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Study suspended due to the COVID-19 pandemic. Some study procedures are not curently possible for many investigational sites.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: standard of care | Other | The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day. |
|
| Group B: standard of care + mobile application CardiCare™ | Other | The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wear an actigraph | Other | Between visits, tha patient will have to:
|
| 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 |
| 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. |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Cohen Solal, Prof | Hopital Lariboisière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corentin Celton hospital | Issy-les-Moulineaux | France | ||||
| Lariboisière hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741536 | Derived | Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4. |
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| Use the mobile application CardiCare™ and wear an actigraph | Other | Between visits, tha patient will have to:
|
|
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 |
| Paris |
| France |
| Saint-Yves clinic | Rennes | France |
| Brie Cardiac Readaptation Centre | Villeneuve-Saint-Denis | France |
| Maugeri Scientific Clinical Institutes | Pavia | Italy |
| Scientific Institute of Hospitalization and Care San Raffaele Pisana | Roma | Italy |
| CHOL - Santa Cruz hospital | Carnaxide | Portugal |
| CHULN - Santa Marta hospital | Lisbon | Portugal |
| Carlos III - La Paz Hospital | Madrid | Spain |
| Santiago University Hospital | Santiago de Compostela | Spain |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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