EF Intervention in Children With Severe Congenital Heart Disease
NCT05198583, Not applicable, Completed, University Children's Hospital, Zurich
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | EF Intervention in Children With Severe Congenital Heart Disease | ClinicalTrials.gov |
| NCT number | NCT05198583 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 42 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University Children's Hospital, Zurich | ClinicalTrials.gov |
| Conditions | Heart Defects, Congenital, Executive Dysfunction | ClinicalTrials.gov |
| Interventions | E-Fit | ClinicalTrials.gov |
| First posted | 2022-01-20 | ClinicalTrials.gov |
| Last updated | 2024-12-20 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Fun and cognitive demand | 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. | ClinicalTrials.gov |
| Primary | Children's Feeling Scale | 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. | ClinicalTrials.gov |
| Primary | Acceptance and Feasibility scale | 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. | ClinicalTrials.gov |
| Primary | Completion rate (Objective Feasibility): | 5 minutes | Frequency (amount of participants who completed the training)/(total amount of participants enrolled) | ClinicalTrials.gov |
| Primary | Observed engagement | 2 minutes | Engagement of the participant during coaching sessions rated on a 7-point Likert scale | ClinicalTrials.gov |
| Primary | Session data | 5 minutes | duration, number of completed sessions, and for the computerized training, the coaching, and the card games | ClinicalTrials.gov |
| Primary | Recruitment rate | 5 minutes | amount of participants who agreed to participate/amount of invited participants | ClinicalTrials.gov |
| Primary | E-Fit Fidelity Measurement System tool | 8 hours | Tool to check whether the intervention was implemented as intended, answered by "yes" and "no" for each item | ClinicalTrials.gov |
| Primary | Feedback in coaching sessions | 5 minutes | qualitative feedback during the sessions about practicality of the intervention | ClinicalTrials.gov |
| Primary | Observed involvement | 5 minutes | involvement of the coach rated in 3 questions on a 7-point Likert scale | ClinicalTrials.gov |
| Primary | Session rating scale | 2 minutes | 4 questions about the practicality of the session rated by the participant | ClinicalTrials.gov |
| Primary | Retention rate | 2 minutes | participants who finished the study/participants who enrolled | ClinicalTrials.gov |
| Primary | Occurrence of adverse events (AEs) | From Start of the study until the end of the study, assessed up to 25 months | Amount of adverse events | ClinicalTrials.gov |
| Primary | Behavior Rating Inventory of Executive Function (BRIEF) | 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). | ClinicalTrials.gov |
| Primary | Color word Interference Task (D-KEFS) | 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). | ClinicalTrials.gov |
| Primary | Go/NoGo Test battery for attention testing (TAP) | 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). | ClinicalTrials.gov |
| Primary | Trail-Making-Test (D-KEFS) | 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. | ClinicalTrials.gov |
| Primary | Number-Letter-sequencing (WISC-V) | 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). | ClinicalTrials.gov |
| Primary | Tower Task from the (D-KEFS) | 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. | ClinicalTrials.gov |
| Primary | Balloon Analogue Risk Task (BART) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Balloon Risk | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Letter Matching Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)