Clinical trial NCT06759805: Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study
Official title: eCardiacRehab - a Pragmatic Trial on a Home-based Patient-centered e-Health Programme With Tailored Solutions - Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Helse Vest
name: Helse Fonna
name: Helse Møre og Romsdal HF
name: Helse Vest IKT
name: Western Norway University of Applied Sciences
name: Youwell
name: University of Bergen
name: Østfold University College
name: Norsk råd for digital etikk
name: Helse Førde HF
name: University of Amsterdam
name: Center for Research on Cardiac Disease in Women
name: Nasjonal kompetansetjeneste Trening som medisin
name: RELIS Vest
name: Norwegian Centre for E-health Research
name: Bergen Municipality
name: Sunnfjord Municipality
name: Sogndal Municipality
name: Masfjorden Municipality
name: The Norwegian Heart and Lung Patient Organization
name: E-helse Vestland
name: Yale University
name: University of Sydney
name: University of Cambridge
name: University of Regina
name: University of Copenhagen
name: Linkoeping University
name: Voss Hospital, Norway
First posted: 2025-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The participants' engagement and adherence to the intervention
timeFrame: From start to the end of the programme (12 weeks)
measure: Missing rate
timeFrame: From start to end of programme (12 weeks)
measure: Attrition rate
timeFrame: From start to the end of programme (12 weeks)
Secondary outcomes:
measure: Hospitalization
timeFrame: 180 days hospitalization
measure: Change in beliefs and perceptions about medicines and treatment
timeFrame: Up to 24 months.
measure: Continuity of care
timeFrame: Self-report up to 6 months.
measure: Change in health literacy
timeFrame: Up to 24 months
measure: Anxiety and depression
timeFrame: Up to 24 months
measure: Maximal oxygen consumption (Vo2 max)
timeFrame: Baseline and 12 weeks.
measure: Healthcare utilization
timeFrame: Up to 24 months.
measure: Healthcare cost
timeFrame: Up to 24 months.
measure: Change in health status following myocardial infarction
timeFrame: Up to 24 months.
measure: Change in fatigue
timeFrame: Up to 24 months
measure: Change in eHealth literacy
timeFrame: Up to 24 months
measure: Change in medication use
timeFrame: Up to 10 years
measure: Change in self-reported medication adherence
timeFrame: Up to 24 months
measure: Change in physical and mental dimensions of health
timeFrame: Up to 24 months
measure: Health related quality of life
timeFrame: Up to 24 months
measure: Change in chest pain
timeFrame: Up to 24 months
measure: Change in self-reported health
timeFrame: Up to 24 months
measure: Digital health readiness
timeFrame: Up to 24 months
measure: Change in insomnia
timeFrame: Up to 24 months
measure: Change in sleep
timeFrame: Up to 24 months
measure: Medication adherence assessed by therapeutic drug monitoring
timeFrame: Baseline, 3 and 6 months
measure: Blood samples
timeFrame: Baseline, 3 and 6 months.
measure: Change in blood pressure
timeFrame: Up to end of programme
measure: Change in biometrics
timeFrame: Baseline, start and end of programme
measure: Change in nicotine status
timeFrame: Up to 24 months
measure: Change in self-reported intensity-adjusted minutes
timeFrame: Up to 24 months
measure: Biosensor data
timeFrame: Throughout the 12-week program
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Tone M Norekvål, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.