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

Heart Failure Clinical Trial

— APPLIMONCOEUR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04198779
• Other study ID #: 2019-01
• Status: Terminated
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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 Européen Georges Pompidou	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Universitaire Pitié Salpêtrière	Paris
France	CHU de Poitiers	Poitiers
France	CHU de ROUEN - Hôpital Charles Nicolle	Rouen
France	CHRU de Strasbourg	Strasbourg
France	Hôpital Sainte Musse de Toulon	Toulon
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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