Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome

Trial details

Who runs it

Ad scientiam

Trial code

NCT04294940

Record updated

2021. június 29.

Original description

Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost.Read full original descriptionShow less

Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost.

After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting.

Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle.

A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement.

Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max.

The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR.

The mobile application CardiCare™ consists of several modules:

* A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm * Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life * Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit * Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.

Inclusion: Subjects ≥ 18 years old; Diagnosis of an Acute Coronary Syndrome in the last 3 months, documented by angiographically-proven coronary artery disease or hospitalisation report; Graduated from a phase 2 cardiac rehabilitation, ready to enter a phase 3 CR at home; Having agreed to perform a cardiopulmonary exercise testing and blood count at the inclusion or having performed a cardiopulmonary exercise testing and blood count within the last week; Owning a personal smartphone (Android 5.0 or beyond / iPhone 5s and newer supporting IOS 12 and beyond) with Wifi or a data plan (3G/4G); Able to use a smartphone (e.g. no vision, hearing, cognitive or dexterity impairment); Having agreed to install CardiCare™ application on their own smartphone; Having agreed to wear an actigraph at all times and install the actigraph application (CenterPoint Sync) on their smartphone; Enrolled in or benefiting of a national health system; Having read the information sheet and signed the informed consent form; Non-inclusion Criteria:; Treated with Coronary Artery Bypass Grafting; Cardiac surgery in the last 12 weeks; Planned revascularisation or surgery in the next 6 months; Clinical heart failure or Left Ventricular Ejection Fraction < 40% documented within the last 2 months; Severe valvular disease; Severe pulmonary disease; Chronic kidney disease (stages III-V); Drug or/and alcohol abuse (as per clinician's judgment); Unstable angina; Osteoarticular condition or other reasons that limit exercise for more than 4 months (clinician's judgment); Uncontrolled hypertension (resting Diastolic BP>100 mmHg and resting Systolic BP >200 mmHg); Severe/uncontrolled arrhythmia; Systemic medical diseases that are likely to affect cognitive functioning; Pregnant women confirmed by a pregnancy test at the inclusion; Participation to another interventional clinical trial (category 1); Illiterate or not proficient in the language of the study country (French, Italian, Spanish or Portuguese according to the country); Person under guardianship or curatorship.

ClinicalTrials.gov NCT04294940