Evaluation of Transition With a Heart, a Transition Program for Adolescents With Congenital Heart Disease and Parents

NCT ID: NCT05479630

Last Updated: 2023-01-30

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

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-05

Study Completion Date

2022-12-01

Brief Summary

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The department of Congenital Heart Disease of the Ghent University Hospital (Belgium) developed a transition program dedicated to adolescents with congenital heart disease (CHD): 'Transition With a Heart“ (TWAH). TWAH was developed based on the Dutch program 'On your own feet“, starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centred communication, a joined transfer consultation and an appointed transition coordinator. TWAH focuses on promoting disease knowledge, autonomy and skills development of adolescents with CHD. Interventions encompass the use of a communication-paper, autonomously talking to professionals, individualized education and skills development plan. Interventions were selected from the highest sources of scientific evidence currently available including (quasi-) experimental studies, narrative literature reviews and expert opinions.

TWAH is the intervention in the conducted study. Hence, the intervention group are adolescents with CHD and their parents who are participating in TWAH. Adolescents and their parents who are transferred according to standard care (joined transfer consultation only) are identified as the control group and will be examined in the post test phase in order to be able to make comparisons with the intervention group. At baseline (the start of TWAH) participants of the control group already made the transfer to the adult ward.

The investigators consider the following hypothetical scenario:

\- TWAH will have a positive influence on disease knowledge and transition experiences of the participants.

Detailed Description

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Conditions

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Congenital Heart Disease in Adolescence Transitional Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

A prospective quasi-experimental study will be conducted using a pre (intervention group only) - post-test design.

In the pre-test only adolescents in the intervention group will be examined as baseline. During the post-test adolescents and parents of both the intervention group and control group will be examined in order to investigate differences between them and to better determine the influence of the intervention on the outcomes.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Adolescents and their parent of the intervention group

Adolescents and their parent who are participating in TWAH

Group Type EXPERIMENTAL

Transition With a Heart (TWAH)

Intervention Type OTHER

TWAH is a transition program, especially developed for adolescents with CHD and their parents. TWAH is starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centred communication, a joined transfer consultation and an appointed transition coordinator. TWAH focuses on promoting disease knowledge, autonomy and skills development of adolescents with CHD. Interventions encompass the use of a communication-paper, autonomously talking to professionals, individualized education and skills development plan. Details can be found in De Hosson et al, 2020 (1).

Adolescents and their parent of the control group

Adolescents and their parent who are not participating in TWAH

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transition With a Heart (TWAH)

TWAH is a transition program, especially developed for adolescents with CHD and their parents. TWAH is starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centred communication, a joined transfer consultation and an appointed transition coordinator. TWAH focuses on promoting disease knowledge, autonomy and skills development of adolescents with CHD. Interventions encompass the use of a communication-paper, autonomously talking to professionals, individualized education and skills development plan. Details can be found in De Hosson et al, 2020 (1).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of a CHD of great or moderate complexity (6)
* From the age of 12 years or older
* Must be able to complete the questionnaires
* Dutch speaking AND/OR

Exclusion Criteria

\-
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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de Hosson M, De Backer J, De Wolf D, De Groote K, Demulier L, Mels S, Vandekerckhove K, Goossens E. Development of a transition program for adolescents with congenital heart disease. Eur J Pediatr. 2020 Feb;179(2):339-348. doi: 10.1007/s00431-019-03515-4. Epub 2019 Nov 22.

Reference Type BACKGROUND
PMID: 31758312 (View on PubMed)

Moons P, De Volder E, Budts W, De Geest S, Elen J, Waeytens K, Gewillig M. What do adult patients with congenital heart disease know about their disease, treatment, and prevention of complications? A call for structured patient education. Heart. 2001 Jul;86(1):74-80. doi: 10.1136/heart.86.1.74.

Reference Type BACKGROUND
PMID: 11410567 (View on PubMed)

van Staa A, Sattoe JN. Young adults' experiences and satisfaction with the transfer of care. J Adolesc Health. 2014 Dec;55(6):796-803. doi: 10.1016/j.jadohealth.2014.06.008. Epub 2014 Aug 19.

Reference Type BACKGROUND
PMID: 25149686 (View on PubMed)

Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.

Reference Type BACKGROUND
PMID: 11300418 (View on PubMed)

Related Links

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Other Identifiers

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2015-1037

Identifier Type: -

Identifier Source: org_study_id

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