Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

LC9 is defined by the American Heart Association's Life's Essential 8 (LE8), complemented by the Patient Health Questionnaire (PHQ-9), collectively referred to as "LC9 [blood pressure, non-high-density lipoprotein cholesterol (HDL), diet questionnaire, physical activity, smoking habits, sleep health, body mass index (BMI), hemoglobin A1c (HbA1c, %), PHQ9 from questionnaire).

Reported as differences in the absolute value among the two groups (median and (IQR)

defined as a composite of death of any cause, myocardial infarction, unplanned revascularization, rehospitalization for any cause, stroke, considered in a hierarchical way and as single endpoint

defined as a composite of death of any cause, myocardial infarction, unplanned revascularization, rehospitalization for any cause, stroke, considered in a hierarchical way and as single endpoint

anxiety score; Seven-item questionnaire that assesses the severity of anxiety symptoms over the past two weeks, with a total score ranging from 0 to 21

depression score; The PHQ-9 score ranges from 0 to 27. Scores between 5 and 9 indicate the presence of subthreshold depression.

distance achieved in 6-minute walking test

cardiopulmonary test (CPET)

number of times the patient stands in 30 seconds

maximum voluntary muscle strength measured by dynamometer

amount of steps during the day

Waist circumference in cm

Maximum power measured by dynamometer; difference in the absolute value among the two groups

Compliance with study treatment defined as number (percentage) of patients who will attend the sessions provided and will complete the study.

Direct costs of the two pathways, estimated using Activity Based Costing and financial sustainability measured with a budget impact analysis (BIA). Results reported as mean difference and standard deviation (SD) between groups.

Cost per patient and cost-effectiveness ratio will be calculated per group of treatment.

Responses to SUTAQ-based questionnaire administered to patients involved in the study, analyzed through a seven items scale scoring. Results reported as mean, p-value and linear regression models for enhanced care, increased accessibility, privacy and discomfort, care personnel concerns, telerehabilitation as substitution and satisfaction.

Perceptions reported by the patients, measured with a seven item Likert scale structured questionnaire based on the EUnetHTA Core Model dimensions, comparing standard care versus DEEPER package (mean and p-value)

Analysis of the indirect and out of pocket costs as average value in case of standard care and DEEPER package, to define the social costs related to the interventions.

Musculo-skeletal injuries (requiring medical attention) and Arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia) requiring medical attention and an emergency room or ambulatory visit.