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Strategy Game Supporting Goal Management Training Intervention

Primary Purpose

Acquired Brain Injury, Executive Dysfunction, Neuropsychological Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Game-Supported Goal Management Training
Information Group
Sponsored by
Klimmendaal Revalidatiespecialisten
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Any type of acquired brain injury of non-progressive nature in the past, being more than three months post injury. A Clinically meaningful score of executive complaints on the BRIEF-A. Aged between 18 and 70 years Referred for outpatient rehabilitation Living independently at home Exclusion Criteria: Inability to speak/ understand the Dutch language Co-morbidity that might affect outcome (e.g. neurodegenerative disorders, aphasia, neglect, and major psychiatric illness) Substance abuse No access to a smartphone, laptop or tablet Unable to look at a computer screen for 15 minutes Being unable to operate a keyboard or computer mouse

Sites / Locations

  • Klimmendaal Revalidatiespecialisten

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Game-Supported Goal Management Training

Information Group

Arm Description

Seven treatment sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist and cognitive trainer or occupational therapist.

Seven information sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist.

Outcomes

Primary Outcome Measures

Change from baseline performance on untrained IADL tasks immediately after the intervention
Standardized scale measuring performance of an untrained IADL task (int. al. the percent change in the number of correct steps) before (baseline) and after treatment (post treatment). The untrained IADL tasks will be divided into multiple steps using the GMT method. These steps will be assessed using four categories: 1) additional/unrelated; 2) absent/incomplete; 3) questionable/ineffective; 4) competent/correct, using task-specific assessment forms.

Secondary Outcome Measures

Change from baseline Goal Attainment Scaling (GAS) on untrained task performance immediately after the intervention
Quantifying the subjective improvement on untrained task performance
Change from baseline subjective strategy use immediately after the intervention
The subjective experience of strategy use in daily life and during the performance of IADL tasks, as measured by two short self-reported questionnaires.
Change from baseline participation as measured by the USER-P immediately after the intervention
"Utrecht Scale for Evaluation of Rehabilitation - Participation" (USER-P)
Change from baseline executive functioning as measured with the Zoo map test immediately after the intervention
Zoo map test
Change from baseline executive functioning as measured with the modified six elements test immediately after the intervention
Modified six elements test
Change from baseline executive functioning as measured with the Brixton immediately after the intervention
Brixton
Change from baseline subjective cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ) immediately after the intervention
Cognitive Failure Questionnaire (CFQ)
Change from baseline executive functioning as measured with the OxMET-NL immediately after the intervention
Oxford Multiple Errands Test - Dutch version (OxMET-NL)
Change from baseline subjective executive complaints immediately after the intervention
Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)
Change from baseline Goal Attainment Scaling (GAS) on treatment goals immediately after the intervention
Quantifying the achievement of treatment goals, only measured in the game-supported GMT group.
System Usability Scale (SUS) questionnaire
To evaluate the usability of the game-supported GMT treatment.
Technological Acceptance Model (TAM) questionnaire
To evaluate the user-acceptance of the game-supported GMT treatment.

Full Information

First Posted
November 4, 2022
Last Updated
June 28, 2023
Sponsor
Klimmendaal Revalidatiespecialisten
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1. Study Identification

Unique Protocol Identification Number
NCT05621941
Brief Title
Strategy Game Supporting Goal Management Training Intervention
Official Title
A Strategy Game Supporting Goal Management Training Intervention for the Treatment of Executive Problems After Acquired Brain Injury: a Randomized Controlled Pilot Study for Usability and Preliminary Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
May 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klimmendaal Revalidatiespecialisten

