Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

Congenital Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005626
• Other study ID #: 9752
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 16, 2020

Study information

• Verified date: November 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Diseases
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Therapeutic education

• Standard follow-up

Locations

Country	Name	City	State
France	Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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