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

Primary Purpose

Heart Defects, Congenital, Executive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
E-Fit
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Defects, Congenital

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm 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.

The control group does not receive any intervention.

Outcomes

Primary Outcome Measures

Fun and cognitive demand
Subjective Feasibility, Fun and cognitive demand: the two questions "How fun was the training?" and "How much did you use your brain" are answered on a 5-point Likert scale (1 referring to not at all and 5 referring to very much). Both questions are treated as ordinal scaled and median and interquartile range will be reported.
Hulley's Feeling Scale
Subjective Feasibility, Affect 11-point single item bipolar scale (-5 referring to "very bad" and 5 referring to "very good"). The Hulley feeling scale is treated as ordinal scaled and median and interquartile range will be reported.
Acceptance and Feasibility scale
4-point Likert scale (1 referring to "don't agree at all" and 4 referring to "fully agree"). Treated as ordinal scaled and median and interquartile range, as well as percentages of persons who answered the items with 3 or 4, will be reported.
Completion rate (Objective Feasibility):
Frequency (amount of participants who completed the training)/(total amount of participants enrolled)

Secondary Outcome Measures

Behavior Rating Inventory of Executive Function (BRIEF)
The BRIEF assesses Executive Functions Behavior in everyday life. The results will be be transformed into a categorical variable with results > 1 SD defined as abnormal (T-scale >= 60).
Color word Interference Task (D-KEFS)
The D-KEFS Color-Word Interference Test is based on the classic Stroop task, which is primarily used to assess the ability to inhibit verbal responses (inhibition).
Go/NoGo Test battery for attention testing (TAP)
In this test, 2 implementation forms with different stimulus material are offered. In the 1st condition, reaction times and errors are measured in a simple "Go/Nogo" condition with two stimuli (+ and x: 2 stimuli, one critical), in the 2nd more complex condition with 5 squares with different filling patterns, 2 of which are defined as critical (5 stimuli, 2 critical).
Trail-Making-Test (D-KEFS)
The D-KEFS Trail Making Test is a revision and extension of the classic alternating number and letter matching task, which is known as a proven instrument for assessing cognitive flexibility. With the help of four additional conditions, the basic abilities of visual scanning, connecting numbers and letters, and motor speed can be assessed. This results in a differentiated overall picture of the interaction of different basic and higher cognitive abilities.
Number-Letter-sequencing (WISC-V)
In number repeating, the subject is read a sequence of numbers and asked to repeat them in the same order (number repeating - forwards), in reverse order (number repeating - backwards) or in ascending order (number repeating - sequential).
Tower Task from the (D-KEFS)
The D-KEFS Tower Test is a revision of classic tower tasks in which discs are to be restacked with the help of three rods in such a way that given tower templates are replicated, while observing certain rules. Nine standardised tasks covering a difficulty spectrum from very easy to very difficult are designed to avoid floor and ceiling effects. The test measures, among other things, spatial planning ability, rule learning, inhibition of impulsive or perseverative response behaviour, as well as the development and maintenance of mental attitudes.
Balloon Analogue Risk Task (BART)
In the experiment, participants are presented with a balloon. The participant is prompted to inflate the balloon using the Right Arrow key. After successfully inflating the balloon by 1 unit, the participant receives five points. The more the participant inflates the balloon, the more points they receive. E-Prime randomly selects a number between 1 and 100 for each trial representing the total number of inflated units before the balloon bursts. If the participant inflates the balloon too much, it pops and no points are given. Participants also have the choice to press the Left Arrow to advance the trial while keeping their points. There is one practice trial and 5 critical trials.

