Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).
Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LE9) (LE8 + PHQ-9). Intervention (DEEPER) will include informative modules (patient will choose among graphic medicine, video or interactive messaging) that will be delivered every two weeks via secure digital platform (or booklet if offline); monthly motivational messages; moderated peer-support forum with leaderboard; remote wearable step/sleep upload with personalized content assignment and feedback, linked to the hospital interactive digital platform (Rehab companion). Patients will be encouraged to have their own device to be adopted as lifelong maintenance. Nevertheless, centres will provide a smartwatch (fitbit) to all the patients enrolled in the trial as incentive for study participation and to uniformly collect study outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
306
A transcultural scientific digital platform (Rehab companion, Inselspital, University Hospital of Bern) for content delivery, feedback and digital biomarker monitoring will be made available.
KU Leuven, Kaatje Goetschalckx, KU Leuven
Leuven, Belgium
Carlo Cattaneo - LIUC University
Castellanza, Italy
Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane
Lumezzane, Italy
Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, representing Instituto Medicina Preventiva e Saúde Public (IMPSP) & Instituto de Saúde Ambiental (ISAMB)
Lisbon, Portugal
Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland
Bern, Switzerland
6-month change in composite Life's Essential 9 (LE9)
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).
Time frame: 6-month change
Individual LE8 sub-scores
Reported as differences in the absolute value among the two groups (median and (IQR)
Time frame: 6-month change
Major adverse cardiovascular event (MACE)
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
Time frame: 6 months
Major adverse cardiovascular event (MACE)
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
Time frame: 1 year
GAD 7
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
Time frame: Changes between baseline and 6-month follow-up
PHQ 9
depression score; The PHQ-9 score ranges from 0 to 27. Scores between 5 and 9 indicate the presence of subthreshold depression.
Time frame: Changes between baseline and 6-month follow-up
Physical fitness
distance achieved in 6-minute walking test
Time frame: Changes between baseline and 6-month follow-up
VO2 peak
cardiopulmonary test (CPET)
Time frame: Changes between baseline and 6-month follow-up
30 second sit-to -stand test
number of times the patient stands in 30 seconds
Time frame: Changes between baseline and 6-month follow-up
Hand-grip strength
maximum voluntary muscle strength measured by dynamometer
Time frame: Changes between baseline and 6-month follow-up
Steps per day
amount of steps during the day
Time frame: Changes between baseline and 6-month follow-up
Waist circumference
Waist circumference in cm
Time frame: Changes between baseline and 6-month follow-up
counter movement jump test.
Maximum power measured by dynamometer; difference in the absolute value among the two groups
Time frame: Changes between baseline and 6-month follow-up
Compliance with study treatment
Compliance with study treatment defined as number (percentage) of patients who will attend the sessions provided and will complete the study.
Time frame: 6 months
Economic impact of the CR pathways and financial sustainability: standard care versus stardard care plus the DEEPER package
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.
Time frame: 6 months
Acceptance of the usual care and the DEEPER package pathway using the Service User Technology Acceptance Questionnaire (SUTAQ) average values
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.
Time frame: 6 months
Assessment of social, ethical and equity dimensions.
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)
Time frame: 6 months
Social costs
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.
Time frame: 6 months
Safety endpoint
Musculo-skeletal injuries (requiring medical attention) and Arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia) requiring medical attention and an emergency room or ambulatory visit.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.