eCardiacRehab - a Hybrid Patient-Centered eHealth Programme

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.

• Cardiovascular mortality [Срок оценки: 1, 3, 5 years]
• Cardiovascular Emergency Department contact [Срок оценки: 1, 3, 5 years]
• All-cause mortality [Срок оценки: 1, 3, 5 years]
• All-cause Emergency Department contact [Срок оценки: 1, 3, 5 years]
• The Myocardial Infarction Dimensional Assessment Scale (MIDAS) [Срок оценки: 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) [Срок оценки: Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, and 12-month follow-up.]
• RAND-12 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Maximum 1 year]
• EQ-5D-5L [Срок оценки: 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 [Срок оценки: Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.]