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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,000
12-week digital cardiac rehabilitation
Haukeland University Hospital
Bergen, Norway
RECRUITINGComposite 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.
Time frame: Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.
Cardiovascular mortality
Time to cardiovascular cause death from randomization.
Time frame: 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)
Time frame: 1, 3, 5 years
All-cause mortality
Time to all-cause death from randomization
Time frame: 1, 3, 5 years
All-cause Emergency Department contact
Emergency Department (ED) contact and home, ED and observation, ED and admission (\>24 hours)
Time frame: 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.
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)
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
Time frame: 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.
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
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)
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
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).
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
Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry).
Time frame: 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.
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
Smoking status (smoker, previous smoker, never smoker)
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)
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
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)
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).
Time frame: 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.
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
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).
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)
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.
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)
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.
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
VO2peak, Self-reported intensity adjusted minutes, activity monitoring
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
Visceral fat, muscle mass, body fat, BMI
Time frame: Baseline and start and end of the 12-week programme
Charlson Comorbidity score
Charlson Comorbidity score ≥/\< 5
Time frame: 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)
Time frame: 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.
Time frame: 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
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
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
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
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.
Time frame: 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
Time frame: 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).
Time frame: Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
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