Back to resultsInterest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure (APPLIMONCOEUR)
Primary Purpose
Heart Failure, Heart Decompensation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
APPLI
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- CHU Amiens - Picardie - Site Sud
- Hospices Civils de LyonRecruiting
- CHU Henri Mondor
- CHU de GrenobleRecruiting
- Hôpital BicêtreRecruiting
- Centre Médico-Chirurgical - Pôle Santé Sud
- CHRU de LilleRecruiting
- CHU Arnaud de Villeneuve
- Hôpital Lariboisière
- Hôpital Universitaire Pitié SalpêtrièreRecruiting
- Hôpital Européen Georges PompidouRecruiting
- CHU de PoitiersRecruiting
- CHU de ROUEN - Hôpital Charles NicolleRecruiting
- CHRU de Strasbourg
- Hôpital Sainte Musse de ToulonRecruiting
- CHU de ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
APPLI
CONTROL
Arm Description
Care support with implementation of the application
Conventional care support
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Evaluation of the use of "MonCoeur" application on hospitalisation rate
Comparison between the 2 study arms on the number of days without hospitalisation
Evaluation of the use of "MonCoeur" application on cardiovascular parameters
Comparison between the 2 study arms of Brain Natriuretic Peptid (nanograms / liter)
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.
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.
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.
Describe how often and how the application is used by patients
Calculation of the number and type of parameters filled in the application.
Full Information
NCT ID
NCT04198779
First Posted
December 6, 2019
Last Updated
September 30, 2022
Sponsor
French Cardiology Society
1. Study Identification
Unique Protocol Identification Number
NCT04198779
Brief Title
Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
Acronym
APPLIMONCOEUR
Official Title
Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
August 12, 2025 (Anticipated)
Study Completion Date
August 12, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Decompensation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicentric, randomized, controlled, open, 2 parallel arms study, in 11 centers.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
APPLI
Arm Type
Experimental
Arm Description
Care support with implementation of the application
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Conventional care support
Intervention Type
Device
Intervention Name(s)
APPLI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the use of "MonCoeur" application on the impact of patient health self-care
Description
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".
Time Frame
3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Evaluation of the use of "MonCoeur" application on hospitalisation rate
Description
Comparison between the 2 study arms on the number of days without hospitalisation
Time Frame
3, 6 and 12 months
Title
Evaluation of the use of "MonCoeur" application on cardiovascular parameters
Description
Comparison between the 2 study arms of Brain Natriuretic Peptid (nanograms / liter)
Time Frame
3, 6 and 12 months
Title
Evaluation of the use of "MonCoeur" application on patient compliance
Description
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.
Time Frame
3, 6 and 12 months
Title
Evaluation of the use of "MonCoeur" application on patient quality of life: Minnesota Living with Heart Failure Questionnaire
Description
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.
Time Frame
3, 6 and 12 months
Title
Evaluation of the use of "MonCoeur" application on patient physical activity
Description
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.
Time Frame
3, 6 and 12 months
Title
Describe how often and how the application is used by patients
Description
Calculation of the number and type of parameters filled in the application.
Time Frame
3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle BERTHELOT, MD
Phone
+33 1 45 21 3735
Email
emmanuelle.berthelot@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa BERGOT
Phone
+33 1 44 90 70 33
Email
tessa.bergot@sfcardio.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BERTHELOT, MD
Organizational Affiliation
Hôpital Bicêtre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens - Picardie - Site Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otilia BUICIUC, MD
Email
Buiciuc.Otilia@chu-amiens.fr
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine JOBBE-DUVAL, MD
Phone
+33 4 72 11 88 80
Email
ajobbeduval@hotmail.fr
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud DAMY, MD
Phone
+33 1 49 81 22 53
Email
thibaud.damy@aphp.fr
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjorie CANU, MD
Phone
+33 4 76 76 76 95
Email
mcanu@chu-grenoble.fr
Facility Name
Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BERTHELOT, MD
Phone
+33145213735
Email
emmanuelle.berthelot@aphp.fr
Facility Name
Centre Médico-Chirurgical - Pôle Santé Sud
City
Le Mans
ZIP/Postal Code
72100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BACHELET, MD
Email
christophe.bachelet@me.com
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal De Groote, MD
Phone
+33 3 20 44 57 21
Email
pascal.degroote@chru-lille.fr
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François ROUBILLE, MD
Email
f-roubille@chu-montpellier.fr
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien LOGEAT, MD
Phone
+33 1 49 95 82 33
Email
damien.logeart@lrb.aphp-paris.fr
Facility Name
Hôpital Universitaire Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LEGRAND, MD
Email
lise.legrand@aphp.fr
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert HAGEGE, MD
Phone
+ 33 1 56 09 37 13
Email
albert.hagege@aphp.ff
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BOULETI, MD
Phone
+33 6 32 67 14 29
Email
claire.bouleti@gmail.com
Facility Name
CHU de ROUEN - Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie BURDEAU, MD
Phone
+33 2 32 88 54 06
Email
julie.burdeau@chu-rouen.fr
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérald ROULE, MD
Phone
+33 3 69 55 05 85
Email
jose.roule-gerald@chru-strasbourg.fr
Facility Name
Hôpital Sainte Musse de Toulon
City
Toulon
ZIP/Postal Code
83100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Michel TARTIERE, MD
Phone
+33 4 94 14 59 31
Email
Jean-Michel.Tartiere@ch-toulon.fr
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier LAIREZ, MD
Phone
+33 5 61 32 28 73
Email
lairez.o@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure
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