CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
E-Fitother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05198583
NCT05198583N/ACompleted

Executive Function and Brain Development in Adolescents With Severe Congenital Heart Disease (Teen Heart Study)

University Children's Hospital, Zurich·interventional·Posted Jan 20, 2022·Updated Dec 20, 2024

In Brief

A clinical study evaluating E-Fit for Heart Defects, Congenital and Executive Dysfunction. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Survival rates of children with severe congenital heart disease (CHD) have increased with ongoing medical progress over the past decades. However, many children with CHD face academic challenges during adolescence, which are associated with executive dysfunction. Executive functions (EF), higher-order cognitive processes allowing goal-directed behavior, can be particularly affected in children with CHD. To improve EF in affected children, a specific EF intervention has been developed. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 20, 2022
Enrollment StartJul 1, 2022
Primary CompletionMay 24, 2024
Study CompletionAug 14, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.5 years ago

Interventions

E-Fitother

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.