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Clinical Trials/NCT05479630
NCT05479630
Completed
Not Applicable

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

University Hospital, Ghent1 site in 1 country81 target enrollmentNovember 5, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease in Adolescence
Sponsor
University Hospital, Ghent
Enrollment
81
Locations
1
Primary Endpoint
Change in disease-related knowledge of adolescents of the intervention group (paired test)
Status
Completed
Last Updated
3 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
November 5, 2015
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

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

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

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.

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

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

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.

Secondary Outcomes

  • 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)
  • 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 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 Sites (1)

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