Clinical trial NCT05479630: Evaluation of Transition With a Heart, a Transition Program for Adolescents With Congenital Heart Disease and Parents
Official title: A Prospective Quasi-Experimental Study to Evaluate Transition With a Heart, a Transition Project for Adolescents With Congenital Heart Disease and Their Parents With Focus on Disease Knowledge and Transitional Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease in Adolescence
Transitional Care
Keywords: Transitional care
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2022-07-29
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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
* Parents having children who are meeting the inclusion criteria above

Exclusion Criteria:

-

Primary outcomes:
measure: Change in disease-related knowledge of adolescents of the intervention group (paired test)
timeFrame: At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation
measure: Comparison between disease-related knowledge scores of adolescents of the intervention group and adolescents of the control group
timeFrame: Through study completion, an average of 1 year from the transfer consultation
Secondary outcomes:
measure: Change in health-related quality of life of adolescents of the intervention group (paired test)
timeFrame: At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation
measure: Comparison between levels of health-related quality of life of adolescents of the intervention group and adolescents of the control group
timeFrame: Through study completion, an average of 1 year from the transfer consultation
measure: Comparison of transfer experiences between adolescents of the intervention group and the adolescents of the control group
timeFrame: Through study completion, an average of 1 year from the transfer consultation
measure: Comparison of transfer experiences between parents in the intervention group and control group
timeFrame: Through study completion, an average of 1 year from the transfer consultation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.