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

NCT04198779 | Terminated

• 1 other identifier: 2019-01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 16

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.

Conditions

Heart Failure; Heart Decompensation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluation of the use of "MonCoeur" application on hospitalisation rate

  3, 6 and 12 months

• Evaluation of the use of "MonCoeur" application on cardiovascular parameters

  3, 6 and 12 months

• Evaluation of the use of "MonCoeur" application on patient compliance

  3, 6 and 12 months

• Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire

  3, 6 and 12 months

• Evaluation of the use of "MonCoeur" application on patient physical activity

  3, 6 and 12 months

Study Arms (2)

APPLI

EXPERIMENTAL

Care support with implementation of the application

Device: APPLI

CONTROL

NO INTERVENTION

Conventional care support

Interventions

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.

APPLI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (16)

CHU Amiens - Picardie - Site Sud

Amiens, 80054, France

Location

Hospices Civils de Lyon

Bron, 69677, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CHRU de Lille

Lille, 59037, France

Location

Groupe Hospitalier Sud Ile de France

Melun, 77000, France

Location

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Universitaire Pitié Salpêtrière

Paris, 75651, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU de ROUEN - Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Hôpital Sainte Musse de Toulon

Toulon, 83100, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Emmanuelle BERTHELOT, MD

  Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 13, 2019
• Study Start: February 12, 2020
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)