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 Overview
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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.

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Other: Wear an actigraph
* Other: Use the mobile application CardiCare™ and wear an actigraph


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: standard of care<br>The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day. | Other: Wear an actigraph<br>* Between visits, tha patient will have to: Follow the hygiene-dietetic recommendations given by their centre. Wear the actigraph night and day Patients<br>|
| Other: Group B: standard of care + mobile application CardiCare™<br>The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™ | Other: Use the mobile application CardiCare™ and wear an actigraph<br>* 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™<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy at 6 months of CardiCare™ in stabilising or improving the Cardiorespiratory Fitness of patients after acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program, versus standard care. | Proportion of participants with stabilised or improved VO2max 6 months, as measured by Cardiopulmonary Exercise Test in group B versus group A | From day 0 to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up. | The global physical activity will be monitored using continuous variables of the actigraph | From day 0 to month 6 | 
| To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups. | Proportion of participants in group B versus group A with stabilised or improved VO2max at 3 months compared to baseline. | From day 0 to month 3 | 
| To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups | Comparison in continous measurement of cardiorespiratory fitness as measured by Cardiopulmonary Exercise Test | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups. | Identification of items will be based in continuous measurement of total cholesterol, Low Density Lipoproteins Cholesterol, High Density lipoproteins Cholesterol. | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups. | Identification of items will be based in continuous measurement of fasting glucose | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on change in weight at 3 months and 6 months versus baseline in both groups. | Identification of items will be based on measured clinical exam | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on change in Body Mass Index at 3 months and 6 months versus baseline in both groups. | Identification of items will be based on measured clinical exam | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on change in Hip and waist circumference at 3 months and 6 months versus baseline in both groups. | Identification of items will be based on measured clinical exam | From day 0 to month 3 and month 6 | 
| To evaluate the impact of CardiCare™ on anxiety at 3 and 6 months versus baseline, in both groups. | Identification of the items will be measure with Hospital Anxiety and Depression Scale questionnaires | From day 0 to month 3 and month 6 | 
| To evaluate the impact of CardiCare™ on quality of life at 3 and 6 months versus baseline, in both groups. | Identification of the items will be measure with Health-Related Quality of Life questionnaires | From day 0 to month 3 and month 6 | 
| To evaluate medication compliance in both groups. | Compliance will based on the duration of medication interruption. | From day 0 to month 6 | 
| To compare differences of reported cardiovascular events at 3 and 6 months, in both groups. | Comparison will based on the number of cardiovascular events occured | From day 0 to month 3 and month 6 | 
| To compare time to first hospital readmission among both groups (all-cause, cardiac, and noncardiac) and their predictors. | Comparison will based on the number of hospital readmission | From day 0 to month 3 and month 6 | 
| To assess the cost-effectiveness to reduce 30-day, 3 months and 6 months readmission rates using CardiCare™ as an intervention compared to standard care. | Identification of the items based on the number of hospital readmission | From day 0 to month 3 and month 6 | 
| To evaluate the impact of CardiCare™ on employment status at 3 and 6 months versus baseline in both groups. | Identification of the items will based on the time to return to work and the time in sick leave | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on exercise performed in group B. | Comparison of the exercise performed during the follow up of participants in group B. | From day 0 to month 6 | 
| To evaluate CardiCare™ impact on cardiovascular risk factors control at 3 and 6 months versus baseline in both groups. | Identification of the cardiovascular risk factors will based on the clinical exam and blood tests | From day 0 to month 3 and month 6 | 
| To evaluate, for each session, the correlation between self-reported physical activities in CardiCare™ and those collected by the actigraph in group B. | Identification of items will be based on the physical activities reported by the patient in CardiCare™ and actigraph | From day 0 to month 6 | 
| To identify patterns of VO2max evolution between D0, M3 and M6, between both groups | Identification of items will be based on the measures of cardiorespiratory fitness as measured by Cardiopulmonary Exercise Test | From day 0 to month 3 and month 6 | 
| To evaluate CardiCare™ impact on sleep quality between groups over time of follow-up. | Identification of the items be based on actigraph | From day 0 to month 6 | 
| To evaluate the safety of the CardiCare™ use. | Safety will be assessed by the numbers of adverse events and adverse events related to the use of the application CardiCare™. | From day 0 to month 6 | 
| To collect patients and investigators feedback on the CardiCare™ application. | Descriptive analysis of patients and investigators satisfaction related to the mobile application. | From day 0 to month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CardiCare, Coronary heart disease, Application, Mobile, Acute coronary syndrome