Clinical trial NCT04198779: Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
Official title: Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Heart Decompensation
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Evaluation of the use of "MonCoeur" application on the impact of patient health self-care
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: Evaluation of the use of "MonCoeur" application on hospitalisation rate
timeFrame: 3, 6 and 12 months
measure: Evaluation of the use of "MonCoeur" application on cardiovascular parameters
timeFrame: 3, 6 and 12 months
measure: Evaluation of the use of "MonCoeur" application on patient compliance
timeFrame: 3, 6 and 12 months
measure: Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire
timeFrame: 3, 6 and 12 months
measure: Evaluation of the use of "MonCoeur" application on patient physical activity
timeFrame: 3, 6 and 12 months
measure: Describe how often and how the application is used by patients
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens - Picardie - Site Sud
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: CHRU de Lille
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Universitaire Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: CHU de ROUEN - Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulon
country: France
facility: Hôpital Sainte Musse de Toulon
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Hôpital Bicêtre
name: Emmanuelle BERTHELOT, MD
role: PRINCIPAL_INVESTIGATOR
References: