eCardiacRehab - a Hybrid Patient-Centered eHealth Programme (eCardiacRehab)

eCardiacRehab - a Randomized Controlled Trial on a Hybrid Home-Based Patient-Centered eHealth Programme With Tailored Solutions

The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) 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 hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all.

eCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.

Study Overview

• Status: Not yet recruiting
• Conditions: Adherence, Medication; Mental Health; Cardiac Rehabilitation; Coronary Artery Disease (CAD); Cost-Benefit Analysis; Health Literacy; Continuity of Patient Care; Comorbidities and Coexisting Conditions; Ethics; Womens's Health; Secondary Prevention of Coronary Heart Disease; Older Adults (65 Years and Older); eHealth Literacy
• Intervention / Treatment: Other: eCardiacRehab

Detailed Description

The primary objective is to test whether a hybrid CR programme (the eCardiacRehab) reduces the risk of CV death and CV related ED contacts, and improves quality of life compared to usual care in patients with CAD treated with PCI.

The secondary and exploratory objectives (planned for the main study) are:

• To assess whether eCardiacRehab improves each of the components of the primary endpoint separately compared to usual care.
• To assess clinical outcomes associated with eCardiacRehab in the following subgroups: age, sex (men vs. women), hypertension (yes vs. no), multimorbidity (yes vs. no), mental health challenges (yes vs. no).
• To study whether eCardiacRehab reduces the total number of ED contacts compared to usual care.
• To study whether eCardiacRehab reduces the risk of all-cause death compared to usual care.
• To assess whether eCardiacRehab improves long-term medication adherence to cardiometabolic medications (e.g. antiplatelets, lipid lowering drugs, antihypertensive, and antidiabetics) in patients after PCI utilizing data from the Norwegian Prescribed Drug Registry, and by patients' self-report.
• To assess whether participation in eCardiacRehab improves the total number of CV risk factors.
• To assess whether participation in eCardiacRehab is non-inferior to conventional, in-person CR among the subset of usual care participants who attend standard place-based CR.

Other secondary objectives (for eCardiacRehab sub-studies) are:

• To conduct a cost-utility study, from a societal and healthcare system perspective perspective; cost per QALY. Cost categories include i) the intervention; ii) inpatient/outpatient visits; iii) community-based healthcare; iv) medications; v) patient-borne costs and vi) production loss due to sick leave. Further, to estimate cost-effectiveness acceptability curves to estimate the probability that the intervention is cost-effective at different willingness to pay for a unit of the outcome measure.
• To study whether eCardiacRehab affects the following patient-reported outcomes: quality of life, angina, anxiety, depression, sleep status, health literacy and eHealth literacy, frailty status, fatigue, continuity of care, and adherence to healthy lifestyle recommendations (physical activity, tobacco use, sleep, diet).
• To study whether eCardiacRehab improves objectively measured cardiorespiratory fitness (VO2peak), intensity minutes (activity tracker) and self-reported physical activity and exercise.
• To study whether eCardiacRehab improves body composition (visceral fat, muscle mass, body fat, BMI).
• To study whether eCardiacRehab improves change in number of controlled risk factors.
• To study whether eCardiacRehab improves low-density lipoproteins.

Exploratory objectives (for substudies):

• To evaluate whether eCardiacRehab improves long-term medication adherence to cardiometabolic medications (e.g. antiplatelets, lipid lowering drugs, antihypertensive, and antidiabetics) in patients after PCI utilizing data from therapeutic drug monitoring (assessed by direct methods quantifying drug concentrations in blood).
• To study differences in blood and urine biomarker concentrations between patients in the intervention and usual care group.
• To study changes in blood pressure associated with digital cardiac rehabilitation.
• To study cardiovascular mortality up to 10 years after index hospitalization.
• To study cardiovascular ED contact up to 10 years after index hospitalization.
• To study all-cause mortality up to 10 years after index hospitalization.
• To study all-cause ED contact up to 10 years after index hospitalization.
• To study the total number of ED contacts up to 10 years after index hospitalization.