Full Information

First Posted
December 7, 2021
Last Updated
November 7, 2022
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05198583
Brief Title
EF Intervention in Children With Severe Congenital Heart Disease
Acronym
E-FIT
Official Title
Executive Function and Brain Development in Adolescents With Severe Congenital Heart Disease (Teen Heart Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Executive Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group does not receive any intervention.
Intervention Type
Other
Intervention Name(s)
E-Fit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fun and cognitive demand
Description
Subjective Feasibility, Fun and cognitive demand: the two questions "How fun was the training?" and "How much did you use your brain" are answered on a 5-point Likert scale (1 referring to not at all and 5 referring to very much). Both questions are treated as ordinal scaled and median and interquartile range will be reported.
Time Frame
5 minutes
Title
Hulley's Feeling Scale
Description
Subjective Feasibility, Affect 11-point single item bipolar scale (-5 referring to "very bad" and 5 referring to "very good"). The Hulley feeling scale is treated as ordinal scaled and median and interquartile range will be reported.
Time Frame
5 minutes
Title
Acceptance and Feasibility scale
Description
4-point Likert scale (1 referring to "don't agree at all" and 4 referring to "fully agree"). Treated as ordinal scaled and median and interquartile range, as well as percentages of persons who answered the items with 3 or 4, will be reported.
Time Frame
5 minutes
Title
Completion rate (Objective Feasibility):
Description
Frequency (amount of participants who completed the training)/(total amount of participants enrolled)
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
The BRIEF assesses Executive Functions Behavior in everyday life. The results will be be transformed into a categorical variable with results > 1 SD defined as abnormal (T-scale >= 60).
Time Frame
15 minutes
Title
Color word Interference Task (D-KEFS)
Description
The D-KEFS Color-Word Interference Test is based on the classic Stroop task, which is primarily used to assess the ability to inhibit verbal responses (inhibition).
Time Frame
5 minutes
Title
Go/NoGo Test battery for attention testing (TAP)
Description
In this test, 2 implementation forms with different stimulus material are offered. In the 1st condition, reaction times and errors are measured in a simple "Go/Nogo" condition with two stimuli (+ and x: 2 stimuli, one critical), in the 2nd more complex condition with 5 squares with different filling patterns, 2 of which are defined as critical (5 stimuli, 2 critical).
Time Frame
5 minutes
Title
Trail-Making-Test (D-KEFS)
Description
The D-KEFS Trail Making Test is a revision and extension of the classic alternating number and letter matching task, which is known as a proven instrument for assessing cognitive flexibility. With the help of four additional conditions, the basic abilities of visual scanning, connecting numbers and letters, and motor speed can be assessed. This results in a differentiated overall picture of the interaction of different basic and higher cognitive abilities.
Time Frame
5 minutes
Title
Number-Letter-sequencing (WISC-V)
Description
In number repeating, the subject is read a sequence of numbers and asked to repeat them in the same order (number repeating - forwards), in reverse order (number repeating - backwards) or in ascending order (number repeating - sequential).
Time Frame
10 minutes
Title
Tower Task from the (D-KEFS)
Description
The D-KEFS Tower Test is a revision of classic tower tasks in which discs are to be restacked with the help of three rods in such a way that given tower templates are replicated, while observing certain rules. Nine standardised tasks covering a difficulty spectrum from very easy to very difficult are designed to avoid floor and ceiling effects. The test measures, among other things, spatial planning ability, rule learning, inhibition of impulsive or perseverative response behaviour, as well as the development and maintenance of mental attitudes.
Time Frame
15 minutes
Title
Balloon Analogue Risk Task (BART)
Description
In the experiment, participants are presented with a balloon. The participant is prompted to inflate the balloon using the Right Arrow key. After successfully inflating the balloon by 1 unit, the participant receives five points. The more the participant inflates the balloon, the more points they receive. E-Prime randomly selects a number between 1 and 100 for each trial representing the total number of inflated units before the balloon bursts. If the participant inflates the balloon too much, it pops and no points are given. Participants also have the choice to press the Left Arrow to advance the trial while keeping their points. There is one practice trial and 5 critical trials.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bea Latal, MD
Phone
001412667924
Email
bea.latal@kispi.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Bea Latal
Email
bea.latal@kispi.uzh.ch
Facility Information:
Facility Name
Children's Hospital Zurich
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bea Latal
Email
bea.latal@kispi.uzh.ch

12. IPD Sharing Statement

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EF Intervention in Children With Severe Congenital Heart Disease

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