Interest of the Smartphone Application MonCœur in the Follow-up of Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Interest of the Smartphone Application MonCœur in the Follow-up of Patients With Heart Failure

Conditions
-----------------
Heart Failure, Heart Decompensation

Intervention / Treatment
-----------------
* Device: APPLI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized for acute or decompensated heart failure Patient with a smartphone and able to use a digital application Beneficiary of a social protection scheme Patients benefiting from a telemedicine program can be included Exclusion Criteria: Acute coronary syndrome during ongoing hospitalization. Acute myocarditis, constrictive pericarditis, acute endocarditis during ongoing hospitalization. Isolated right heart failure of respiratory origin. Existence of a cause considered rapidly reversible to acute heart failure: tachyarrhythmia, excessive bradycardia, acute anemia, acute renal failure, malignant hypertension, overdose or cardiotoxic drug intoxication. Indication of cardiac surgery scheduled within 3 months after hospitalization, patients with Tavi or MItraclip expected within 3 months Extracardiac disease with short-term prognosis (progressive neoplasia). Refusal or incapacitation of language or psychic to sign informed consent Patients participating in an other biomedical research can not participate in this study for the first 6 months, not to interfere with the consultation process of the study. Pregnant or lactating women can't participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APPLI<br>Care support with implementation of the application | Device: APPLI<br>* 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.<br>|
| No Intervention: CONTROL<br>Conventional care support | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |