Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

NCT03005626 | Completed

• 1 other identifier: 9752
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physiological parameters

  Follow up of patients over 12 months

• Ricci and Gagnon score

  Follow up of patients over 12 months

• Leuven Knowledge score

  Follow up of patients over 12 months

• Disease severity

  Follow up of patients over 12 months

• Anxiety and depression

  Follow up of patients over 12 months

Study Arms (2)

Therapeutic education

EXPERIMENTAL

Structured therapeutic education programs

Other: Therapeutic education

Control group

ACTIVE COMPARATOR

standard outpatient follow-up

Other: Standard follow-up

Interventions

Therapeutic education OTHER

Therapeutic education

Standard follow-up OTHER

Control group

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Non-francophone,
• Severe intellectual impairment.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, 34295, France

Location

Related Publications (2)

• Bredy C, Werner O, Huguet H, Guillaumont S, Auer A, Requirand A, Lavastre K, Abassi H, De La Villeon G, Vincenti M, Gavotto A, Vincent R, Pommier V, Dulac Y, Souletie N, Acar P, Karsenty C, Guitarte A, Berge M, Marguin G, Masseron MP, Pages L, Bourrel G, Engberink AO, Million E, Huby AC, Leobon B, Picot MC, Amedro P. Efficacy of a Transition Program in Adolescents and Young Adults With Congenital Heart Disease: The TRANSITION-CHD Randomized Controlled Trial. J Adolesc Health. 2024 Aug;75(2):358-367. doi: 10.1016/j.jadohealth.2024.04.022. Epub 2024 Jun 10.

  PMID: 38864791 RESULT

• 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.

  PMID: 33468144 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

FR (1)