Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

University Hospital Center (CHU)

Status: Completed

Conditions: Congenital Heart Diseases

Treatments: Other: Therapeutic education; Other: Standard follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03005626

9752

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Therapeutic education

Experimental group

Description:

Structured therapeutic education programs

Treatment:

Other: Therapeutic education

Control group

Active Comparator group

Description:

standard outpatient follow-up

Treatment:

Other: Standard follow-up