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

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ClinicalTrials.gov Identifier: NCT02890732
Recruitment Status : Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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:

  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

Condition or disease Intervention/treatment Phase
Coronary Disease Device: Appet HEART Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation and Evaluation of a Prototype Smartphone Application of Personalized Care of Patients After Hospitalization for Coronary Artery Disease
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Hours ou use per patient per month [ Time Frame: 12 months ]
    Hours of use of the new smartphone application per patient per month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890732


Contacts
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Contact: Marc Labrunee, Dr 05 61 77 86 03 labrunee.m@chu-toulouse.fr
Contact: Appiah Béatrice 05 61 77 87 71 appiah.b@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Marc Labrunee, Dr University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02890732    
Other Study ID Numbers: RC31/14/7417
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases