Evaluation of a Prototype Smartphone Application of Personalized Care for Coronary Artery Disease (AppET-Coeur)

August 26, 2021 updated by: University Hospital, Toulouse

Implementation and Evaluation of a Prototype Smartphone Application of Personalized Care of Patients After Hospitalization for Coronary Artery Disease

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:

  1. assess the rate of use of the application
  2. to determine the ideal target population of the application
  3. to evaluate the effectiveness of the application
  4. to measure the risks and potential limitations of its use
  5. to determine the medical and economic impact of this application

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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:

  1. assess the rate of use of the application
  2. to determine the ideal target population of the application
  3. to evaluate the effectiveness of the application
  4. to measure the risks and potential limitations of its use
  5. 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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Appet HEART
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
Device: Appet HEART
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours ou use per patient per month
Time Frame: 12 months
Hours of use of the new smartphone application per patient per month
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Marc Labrunee, Dr, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/14/7417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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