Clinical trial NCT03005626: Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Diseases
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 investigators decided to measure its impact. Indeed investigators need data from randomized trials in this filed. After previous controlled quality of life studies among children and adults with CHD, investigators chose to use the health-related quality of life (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.

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

Eligibility criteria: 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.

Primary outcomes:
measure: PedsQL 4.0 score
timeFrame: Follow up of patients over 12 months
Secondary outcomes:
measure: Physiological parameters
timeFrame: Follow up of patients over 12 months
measure: Ricci and Gagnon score
timeFrame: Follow up of patients over 12 months
measure: Leuven Knowledge score
timeFrame: Follow up of patients over 12 months
measure: Disease severity
timeFrame: Follow up of patients over 12 months
measure: Anxiety and depression
timeFrame: Follow up of patients over 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Study officials:
References:
citation: Bredy C, Werner O, Huguet H, Guillaumont S, Auer A, Requirand A, Lavastre K, Abassi H, De La Villeon G, Vincenti M, Gavotto A, Vincent R, Pommier V, Dulac Y, Souletie N, Acar P, Karsenty C, Guitarte A, Berge M, Marguin G, Masseron MP, Pages L, Bourrel G, Engberink AO, Million E, Huby AC, Leobon B, Picot MC, Amedro P. Efficacy of a Transition Program in Adolescents and Young Adults With Congenital Heart Disease: The TRANSITION-CHD Randomized Controlled Trial. J Adolesc Health. 2024 Aug;75(2):358-367. doi: 10.1016/j.jadohealth.2024.04.022. Epub 2024 Jun 10.
citation: Werner O, Bredy C, Lavastre K, Guillaumont S, De La Villeon G, Vincenti M, Gerl C, Dulac Y, Souletie N, Acar P, Pages L, Picot MC, Bourrel G, Oude Engberink A, Million E, Abassi H, Amedro P. Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. Health Qual Life Outcomes. 2021 Jan 19;19(1):23. doi: 10.1186/s12955-021-01668-1.