Evaluation of a Prototype Smartphone Application of Personalized Care for Coronary Artery Disease (AppET-Coeur)
Primary Purpose
Coronary Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Appet HEART
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with coronary heart disease aged 18 to 80 years, from an therapeutic patient education in Cardiology, capable of using a Smartphone application and with a Smartphone
Exclusion Criteria:
- Disorders of understanding, lack of long-term conditions, legal protection measure
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Appet HEART
Arm Description
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
Outcomes
Primary Outcome Measures
Hours ou use per patient per month
Hours of use of the new smartphone application per patient per month
Secondary Outcome Measures
Full Information
NCT ID
NCT02890732
First Posted
July 20, 2016
Last Updated
August 26, 2021
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02890732
Brief Title
Evaluation of a Prototype Smartphone Application of Personalized Care for Coronary Artery Disease
Acronym
AppET-Coeur
Official Title
Implementation and Evaluation of a Prototype Smartphone Application of Personalized Care of Patients After Hospitalization for Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Study Start Date
January 2017 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project will benefit from the results of the concept study conducted from July to October 2014 from groups of coronary patients. This first study will help to develop the precise contours of Appet HEART application for the production of the prototype version used in the clinical feasibility study.
The objectives of the feasibility study are:
assess the rate of use of the application
to determine the ideal target population of the application
to evaluate the effectiveness of the application
to measure the risks and potential limitations of its use
to determine the medical and economic impact of this application
Detailed Description
The patient education activities at the center in coronary artery disease, and have shown their efficiency, in combination with exercise training. Unfortunately the issue of educational care is low and maintaining long-term changes in the lifestyle and adherence to drug intake is limited which is a major health challenge because originally a recidivism rate too high coronary disease. In this context, therapeutic measures to enable patients to better integrate into their daily lives the recommendations in the long term are fundamental.
As part of the expertise of the Toulouse University Hospital in the field of therapeutic education coronary patient, the investigators decided to develop a Smartphone application that aims to strengthen and modernize the educational care to the patient. Based on an accurate and comprehensive assessment of lifestyle, from the technical elements of Smartphone support, but also on providing innovative educational materials (videos, interactive software...), the treat ( pharmacological or not: diet, physical activity, toxic consumption ) may thus be optimized according to the principle of telemedicine.
This project will benefit from the results of the concept study conducted from July to October 2014 from groups of coronary patients. This first study will help to develop the precise contours of Appet HEART application for the production of the prototype version used in the clinical feasibility study.
The objectives of the feasibility study are:
assess the rate of use of the application
to determine the ideal target population of the application
to evaluate the effectiveness of the application
to measure the risks and potential limitations of its use
to determine the medical and economic impact of this application
This is a single-center study. Patients will be recruited from the Toulouse University Hospital in cardiac services when patients came to coronary heart disease. After inclusion, patients receive an initial educational diagnosis that will determine individualized educational goals on the management of their coronary disease. Patients then receive training in the use of Appet HEART application. Using the application is provided on year.
The evaluation criteria of the study is original because conducted in hetero or self during the protocol monitoring time. Chronologically the investigators note:
An initial assessment hetero judgments criteria
A self- evaluation every three months for one year via their smartphone on some of these criteria via questionnaires
A final visit is scheduled to perform the same hetero- evaluation at the initial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Appet HEART
Arm Type
Experimental
Arm Description
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
Intervention Type
Device
Intervention Name(s)
Appet HEART
Intervention Description
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
Primary Outcome Measure Information:
Title
Hours ou use per patient per month
Description
Hours of use of the new smartphone application per patient per month
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with coronary heart disease aged 18 to 80 years, from an therapeutic patient education in Cardiology, capable of using a Smartphone application and with a Smartphone
Exclusion Criteria:
Disorders of understanding, lack of long-term conditions, legal protection measure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Labrunee, Dr
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of a Prototype Smartphone Application of Personalized Care for Coronary Artery Disease
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