Primary and secondary endpoints will be obtained by collection of self-reported data, clinical examination including blood and urine sample collection, and linkage to the following national registries: The Norwegian Registry of Invasive Cardiology, the Norwegian Population Registry, the Cause of Death Registry, the Norwegian Patient Registry, the Norwegian Myocardial Infarction Register, the Norwegian Prescription Database, the Norwegian Labour and Welfare Administration, Statistics Norway, the FD-Trygd database (social security micro data for research), the Control and payment of reimbursements to health service providers (KUHR) database and local hospital registries.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trond R Pettersen, PhD; Phone Number: +4748124938; Email: trond.roed.pettersen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
    • Contact: Trond R Pettersen, PhD; Phone Number: +4748124938; Email: trond.roed.pettersen@helse-bergen.no

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
• Living at home
• Have internet available
• Provide 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; No intervention
Active Comparator: eCardiacRehab; Digital cardiac rehabilitation	Other: eCardiacRehab; 12-week digital cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite clinical hierarchy of outcomes	Composite clinical hierarchy of outcomes: Cardiovascular (CV) Death, CV Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (>24 hours), and quality of life.	Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	Time to cardiovascular cause death from randomization.	1, 3, 5 years
Cardiovascular Emergency Department contact	Time to Cardiovascular (CV) Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (>24 hours)	1, 3, 5 years
All-cause mortality	Time to all-cause death from randomization	1, 3, 5 years
All-cause Emergency Department contact	Emergency Department (ED) contact and home, ED and observation, ED and admission (>24 hours)	1, 3, 5 years
The Myocardial Infarction Dimensional Assessment Scale (MIDAS)	Comprises 35 items specifically measuring seven different domains of health status and daily life challenges in individuals who have suffered a myocardial infarction: physical activity (12 items), insecurity (9 items), emotional reaction (4 items), dependency (3 items), diet (3 items), concerns over medication (2 items) and side effects (2 items). 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.	Pre-intervention, immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Seattle Angina Questionnaire (SAQ- 7)	SAQ-7 assesses patients' symptoms of chest pain, functioning, and quality of life through. The SAQ-7 is scored by transforming responses to seven items into three domains-Physical Limitation (PL), Angina Frequency (AF), and Quality of Life (QoL)-scaled from 0-100, where higher scores indicate better health. Items are coded 1-6 (worst to best), summed, and transformed. A total summary score is the average of these three domains	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, and 12-month follow-up.
RAND-12	Comprises 12 items with 3 to 5 response levels. It generates two health indices: mental and physical health. A score of 50 represents the average US population, while scores above or below indicate better or worse health, respectively.	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
WHOQOL-BREF	Comprises one global item on overall quality of life scored on a 1-5 Likert scale, ranging from "Very poor/dissatisfied" (1) to "Very good/satisfied" (5)	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The my experience of taking medicines (MYMEDS) questionnaire	Comprises 16 items and is a self-reporting tool for identifying modifiable adherence barriers among individuals prescribed post-myocardial infarction secondary prevention medicines in clinical practice. The questionnaire uses a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree) for sections 2-5, which focus on understanding, concerns, practical barriers, and routine. Adherence Assessment (Section 6): A 5-point Likert scale is used to assess adherence to individual secondary prevention medicines over the past month (e.g., all of the time, nearly all of the time, most of the time, about half the time, less than half the time).	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Therapeutic drug monitoring	Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry).	Maximum 1 year
EQ-5D-5L	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.	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Smoking status	Smoking status (smoker, previous smoker, never smoker)	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Hospital Anxiety and Depression Scale (HADS)	Comprises 14 items and determine the levels of anxiety and depression that a patient is experiencing, and generates 2 sub-scales; HADS-D and HADS-A. HADS-Anxiety and/or HADS-depression score ≥/< 8	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Heart Continuity of Care Questionnaire (HCCQ-16)	Comprises 16 items covering eight topic areas: heart condition explained, communication among providers, preparation for discharge, post-hospital review of treatment, receipt of conflicting information, information on medications and on physical and dietary needs. Respondents rate each item on a 6-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) or 6 (not applicable).	Pre-intervention, Immediately after the intervention, 6-month follow-up.
