Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

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

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

Study Overview

• Status: Completed
• Conditions: Congenital Heart Diseases
• Intervention / Treatment: Other: Therapeutic education; Other: Standard follow-up

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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
PedsQL 4.0 score	Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.	Follow up of patients over 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters	Evolution of the physiological parameters during a cardiopulmonary exercise test performed on a treadmill according to a modified Bruce protocole. Evolution of the physiological parameters from month 0 to month 12	Follow up of patients over 12 months
Ricci and Gagnon score	Evolution of the physical activity assessed by Ricci and Gagnon scores from month 0 to month 12. Ricci and Ganon score is a physical activity self-questionnaire with a total score out of 40 (<16 points: not very active, between 16 and 32 points: fairly active, > 32 points: very active).	Follow up of patients over 12 months
Leuven Knowledge score	Evolution of the knowledge of the disease assessed by Leuven Knowledge scores from month 0 to month 12. The level of knowledge was assessed by the "transition readdiness assessment" instrument : 10-item questionnaire reflecting the basic knowledge of the diseases and its management.	Follow up of patients over 12 months
Disease severity	The evolution of the severity of the disease from month 0 to month 12 was assessed by the degree of heart failure (NYHA functionnal class I to IV) and the number of hospitalizations (in stays and days) for complications related to the congenital heart disease	Follow up of patients over 12 months
Anxiety and depression	The evolution of the levels of depression and/or anxiety from month 0 to month 12 was assessed respectively by : the BDI (Beck Depression Inventory) for young adults; the CDI (Child Depression Inventory) for adolescents; the STAI (State and Trait Anxiety Inventory) for adults and STAI-C (Children) for adolescents. A higher score is associated with a higher risk of depression/anxiety.	Follow up of patients over 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.
• Efficacy of a Transition Program in Adolescents and Young Adults With Congenital Heart Disease: The TRANSITION-CHD Randomized Controlled Trial Journal of Adolescent Health xxx(2024) 1-10 Accepted April 15, 2024 Article in press

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): November 16, 2020

Study Registration Dates

• First Submitted: December 26, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimated): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 9752