Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03005626
• Collaborator: (none)
• Enrollment: 178
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 47
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Diseases	Other: Therapeutic education; Other: Standard follow-up	N/A

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

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quality of life [follow up of patients over 12 months]

   Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03005626
• Other Study ID Numbers: 9752
• First Posted: Dec 29, 2016
• Last Update Posted: Feb 13, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Feb 13, 2018