Acute Coronary Syndrome
Conditions
Keywords
CardiCare, Coronary heart disease, Application, Mobile, Acute coronary syndrome
Brief 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.
Interventions
OTHERWear 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
OTHERUse 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
Ad scientiam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From day 0 to month 6 | Proportion of participants with stabilised or improved VO2max 6 months, as measured by Cardiopulmonary Exercise Test in group B versus group A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups. | From day 0 to month 3 | Proportion of participants in group B versus group A with stabilised or improved VO2max at 3 months compared to baseline. |
| To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups | From day 0 to month 3 and month 6 | Comparison in continous measurement of cardiorespiratory fitness as measured by Cardiopulmonary Exercise Test |
| To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups. | From day 0 to month 3 and month 6 | Identification of items will be based in continuous measurement of total cholesterol, Low Density Lipoproteins Cholesterol, High Density lipoproteins Cholesterol. |
| To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups. | From day 0 to month 3 and month 6 | Identification of items will be based in continuous measurement of fasting glucose |
| To evaluate CardiCare™ impact on change in weight at 3 months and 6 months versus baseline in both groups. | From day 0 to month 3 and month 6 | Identification of items will be based on measured clinical exam |
| To evaluate CardiCare™ impact on change in Body Mass Index at 3 months and 6 months versus baseline in both groups. | From day 0 to month 3 and month 6 | Identification of items will be based on measured clinical exam |
| To evaluate CardiCare™ impact on change in Hip and waist circumference at 3 months and 6 months versus baseline in both groups. | From day 0 to month 3 and month 6 | Identification of items will be based on measured clinical exam |
| To evaluate the impact of CardiCare™ on anxiety at 3 and 6 months versus baseline, in both groups. | From day 0 to month 3 and month 6 | Identification of the items will be measure with Hospital Anxiety and Depression Scale questionnaires |
| To evaluate the impact of CardiCare™ on quality of life at 3 and 6 months versus baseline, in both groups. | From day 0 to month 3 and month 6 | Identification of the items will be measure with Health-Related Quality of Life questionnaires |
| To evaluate medication compliance in both groups. | From day 0 to month 6 | Compliance will based on the duration of medication interruption. |
| To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up. | From day 0 to month 6 | The global physical activity will be monitored using continuous variables of the actigraph |
| To compare time to first hospital readmission among both groups (all-cause, cardiac, and noncardiac) and their predictors. | From day 0 to month 3 and month 6 | Comparison will based on the number of hospital readmission |
| 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. | From day 0 to month 3 and month 6 | Identification of the items based on the number of hospital readmission |
| To evaluate the impact of CardiCare™ on employment status at 3 and 6 months versus baseline in both groups. | From day 0 to month 3 and month 6 | Identification of the items will based on the time to return to work and the time in sick leave |
| To evaluate CardiCare™ impact on exercise performed in group B. | From day 0 to month 6 | Comparison of the exercise performed during the follow up of participants in group B. |
| To evaluate CardiCare™ impact on cardiovascular risk factors control at 3 and 6 months versus baseline in both groups. | From day 0 to month 3 and month 6 | Identification of the cardiovascular risk factors will based on the clinical exam and blood tests |
| To evaluate, for each session, the correlation between self-reported physical activities in CardiCare™ and those collected by the actigraph in group B. | From day 0 to month 6 | Identification of items will be based on the physical activities reported by the patient in CardiCare™ and actigraph |
| To identify patterns of VO2max evolution between D0, M3 and M6, between both groups | From day 0 to month 3 and month 6 | Identification of items will be based on the measures of cardiorespiratory fitness as measured by Cardiopulmonary Exercise Test |
| To evaluate CardiCare™ impact on sleep quality between groups over time of follow-up. | From day 0 to month 6 | Identification of the items be based on actigraph |
| To evaluate the safety of the CardiCare™ use. | From day 0 to month 6 | Safety will be assessed by the numbers of adverse events and adverse events related to the use of the application CardiCare™. |
| To collect patients and investigators feedback on the CardiCare™ application. | From day 0 to month 6 | Descriptive analysis of patients and investigators satisfaction related to the mobile application. |
| To compare differences of reported cardiovascular events at 3 and 6 months, in both groups. | From day 0 to month 3 and month 6 | Comparison will based on the number of cardiovascular events occured |
Countries
France, Italy, Portugal, Spain
Outcome results
None listed