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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

Tracking Information
First Submitted Date  ICMJE July 20, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Hours ou use per patient per month [ Time Frame: 12 months ]
Hours of use of the new smartphone application per patient per month
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Prototype Smartphone Application of Personalized Care for Coronary Artery Disease
Official Title  ICMJE Implementation and Evaluation of a Prototype Smartphone Application of Personalized Care of Patients After Hospitalization for Coronary Artery Disease
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Disease
Intervention  ICMJE Device: Appet HEART
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
Study Arms  ICMJE Experimental: Appet HEART
smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
Intervention: Device: Appet HEART
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02890732
Other Study ID Numbers  ICMJE RC31/14/7417
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Labrunee, Dr University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP