Comorbidities and Coexisting ConditionseCardiacRehabNCT07590635
eCardiacRehab - a Hybrid Patient-Centered eHealth Programme
A study testing eCardiacRehab in people with Comorbidities and Coexisting Conditions and Ethics, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidities and Coexisting Conditions, Ethics, Continuity of Patient Care
- What is being tested?
- eCardiacRehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 21 May 2026to 31 Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Trond R Pettersen, PhD, +4748124938, trond.roed.pettersen@helse-bergen.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Comorbidities and Coexisting Conditions, Ethics, Continuity of Patient Care, Older Adults (65 Years and Older), Cost-Benefit Analysis, Adherence, Medication
- Being tested
- eCardiacRehab
- Keywords
- Cardiac Rehabilitation, Coronary Artery Disease, Percutaneous Coronary Intervention
- Medical subject headings
- Medication Adherence, Psychological Well-Being, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCardiacRehabOther
12-week digital cardiac rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No intervention |
| eCardiacRehab | Active comparator | Digital cardiac rehabilitation Receives: Other: eCardiacRehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.
Secondary outcomes (28)
Cardiovascular mortality
Time to cardiovascular cause death from randomization.
Measured: 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)
Measured: 1, 3, 5 years
All-cause mortality
Time to all-cause death from randomization
Measured: 1, 3, 5 years
All-cause Emergency Department contact
Emergency Department (ED) contact and home, ED and observation, ED and admission (>24 hours)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and start and end of the 12-week programme
Charlson Comorbidity score
Charlson Comorbidity score ≥/< 5
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start21 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Helse Vest IKT, Western Norway University of Applied Sciences, Youwell, University of Bergen, Østfold University College, Norsk råd for digital etikk, Helse Førde HF, University of Amsterdam, Center for Research on Cardiac Disease in Women, Nasjonal kompetansetjeneste Trening som medisin, RELIS Vest, Norwegian Centre for E-health Research, Bergen Municipality, Sunnfjord Municipality, Sogndal Municipality, Masfjorden Municipality, The Norwegian Heart and Lung Patients Association (LHL), E-helse Vestland, Yale University, University of Sydney, University of Cambridge, University of Regina, University of Copenhagen, Linkoeping University, Voss Sykehus
- Responsible party
- Sponsor
- Investigators
- Tone M Norekvål, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590635
- Sponsor's protocol ID
- F-12624
- Acronym
- eCardiacRehab
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38238118Norekval 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.
PubMed 37943676
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eCardiacRehab - a Randomized Controlled Trial on a Hybrid Home-Based Patient-Centered eHealth Programme With Tailored Solutions
- ClinicalTrials.gov ID
- NCT07590635
- Acronym / sponsor ID
- eCardiacRehab / F-12624
- Conditions
- Comorbidities and Coexisting Conditions, Ethics, Continuity of Patient Care, Older Adults (65 Years and Older), Cost-Benefit Analysis, Adherence, Medication
- Keywords
- Cardiac Rehabilitation, Coronary Artery Disease, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Helse Vest IKT, Western Norway University of Applied Sciences, Youwell, University of Bergen, Østfold University College, Norsk råd for digital etikk, Helse Førde HF, University of Amsterdam, Center for Research on Cardiac Disease in Women, Nasjonal kompetansetjeneste Trening som medisin, RELIS Vest, Norwegian Centre for E-health Research, Bergen Municipality, Sunnfjord Municipality, Sogndal Municipality, Masfjorden Municipality, The Norwegian Heart and Lung Patients Association (LHL), E-helse Vestland, Yale University, University of Sydney, University of Cambridge, University of Regina, University of Copenhagen, Linkoeping University, Voss Sykehus
- Study start
- 21 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No intervention |
| eCardiacRehab | Active comparator | Other: eCardiacRehabDigital cardiac rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCardiacRehab12-week digital cardiac rehabilitation | Other | eCardiacRehab |
Primary outcome
Composite clinical hierarchy of outcomes
Time frame: Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.
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.
28 secondary outcomes
Cardiovascular mortality
Time frame: 1, 3, 5 years
Cardiovascular Emergency Department contact
Time frame: 1, 3, 5 years
All-cause mortality
Time frame: 1, 3, 5 years
All-cause Emergency Department contact
Time frame: 1, 3, 5 years
The Myocardial Infarction Dimensional Assessment Scale (MIDAS)
Time frame: 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)
Time frame: Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, and 12-month follow-up.
RAND-12
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Maximum 1 year
EQ-5D-5L
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Pre-intervention, Immediately after the intervention, 6-month follow-up.
Health Literacy Questionnaire (HLQ)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Exercise
Time frame: VO2peak: start and end of the 12-week programme. Self-reported intensity adjusted minutes and Activity monitoring: during the 12-week programme,
Bioimpedance
Time frame: Baseline and start and end of the 12-week programme
Charlson Comorbidity score
Time frame: Baseline
Frailty
Time frame: Baseline, Immediately after the intervention
Digital Health Readiness
Time frame: Baseline, start and end of the 12-week programme
Fatigue
Time frame: 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
Time frame: Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Frailty
Time frame: Baseline, Immediately after the intervention
HeartQol
Time frame: Immediately after the intervention
Beliefs About Medicines Questionnaire
Time frame: Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 38238118Pettersen 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.
- Background: PubMed 37943676Norekval 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tone M Norekvål, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCardiacRehab in people with Comorbidities and Coexisting Conditions and Ethics, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trond R Pettersen, PhD (+4748124938, trond.roed.pettersen@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical hierarchy of outcomes (time frame: Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590635, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.