Health Literacy Questionnaire (HLQ)	Comprises 20 items measuring four levels of health literacy: Appraisal of health information (5 items); social support for health (5 items); Ability to find good information (5 items); and Understanding health information (5 items). 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.	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The eHealth Literacy Scale	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).	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Sleep Sufficient Index (SSI)	The Sleep Sufficiency Index (SSI) is calculated by dividing an individual's actual habitual sleep duration by their estimated needed sleep duration. It measures whether a person is getting enough sleep to feel rested, based on their personal requirements rather than a set number of hours. SSI >0.8: Classified as having sufficient sleep, provided the total duration is also > 6 hours. SSI < 0.8: Classified as having insufficient sleep, even if total sleep time is relatively high.	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Minimal Insomnia Symptom Scale (MISS)	The Minimal Insomnia Symptom Scale (MISS) is scored by summing the responses to three items covering difficulty falling asleep, staying asleep, and waking too early. Each item is rated on a 5-point scale (0-4), resulting in a total score from 0 to 12. A score of ≥6 is generally used as the cut-off to identify clinical insomnia in adults.	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Exercise	VO2peak, Self-reported intensity adjusted minutes, activity monitoring	VO2peak: start and end of the 12-week programme. Self-reported intensity adjusted minutes and Activity monitoring: during the 12-week programme,
Bioimpedance	Visceral fat, muscle mass, body fat, BMI	Baseline and start and end of the 12-week programme
Charlson Comorbidity score	Charlson Comorbidity score ≥/< 5	Baseline
Frailty	The Clinical Frailty Scale (CFS) is scored on a 1-9 scale based on clinical judgment of a patient's baseline functional status. It assesses mobility, function, cognitive ability, and comorbidities, ranging from 1 (Very Fit) to 9 (Terminally Ill)	Baseline, Immediately after the intervention
Digital Health Readiness	The Digital Health Readiness Questionnaire (DHRQ) is scored by summing responses from four main domains (15-75 range) using a 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree). A higher score indicates greater digital readiness.	Baseline, start and end of the 12-week programme
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	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Diet and nutrition	The diet section of the Trøndelag Health Study (HUNT3) is scored based on self-reported questionnaires-specifically, a short food frequency questionnaire (FFQ) designed to measure adherence to Norwegian dietary recommendations. The scoring typically translates frequency of intake into a diet quality index or a total adherence score, often based on a 0-5 or higher scale, where higher scores represent a healthier diet	Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Frailty	The Study of Osteoporotic Fractures (SOF) index will be used to measure frailty status. The SOF index includes three items: 1) weight loss > 5% in the last year, 2) inability to rise from a chair five times without using arms, and 3) reduced energy level. The questions have dichotomous response alternatives (yes/no). Patients who meet none of these criteria will be considered robust, one of the criteria are pre-frail, and two or three of these criteria are considered frail.	Baseline, Immediately after the intervention
HeartQol	14-item, heart-specific tool (for ischemic heart disease) scored on a 4-point Likert scale, ranging from 0 ("A lot") to 3 ("Not at all"). It measures physical (10 items) and emotional (4 items) quality of life, where higher mean scores (0 to 3) indicate better health-related quality of life	Immediately after the intervention
Beliefs About Medicines Questionnaire	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. Respondents rate 11 items on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).	Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Blood: Cardiac and inflammation markers. Urine: amino acid metabolites, organic acids and intermediates of fatty acid oxidation.	Baseline and end of the 12-week programme
Blood pressure		Baseline, start and end of the 12-week programme
Total number of ED contacts		Up to 10 years
Cognition	The 4AT is a 0-12 point delirium screening tool. Score 4 or more suggests delirium; 1-3 suggests cognitive impairment; 0 suggests no delirium/severe impairment	Baseline

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; Østfold University College; Bergen Municipality; Voss Sykehus; The Norwegian Heart and Lung Patients Association (LHL); 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
• Investigators: Principal Investigator: Tone M Norekvål, PhD, Haukeland University Hospital

Publications and helpful links

General Publications

• 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

• Study website

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Behavior; Treatment Adherence and Compliance; Health Behavior; Personal Satisfaction; Patient Compliance; Patient Acceptance of Health Care; Coronary Artery Disease; Psychological Well-Being; Medication Adherence
• Other Study ID Numbers: F-12624 (Western Norway Regional Health Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No