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

Not Applicable

Terminated

• Conditions: Heart Decompensation; Heart Failure

• Registration Number: NCT04198779
• Lead Sponsor: French Cardiology Society

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.

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-02-12
• Status Verified: 2023-11
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the use of "MonCoeur" application on the impact of patient health self-care	3, 6 and 12 months	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".

Secondary Outcome Measures

Name	Time	Method
Evaluation of the use of "MonCoeur" application on patient compliance	3, 6 and 12 months	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.
Evaluation of the use of "MonCoeur" application on patient physical activity	3, 6 and 12 months	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.
Evaluation of the use of "MonCoeur" application on hospitalisation rate	3, 6 and 12 months	Comparison between the 2 study arms on the number of days without hospitalisation
Describe how often and how the application is used by patients	3, 6 and 12 months	Calculation of the number and type of parameters filled in the application.
Evaluation of the use of "MonCoeur" application on cardiovascular parameters	3, 6 and 12 months	Comparison between the 2 study arms of Brain Natriuretic Peptid (nanograms / liter)
Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire	3, 6 and 12 months	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.

Trial Locations

Locations (16)

CHU Amiens - Picardie - Site Sud; 🇫🇷 Amiens, France

Hospices Civils de Lyon; 🇫🇷 Bron, France

CHU Henri Mondor; 🇫🇷 Créteil, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

CHRU de Lille; 🇫🇷 Lille, France

Groupe Hospitalier Sud Ile de France; 🇫🇷 Melun, France

CHU Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Universitaire Pitié Salpêtrière; 🇫🇷 Paris, France

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