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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Withdrawn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
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 20, 2016
    Last Updated
    August 26, 2021
    Sponsor
    University Hospital, Toulouse
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    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    Withdrawn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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