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

NCT05479630 | Completed

• 1 other identifier: 2015-1037
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease in Adolescence; Transitional Care

Keywords

Transitional care

Outcome Measures

Primary Outcomes (2)

• Change in disease-related knowledge of adolescents of the intervention group (paired test)

  Total knowledge score assesed by the Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD): and consists of 27 multiple choice questions for girls and 25 items for boys (Philip Moons et al., 2001). The total knowledge score consists of a ratio of the sum of correct answers to the total number of questions resulting in a 0-100 scale, where a higher score reflects a better disease-related knowledge.

  At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation

• Comparison between disease-related knowledge scores of adolescents of the intervention group and adolescents of the control group

  Total knowledge score assesed by the Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD): and consists of 27 multiple choice questions for girls and 25 items for boys (Philip Moons et al., 2001). The total knowledge score consists of a ratio of the sum of correct answers to the total number of questions resulting in a 0-100 scale, where a higher score reflects a better disease-related knowledge.

  Through study completion, an average of 1 year from the transfer consultation

Secondary Outcomes (4)

• Change in health-related quality of life of adolescents of the intervention group (paired test)

  At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation

• Comparison between levels of health-related quality of life of adolescents of the intervention group and adolescents of the control group

  Through study completion, an average of 1 year from the transfer consultation

• Comparison of transfer experiences between adolescents of the intervention group and the adolescents of the control group

  Through study completion, an average of 1 year from the transfer consultation

• Comparison of transfer experiences between parents in the intervention group and control group

  Through study completion, an average of 1 year from the transfer consultation

Study Arms (2)

Adolescents and their parent of the intervention group

EXPERIMENTAL

Adolescents and their parent who are participating in TWAH

Other: Transition With a Heart (TWAH)

Adolescents and their parent of the control group

NO INTERVENTION

Adolescents and their parent who are not participating in TWAH

Interventions

Transition With a Heart (TWAH) 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 intervention group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (4)

• 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.

  PMID: 31758312 BACKGROUND

• 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.

  PMID: 11410567 BACKGROUND

• 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.

  PMID: 25149686 BACKGROUND

• 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.

  PMID: 11300418 BACKGROUND

Related Links

• Reference no. 3
• Reference no. 4

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: July 29, 2022
• Study Start: November 5, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)