Heart Defects, CongenitalE-FITNCT05198583
EF Intervention in Children With Severe Congenital Heart Disease
A study testing E-Fit in people with Heart Defects, Congenital and Executive Dysfunction, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Heart Defects, Congenital, Executive Dysfunction
- What is being tested?
- E-Fit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2022to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Children's Hospital Zurich
Zurich, Canton of Zurich, 8032
About this study
Official title: Executive Function and Brain Development in Adolescents With Severe Congenital Heart Disease (Teen Heart Study)
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.
- Conditions
- Heart Defects, Congenital, Executive Dysfunction
- Being tested
- E-Fit
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: E-Fit |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Children'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.
Measured: 5 minutes
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.
Measured: 5 minutes
Completion rate (Objective Feasibility):
Frequency (amount of participants who completed the training)/(total amount of participants enrolled)
Measured: 5 minutes
Observed engagement
Engagement of the participant during coaching sessions rated on a 7-point Likert scale
Measured: 2 minutes
Session data
duration, number of completed sessions, and for the computerized training, the coaching, and the card games
Measured: 5 minutes
Recruitment rate
amount of participants who agreed to participate/amount of invited participants
Measured: 5 minutes
E-Fit Fidelity Measurement System tool
Tool to check whether the intervention was implemented as intended, answered by "yes" and "no" for each item
Measured: 8 hours
Feedback in coaching sessions
qualitative feedback during the sessions about practicality of the intervention
Measured: 5 minutes
Observed involvement
involvement of the coach rated in 3 questions on a 7-point Likert scale
Measured: 5 minutes
Session rating scale
4 questions about the practicality of the session rated by the participant
Measured: 2 minutes
Retention rate
participants who finished the study/participants who enrolled
Measured: 2 minutes
Occurrence of adverse events (AEs)
Amount of adverse events
Measured: From Start of the study until the end of the study, assessed up to 25 months
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).
Measured: 15 minutes
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).
Measured: 5 minutes
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).
Measured: 5 minutes
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.
Measured: 5 minutes
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).
Measured: 10 minutes
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.
Measured: 15 minutes
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.
Measured: 10 minutes
Secondary outcomes (6)
The Family Relationship Index
27 questions answered "does apply" or "does not apply"
Measured: 10 minutes
Kidscreen-10
10 questions to assess the child's subjective health and well-being on a 5-point Likert scale
Measured: 5 minutes
Kidscreen-27
27 questions to assess the child's health and well-being from a parent's perspective on a 5-point Likert scale
Measured: 10-15 minutes
short form of the Conners-3
42 questions answered on a 4-point Likert scale and 2 open questions to screen for behavioral problems
Measured: 20 minutes
Social Responsiveness Scale
65 questions answered on a 4-point Likert scale to screen for behavioral problems
Measured: 20 minutes
Resilience Scale
13 questions answered on a 7-point Likert scale to assess resilience by acceptance of self-, life- and personal competencies
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Jul 2022
- Primary completion24 May 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198583
- Sponsor's protocol ID
- Teen Heart Intervention
- Acronym
- E-FIT
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmid AS, Ehrler M, Bunge SA, Kretschmar O, Landolt MA, Rousson V, Tuura RO, Wehrle FM, Latal B. Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease in Switzerland: a randomised controlled feasibility study. BMJ Open. 2026 May 8;16(5):e107681. doi: 10.1136/bmjopen-2025-107681.
PubMed 42103386Schmid 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.
PubMed 37945305
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function and Brain Development in Adolescents With Severe Congenital Heart Disease (Teen Heart Study)
- ClinicalTrials.gov ID
- NCT05198583
- Acronym / sponsor ID
- E-FIT / Teen Heart Intervention
- Conditions
- Heart Defects, Congenital, Executive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: E-FitThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-FitThe 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. | Other | Intervention |
Primary outcome
Fun and cognitive demand
Time frame: 5 minutes
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.
Children's Feeling Scale
Time frame: 5 minutes
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
Time frame: 5 minutes
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):
Time frame: 5 minutes
Frequency (amount of participants who completed the training)/(total amount of participants enrolled)
Observed engagement
Time frame: 2 minutes
Engagement of the participant during coaching sessions rated on a 7-point Likert scale
Session data
Time frame: 5 minutes
duration, number of completed sessions, and for the computerized training, the coaching, and the card games
Recruitment rate
Time frame: 5 minutes
amount of participants who agreed to participate/amount of invited participants
E-Fit Fidelity Measurement System tool
Time frame: 8 hours
Tool to check whether the intervention was implemented as intended, answered by "yes" and "no" for each item
Feedback in coaching sessions
Time frame: 5 minutes
qualitative feedback during the sessions about practicality of the intervention
Observed involvement
Time frame: 5 minutes
involvement of the coach rated in 3 questions on a 7-point Likert scale
Session rating scale
Time frame: 2 minutes
4 questions about the practicality of the session rated by the participant
Retention rate
Time frame: 2 minutes
participants who finished the study/participants who enrolled
Occurrence of adverse events (AEs)
Time frame: From Start of the study until the end of the study, assessed up to 25 months
Amount of adverse events
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 15 minutes
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)
Time frame: 5 minutes
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)
Time frame: 5 minutes
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)
Time frame: 5 minutes
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)
Time frame: 10 minutes
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)
Time frame: 15 minutes
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)
Time frame: 10 minutes
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.
6 secondary outcomes
The Family Relationship Index
Time frame: 10 minutes
Kidscreen-10
Time frame: 5 minutes
Kidscreen-27
Time frame: 10-15 minutes
short form of the Conners-3
Time frame: 20 minutes
Social Responsiveness Scale
Time frame: 20 minutes
Resilience Scale
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 42103386Schmid AS, Ehrler M, Bunge SA, Kretschmar O, Landolt MA, Rousson V, Tuura RO, Wehrle FM, Latal B. Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease in Switzerland: a randomised controlled feasibility study. BMJ Open. 2026 May 8;16(5):e107681. doi: 10.1136/bmjopen-2025-107681.
- Derived from this study: PubMed 37945305Schmid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Fit in people with Heart Defects, Congenital and Executive Dysfunction, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fun and cognitive demand (time frame: 5 minutes). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.