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

Ad scientiam

Status: Withdrawn

Conditions: Acute Coronary Syndrome

Treatments: Other: Use the mobile application CardiCare™ and wear an actigraph; Other: Wear an actigraph

Study type: Interventional

Funder types: Other

Identifiers

NCT04294940

CardiCare

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group A: standard of care

Other group

Description:

The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day.

Treatment:

Other: Wear an actigraph

Group B: standard of care + mobile application CardiCare™

Other group

Description:

The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™

Treatment:

Other: Use the mobile application CardiCare™ and wear an actigraph