Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases
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|ClinicalTrials.gov Identifier: NCT03005626|
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Diseases||Other: Therapeutic education Other: Standard follow-up||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Therapeutic education
Structured therapeutic education programs
Other: Therapeutic education
Active Comparator: Control group
standard outpatient follow-up
Other: Standard follow-up
- 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.
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): NCT03005626
|Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital||Recruiting|
|Montpellier, France, 34295|
|Contact: Charlene BREDY, MD firstname.lastname@example.org|
|Contact: Pascal AMEDRO, MD, PhD|
|Sub-Investigator: Pascal AMEDRO, MD, PhD|