acceptable.

  From start to end of programme (12 weeks)

• Attrition rate

  A success criterion to reduce the threats to validity is an attrition rate of no more than 20%. When possible, the reasons for participants leaving the study are obtained and reported in a study log.

  From start to the end of programme (12 weeks)

Secondary Outcomes (27)

• Hospitalization

  180 days hospitalization

• Change in beliefs and perceptions about medicines and treatment

  Up to 24 months.

• Continuity of care

  Self-report up to 6 months.

• Change in health literacy

  Up to 24 months

• Anxiety and depression

  Up to 24 months

Study Arms (2)

Control group

NO INTERVENTION

Usual care

Intervention group

OTHER

Digital cardiac rehabilitation

Other: eCardiacRehab

Interventions

eCardiacRehab 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.

Intervention group

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
• Are living at home and have internet available to them
• Providing 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 Patient Organization: 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 Hospital, Norway: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

RECRUITING

Related Publications (11)

• 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.

  PMID: 31182100 BACKGROUND

• 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.

  PMID: 32005235 BACKGROUND

• 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.

  PMID: 32054625 BACKGROUND

• 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.

  PMID: 32299827 BACKGROUND

• 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.

  PMID: 35853782 BACKGROUND

• 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.

  PMID: 36974270 BACKGROUND

• 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.

  PMID: 38243638 BACKGROUND

• 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.

  PMID: 38183067 BACKGROUND

• 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.

  PMID: 38281451 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

• 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

Related Links

• eCardiacRehab study page

MeSH Terms

Conditions

Coronary Artery Disease; Medication Adherence; Treatment Adherence and Compliance; Psychological Well-Being; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Tone M Norekvål, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trond R Pettersen, PhD

CONTACT

004748124938; trond.roed.pettersen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 6, 2025
• Study Start: January 6, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2035
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)