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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A: standard of care

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

Group Type OTHER

Wear an actigraph

Intervention Type OTHER

Between visits, tha patient will have to:

* Follow the hygiene-dietetic recommendations given by their centre.
* Wear the actigraph night and day Patients

Group B: standard of care + mobile application CardiCare™

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

Group Type OTHER

Use the mobile application CardiCare™ and wear an actigraph

Intervention Type OTHER

Between visits, tha patient will have to:

* Follow the hygiene-dietetic recommendations given by their centre.
* Wear the actigraph night and day Patients
* wear their smartphone everyday and use the mobile application CardiCare™

Interventions

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Wear an actigraph

Between visits, tha patient will have to:

* Follow the hygiene-dietetic recommendations given by their centre.
* Wear the actigraph night and day Patients

Intervention Type OTHER

Use the mobile application CardiCare™ and wear an actigraph

Between visits, tha patient will have to:

* Follow the hygiene-dietetic recommendations given by their centre.
* Wear the actigraph night and day Patients
* wear their smartphone everyday and use the mobile application CardiCare™

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No