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

NCT ID: NCT04198779

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2023-11-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure Heart Decompensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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APPLI

Care support with implementation of the application

Group Type EXPERIMENTAL

APPLI

Intervention Type 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.

CONTROL

Conventional care support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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APPLI

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle BERTHELOT, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bicêtre

Locations

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CHU Amiens - Picardie - Site Sud

Amiens, , France

Site Status

Hospices Civils de Lyon

Bron, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

Groupe Hospitalier Sud Ile de France

Melun, , France

Site Status

CHU Arnaud de Villeneuve

Montpellier, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Hôpital Universitaire Pitié Salpêtrière

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CHU de ROUEN - Hôpital Charles Nicolle

Rouen, , France

Site Status

CHRU de Strasbourg

Strasbourg, , France

Site Status

Hôpital Sainte Musse de Toulon

Toulon, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2019-01

Identifier Type: -

Identifier Source: org_study_id