Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study (eCardiacRehab)

ECardiacRehab - a Pragmatic Trial on a Home-based Patient-centered E-Health Programme with Tailored Solutions - Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Hypertension; Physical Activity; Adherence, Medication; Mental Health; Cardiac Rehabilitation; Comorbidities; Cost-Benefit Analysis; Adherence, Treatment; Health Literacy; Continuity of Patient Care; Women; Ethics; Secondary Prevention of Coronary Heart Disease; Older Adults (65 Years and Older); EHealth Literacy
• Intervention / Treatment: Other: eCardiacRehab

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trond R Pettersen, PhD; Phone Number: 004748124938; Email: trond.roed.pettersen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Trond R Pettersen, PhD; Phone Number: 004748124938; Email: trond.roed.pettersen@helse-bergen.no
    • Contact: Tone M Norekvål, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care
Other: Intervention group; Digital cardiac rehabilitation	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Composite end-point of Emergency Department (ED) contact and home, ED and observation, ED and admission (>24 hours), and death, whichever comes first.	180 days hospitalization
Change in beliefs and perceptions about medicines and treatment	The Beliefs about Medicines Questionnaire (BMQ) assesses beliefs and perceptions about medicines and treatment. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. The two sections of the BMQ can be used in combination or separately. For this study, the BMQ-Specific will be used. Respondents rate 11 items on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).	Up to 24 months.
Continuity of care	The Heart Continuity of Care Questionnaire (HCCQ) comprises 33 items covering eight topic areas regarding continuity of care. Respondents rate each item on a 6-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) or 6 (not applicable).	Self-report up to 6 months.
Change in health literacy	The Health literacy questionnaire (HLQ) has nine scale scores that each measure an aspect of the multidimensional construct of health literacy. Each score provides insight into the strengths and limitations of the respondent, but the scores are most powerful when viewed together to show the 'health literacy profile' of the respondent	Up to 24 months
Anxiety and depression	The Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).	Up to 24 months
Maximal oxygen consumption (Vo2 max)	Maximal oxygen consumption (VO2max) as measured by cardiopulmonary exercise testing (CPET).	Baseline and 12 weeks.
Healthcare utilization	Healthcare utilization will be assessed during follow-up, including patients' use of primary care services (general practitioner visits) and secondary care services (inpatient admissions and outpatient visits). The data source will be nationwide registries. The measurement unit will be mean number of visits.	Up to 24 months.
Healthcare cost	Health care (associated) costs will be valued using the tariffs of national agreements between the professional associations of medical specialists and the National Health Services. In secondary care, inpatient admissions and outpatient visits will be valued using the tariffs of the national case-mix system of the diagnosis-related groupings (DRG) and the ambulatory grouping system (DAGS). In addition, data will be collected on prescription of medication, which will be valued using the retail price. The data source will be nationwide registries. The measurement unit will be mean costs in Euros.	Up to 24 months.
Change in health status following myocardial infarction	The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.	Up to 24 months.
Change in fatigue	A visual analog scale ranging from 0 (fatigue is not a problem) to 10 (fatigue is a major problem) is used to measure change in fatigue.	Up to 24 months
Change in eHealth literacy	The eHealth Literacy Scale (Eheals) is an 8-item measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. Respondents indicate their agreement with statements on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly agree).	Up to 24 months
Change in medication use	Data related to consumption of prescribed medication are identified through national prescription registries. The registries cover all prescriptions dispensed at pharmacies nationwide. The registries also include information about date of dispensation, quantity and strength dispensed. This will serve as complimentary information to patients' self-reported adherence.	Up to 10 years
Change in self-reported medication adherence	The my experience of taking medicines (MYMEDS) questionnaire consists of six sections. Section 1: essential contextual information (e.g. the medicines taken). Section 2: overall understanding and satisfaction with medicines (four-point Likert scale (strongly agree, agree, disagree, strongly disagree)). Section 3: areas of anxiety about medicines (e.g. worry that they will cause more harm than good). Section 4: four separate practical concerns associated with medicines taking (e.g. swallowing problems). Section 5: assesses three issues in fitting medicines into patients' daily routine (e.g. relating to forgetfulness or inconvenience). Section 6: asks about adherence to each individual medicine over the past month (five point Likert scale). .	Up to 24 months
Change in physical and mental dimensions of health	RAND-12 measures physical and mental dimensions of health. The 12 items in the questionnaire correspond to eight principal physical and mental health domains. The 12 items are summarized into two scores, a "Physical Health Summary Measure (PCS-physical component score)" and a "Mental Health Summary Measure (MCS-mental component score)".	Up to 24 months
Health related quality of life	The HeartQoL questionnaire is a core ischemic heart disease specific health related quality of life (HRQL) questionnaire. The questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if needed.	Up to 24 months
Change in chest pain	The Seattle Angina Questionnaire (SAQ-7) comprises 7 dimensions of coronary artery disease. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).	Up to 24 months
Change in self-reported health	EQ-5D-5L is an 5 item (plus a VAS scale) self-report-questionnaire assessing self-reported health. Each question has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Up to 24 months
Digital health readiness	Responses to the Digital Health Readiness Questionnaire (DHRQ) are scored on a 5-point Likert scale (strongly disagree to strongly agree). The sum of the first 4 domains gives the total score on the DHRQ. The minimum score of the DHRQ is 15, and the maximum score of the DHRQ is 75. Additionally, a fifth domain called digital learnability is assessed.	Up to 24 months
Change in insomnia	The Minimal Insomnia Symptom Scale (MISS) comprises 3 items assessing major features of insomnia, i.e. difficulties initiating sleep, waking at night and not feeling refreshed by sleep.	Up to 24 months
Change in sleep	The Sleep Sufficient Index (SSI) comprises 2 items assessing amount of actual and desired sleep.	Up to 24 months
Medication adherence assessed by therapeutic drug monitoring	Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry)	Baseline, 3 and 6 months
Blood samples	HbA1c (≤7.0%), lipids, cardiac and inflammation markers(e.g. troponins, natriuretic peptides and CRP).	Baseline, 3 and 6 months.
Change in blood pressure	Blood pressure targets (<120/70 mmHg at nurse visit; <120/70 mmHg at home measurement)	Up to end of programme
Change in biometrics	BMI (WHO- classification), visceral fat, muscle mass, body fat.	Baseline, start and end of programme
Change in nicotine status	Self-reported change in nicotine status	Up to 24 months
Change in self-reported intensity-adjusted minutes	The the physical activity frequency, intensity, and duration (PAFID) questionnaire contains three items on physical activity: (i) frequency [never (0), less than once per week (0.5), once per week (1), 2-3 times per week (2.5), or almost every day (5)]; (ii) duration of each exercise session [<15 min (7.5), 15-29 min (22.5), 30-60 min (45), or over 60 min (75)]; and (iii) intensity [low ('I take it easy, I don't get out of breath or break a sweat'), moderate ('I push myself until I'm out of breath or break into a sweat'), or high ('I practically exhaust myself')]. The number of minutes of physical activity is calculated as the average time spent per session multiplied by the average frequency of exercise per week multiplied by the weighted intensity [low (0.5), moderate (1), and high (2)] based on the values in brackets.	Up to 24 months
Biosensor data	Biosensor data is collected throughout the 12-week program, and include time spent sedentary and in light-, moderate- and vigorous-intensity physical activity, daily step count, resting/maximal heart rate, sleep time and quality and time and duration of wearing the wearable device.	Throughout the 12-week program

