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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Heart Decompensation
• Intervention / Treatment: Device: APPLI

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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens - Picardie - Site Sud
  • Bron, France, 69677
    • Hospices Civils de Lyon
  • Créteil, France, 94010
    • CHU Henri Mondor
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Le Kremlin-Bicêtre, France, 94275
    • Hôpital Bicêtre
  • Lille, France, 59037
    • CHRU de Lille
  • Melun, France, 77000
    • Groupe Hospitalier Sud Ile de France
  • Montpellier, France, 34295
    • CHU Arnaud de Villeneuve
  • Paris, France, 75010
    • Hopital Lariboisiere
  • Paris, France, 75908
    • Hopital Europeen Georges Pompidou
  • Paris, France, 75651
    • Hopital Universitaire Pitie Salpetriere
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Rouen, France, 76031
    • CHU de Rouen - Hopital Charles Nicolle
  • Strasbourg, France, 67091
    • CHRU de Strasbourg
  • Toulon, France, 83100
    • Hôpital Sainte Musse de Toulon
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APPLI; Care support with implementation of the application	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.
No Intervention: CONTROL; Conventional care support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Investigators: Principal Investigator: Emmanuelle BERTHELOT, MD, Hôpital Bicêtre

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019-01 (NANT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No