Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

February 12, 2018 updated by: University Hospital, Montpellier

Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
follow up of patients over 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2017

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9752

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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