EF Intervention in Children With Severe Congenital Heart Disease
NCT ID: NCT05198583
Last Updated: 2024-12-20
Study Results
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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COMPLETED
NA
42 participants
INTERVENTIONAL
2022-07-01
2024-08-14
Brief Summary
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The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary. This intervention is tested on its feasibility. As the intervention was built in a patient centered manner, we expect it to be feasible, showing in a high adherence rate and satisfaction.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention
The intervention group will have a play-based intervention, including online games, analogue card games as well as a weekly coaching session to enhance executive functions.
E-Fit
The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary.
Control
The control group will get access to the online games, a list of the analogue card games used and fact sheets about possibilities to enhance executive functions in everyday life (which are used in the intervention group during the coachings) after finishing the study.
No interventions assigned to this group
Interventions
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E-Fit
The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary.
Eligibility Criteria
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Inclusion Criteria
* Underwent cardiopulmonary bypass surgery
* No genetic syndrome detected, no known dysmorphic-syndrome
* Aged 10 to 12
* written informed consent of parents and verbal informed consent of children
* EF deficits showing in screening
Exclusion Criteria
* Heart surgery without cardiopulmonary bypass
* Heart surgery not performed in Switzerland
* Any genetic syndrome detected
* large cerebral lesions (stroke, HIE) or severely neurologically impaired as a result of a serious event
10 Years
12 Years
ALL
No
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Locations
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Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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References
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Schmid AS, Ehrler M, Wehrle F, Tuura RO, Kretschmar O, Landolt M, Latal B. Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease: protocol for a randomised controlled feasibility study. BMJ Open. 2023 Nov 9;13(11):e073345. doi: 10.1136/bmjopen-2023-073345.
Other Identifiers
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Teen Heart Intervention
Identifier Type: -
Identifier Source: org_study_id