NCT04294940

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ad scientiam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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™

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-03-04
• Last updated: 2021-06-29

Locations

10 sites across 4 countries: France, Italy, Portugal, Spain