EF Intervention in Children With Severe Congenital Heart Disease (E-FIT)

University of Zurich (UZH)

Status: Completed

Conditions: Heart Defects, Congenital; Executive Dysfunction

Treatments: Other: E-Fit

Study type: Interventional

Funder types: Other

Identifiers

NCT05198583

Teen Heart Intervention

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 10 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Born with CHD
• 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

• Failure to provide a signed Informed Consent
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: E-Fit

Control

No Intervention group

Description:

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.