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Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03005626
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
We aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

Condition or disease Intervention/treatment Phase
Congenital Heart Diseases Other: Therapeutic education Other: Standard follow-up Not Applicable

Detailed Description:

The number of adults with congenital heart diseases (CHD) is increasing. However, many young adults are lost to follow-up even in experienced tertiary care centers. American and European guidelines recommend to improve the management of young adults with CHD. Structured therapeutic education programs are therefore needed to optimize the transfer to adult healthcare. Our tertiary care CHD center recently implemented a transition program and simultaneously we decided to measure its impact. Indeed we need data from randomized trials in this filed. After previous controlled quality of life studies among children and adults with CHD, we chose to use the health-related quality of life (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.

We assume that patients who participate in our program will improve their quality of life compared to controls. If we demonstrate the benefit of our program, it will have important consequences for patients with CHD and eventually for patients with other chronic medical conditions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life
Actual Study Start Date : January 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Therapeutic education
Structured therapeutic education programs
Other: Therapeutic education
Active Comparator: Control group
standard outpatient follow-up
Other: Standard follow-up

Primary Outcome Measures :
  1. Quality of life [ Time Frame: follow up of patients over 12 months ]
    Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient from 13 years to 25 years inclusive.
  • Carrying of Congenital Heart Disease as defined in the International Classification.
  • Possible follow-up for one year on one of the three hospital center.
  • Informed consent of the patient for adults and, parents or legal guardians for minors.
  • Affiliation to a social security system.

Exclusion Criteria:

  • Non-francophone,
  • Severe intellectual impairment.

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 identifier (NCT number): NCT03005626

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Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital Recruiting
Montpellier, France, 34295
Contact: Charlene BREDY, MD   
Contact: Pascal AMEDRO, MD, PhD         
Sub-Investigator: Pascal AMEDRO, MD, PhD         
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT03005626     History of Changes
Other Study ID Numbers: 9752
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities