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Low recrutement rate
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Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.
The aim of this study is to demonstrate that the use of a special application dedicated to the monitoring of heart failures disease has a favorable impact on the occurrence of readmissions and, ultimately, cardiovascular mortality. The aim of this study is also to demonstrate that the use of this "MonCœur" application improves symptoms, quality of life, treatment compliance, diet compliance, and physical activity in patient with heart failure disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APPLI | Experimental | Care support with implementation of the application |
|
| CONTROL | No Intervention | Conventional care support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APPLI | Device | The support with the digital application is including a 10-minutes training about the use of the digital application at the beginning of the study. Patient will have to register information about their Heart failure disease (weight, shortness of breath, fatigue, mood, cardiologist appointments, blood results, ...). During each routine consultation, patients will be encouraged to use the digital app, and the obstacles encountered will be explored and resolved. In addition, participants will receive an email containing relevant information and, every three months, an email reminder of the use of the application. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the use of "MonCoeur" application on the impact of patient health self-care | Comparison between the 2 study arms of the score of the European Heart Failure Self-care Behaviour Scale, consisting of 9 items each evaluated on a 5-point Likert scale, and allowing the calculation of a standardized global score from 0 to 100: the highest score indicating better "self-care". | 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the use of "MonCoeur" application on hospitalisation rate | Comparison between the 2 study arms on the number of days without hospitalisation | 3, 6 and 12 months |
| Evaluation of the use of "MonCoeur" application on cardiovascular parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuelle BERTHELOT, MD | Hôpital Bicêtre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens - Picardie - Site Sud | Amiens | 80054 | France | |||
| Hospices Civils de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42225494 | Derived | Berthelot E, Audureau E, Bouleti C, Duval AJ, Canu M, Itier R, Legrand L, Alloujami M, Tartiere JM, Degroote P, Logeart D, Roubille F, Martin AC, Damy T, Bauer F. Impact of the MonCoeur smartphone application on self-care and quality of life in heart failure: The APPLIMONCOEUR randomized trial. Arch Cardiovasc Dis. 2026 May 15:S1875-2136(26)00208-1. doi: 10.1016/j.acvd.2026.04.007. Online ahead of print. |
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Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
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Comparison between the 2 study arms of Brain Natriuretic Peptid (nanograms / liter) |
| 3, 6 and 12 months |
| Evaluation of the use of "MonCoeur" application on patient compliance | Comparison between the 2 study arms on percentage of appointments scheduled versus appointments honored. Comparison between the 2 study arms of the score of the treatment observance scale Ameli. | 3, 6 and 12 months |
| Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire | Comparison between the 2 study arms of the score of the Minnesota Living with Heart Failure Questionnaire. It provides a total score (range 0-105, from best to worst), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score. | 3, 6 and 12 months |
| Evaluation of the use of "MonCoeur" application on patient physical activity | Comparison between the 2 study arms of the score of the Qappa ("questionnaire d'activité physique pour personnes âgées" / translation in english: "physical activity questionnaire for seniors") physical activity questionnaire. The QAPPA uses the calculation system of the volume of physical activity per minute and per week and classified as high, moderate, or low level. | 3, 6 and 12 months |
| Describe how often and how the application is used by patients | Calculation of the number and type of parameters filled in the application. | 3, 6 and 12 months |
| Bron |
| 69677 |
| France |
| CHU Henri Mondor | Créteil | 94010 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| CHRU de Lille | Lille | 59037 | France |
| Groupe Hospitalier Sud Ile de France | Melun | 77000 | France |
| CHU Arnaud de Villeneuve | Montpellier | 34295 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Hôpital Universitaire Pitié Salpêtrière | Paris | 75651 | France |
| Hôpital Européen Georges Pompidou | Paris | 75908 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| CHU de ROUEN - Hôpital Charles Nicolle | Rouen | 76031 | France |
| CHRU de Strasbourg | Strasbourg | 67091 | France |
| Hôpital Sainte Musse de Toulon | Toulon | 83100 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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