Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

NCT ID: NCT03005626

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-11-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Congenital Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Therapeutic education

Structured therapeutic education programs

Group Type EXPERIMENTAL

Therapeutic education

Intervention Type OTHER

Control group

standard outpatient follow-up

Group Type ACTIVE_COMPARATOR

Standard follow-up

Intervention Type OTHER

Interventions

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Therapeutic education

Intervention Type OTHER

Standard follow-up

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 38864791 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33468144 (View on PubMed)

Other Identifiers

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9752

Identifier Type: -

Identifier Source: org_study_id

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