Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

Hospitalization

Composite end-point of Emergency Department (ED) contact and home, ED and observation, ED and admission (\>24 hours), and death, whichever comes first.

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: 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).

Time frame: Up to 24 months

Maximal oxygen consumption (Vo2 max)

Maximal oxygen consumption (VO2max) as measured by cardiopulmonary exercise testing (CPET).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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). .

Time frame: 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)".

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 24 months

Change in sleep

The Sleep Sufficient Index (SSI) comprises 2 items assessing amount of actual and desired sleep.

Time frame: Up to 24 months

Medication adherence assessed by therapeutic drug monitoring

Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry)

Time frame: Baseline, 3 and 6 months

Blood samples

HbA1c (≤7.0%), lipids, cardiac and inflammation markers(e.g. troponins, natriuretic peptides and CRP).

Time frame: Baseline, 3 and 6 months.

Change in blood pressure

Blood pressure targets (\<120/70 mmHg at nurse visit; \<120/70 mmHg at home measurement)

Time frame: Up to end of programme

Change in biometrics

BMI (WHO- classification), visceral fat, muscle mass, body fat.

Time frame: Baseline, start and end of programme

Change in nicotine status

Self-reported change in nicotine status

Time frame: 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.

Time frame: 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.

Time frame: Throughout the 12-week program