Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

Not Applicable

Completed

• Conditions: Congenital Heart Diseases
• Interventions: Other: Standard follow-up; Other: Therapeutic education

• Registration Number: NCT03005626
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-29
• Study Start: 2017-01
• Primary Completion: 2020-11-16
• Study Completion: 2020-11-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard follow-up	standard outpatient follow-up
Therapeutic education	Therapeutic education	Structured therapeutic education programs

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Disease severity	Follow up of patients over 12 months	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
Anxiety and depression	Follow up of patients over 12 months	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.
Ricci and Gagnon score	Follow up of patients over 12 months	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).
Leuven Knowledge score	Follow up of patients over 12 months	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.
Physiological parameters	Follow up of patients over 12 months	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

Trial Locations

Locations (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital; 🇫🇷 Montpellier, France