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

Summary

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.

Conditions

• Acute Coronary Syndrome

Interventions

OTHER

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

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™

Sponsors & Collaborators

• Ad scientiam

  lead OTHER

Principal Investigators

• Alain Cohen Solal, Prof · Lariboisière Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-31

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• France
• Italy
• Portugal
• Spain

Study Locations