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Yale University; University of Copenhagen; University of Bergen; The Research Council of Norway; Linkoeping University; University of Amsterdam; University of Sydney; University of Cambridge; Helse Fonna; Helse Vest; Western Norway University of Applied Sciences; Helse Møre og Romsdal HF; University of Regina; The Norwegian Heart and Lung Patient Organization; Østfold University College; Bergen Municipality; Helse Førde HF; Helse Vest IKT; Youwell; Norsk råd for digital etikk; Center for Research on Cardiac Disease in Women; Nasjonal kompetansetjeneste Trening som medisin; RELIS Vest; Norwegian Centre for E-health Research; Sunnfjord Municipality; Sogndal Municipality; Masfjorden Municipality; E-helse Vestland; Voss Hospital, Norway
• Investigators: Principal Investigator: Tone M Norekvål, PhD, Haukeland University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Eur Heart J Digit Health. 2023 Oct 31;4(6):500. doi: 10.1093/ehjdh/ztad061. Eur Heart J Digit Health. 2024 Jun 13;5(4):502. doi: 10.1093/ehjdh/ztae044.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• eCardiacRehab study page

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2035

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 459136; 344337 (Other Grant/Funding Number: Norwegian Research Council); F-12624 (Western Norway Regional Health Authority); R-10930 (Other Grant/Funding Number: Western Norway Regional Health Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are not made available for others according to the Norwegian data protection legislation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No