4. Oversight

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

5. Study Description

Brief Summary
Many brain-injured patients referred for outpatient rehabilitation have difficulties with planning, problems solving, and reasoning. These difficulties can be characterized as executive deficits, which can vary from relatively mild to rather severe. Executive deficits lead to real-life everyday disorganization and difficulties in instrumental activities of daily living (IADL tasks). Goal Management Training (GMT) is a successful treatment for executive deficits and helps to structure activities in daily life. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. Patients are taught compensatory strategies not to strengthen the executive functions, but to enable them to minimize disabilities and participation problems and to function more independently in daily life. The currently implemented GMT treatment in the Netherlands is aimed at relearning two specific tasks. However, to adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks, which requires a comprehensive, time-consuming and thus labour-intensive treatment. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care, and because of their machine learning algorithms which tailors the game to the level of the individual player. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with no transfer to improvements in daily life functioning. The present study fills a gap in the literature by investigating a new developed treatment that incorporates GMT and a treatment supporting strategy game in a pilot sample of brain injured patients. The primary objective of this pilot study is to obtain an efficacy estimate and investigate the feasibility of GMT with a new game that incorporates strategy training in improving executive functions in a pilot sample of brain-injured patients. This study investigates usability and acceptability of our new developed GMT treatment to brain-injured patients in the chronic phase (>3 months post-onset), and obtains an efficacy estimate, focusing on transfer of treatment effects to untrained (instrumental) activities of daily living. Chronic brain-injured patients will be allocated to the game-supported GMT treatment or to an information group using block randomization. It will be an assessor blind study in which researchers responsible for assessing or analyzing data will be blind for the received treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Executive Dysfunction, Neuropsychological Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Game-Supported Goal Management Training
Arm Type
Experimental
Arm Description
Seven treatment sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist and cognitive trainer or occupational therapist.
Arm Title
Information Group
Arm Type
Active Comparator
Arm Description
Seven information sessions given once a week (60 minutes) under guidance of a clinical neuropsychologist.
Intervention Type
Behavioral
Intervention Name(s)
Game-Supported Goal Management Training
Intervention Description
The investigational treatment is based on a compensatory strategy training named Goal Management Training (GMT). The investigational treatment will include GMT in combination with a compensatory strategy game which allows the patient to learn and apply the algorithm of GMT in a safe and controlled environment. This means that the multiple steps of the GMT will be learned during the treatment sessions under guidance of a therapist as well as in their own home environment by using the compensatory strategy game.
Intervention Type
Behavioral
Intervention Name(s)
Information Group
Intervention Description
In the information group, patients are informed about non-specific consequences of acquired brain injury, aimed to increase patient's insight into their condition and with that improving functioning. The program consists of the following subjects: 1) cause of brain injury, 2) information processing and attention, 3) memory, 4) planning and performance, 5) fatigue, 6) changes in emotion and behavior and 7) processing and adjustments.
Primary Outcome Measure Information:
Title
Change from baseline performance on untrained IADL tasks immediately after the intervention
Description
Standardized scale measuring performance of an untrained IADL task (int. al. the percent change in the number of correct steps) before (baseline) and after treatment (post treatment). The untrained IADL tasks will be divided into multiple steps using the GMT method. These steps will be assessed using four categories: 1) additional/unrelated; 2) absent/incomplete; 3) questionable/ineffective; 4) competent/correct, using task-specific assessment forms.
Time Frame
Baseline and immediately after the intervention
Secondary Outcome Measure Information:
Title
Change from baseline Goal Attainment Scaling (GAS) on untrained task performance immediately after the intervention
Description
Quantifying the subjective improvement on untrained task performance
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline subjective strategy use immediately after the intervention
Description
The subjective experience of strategy use in daily life and during the performance of IADL tasks, as measured by two short self-reported questionnaires.
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline participation as measured by the USER-P immediately after the intervention
Description
"Utrecht Scale for Evaluation of Rehabilitation - Participation" (USER-P)
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline executive functioning as measured with the Zoo map test immediately after the intervention
Description
Zoo map test
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline executive functioning as measured with the modified six elements test immediately after the intervention
Description
Modified six elements test
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline executive functioning as measured with the Brixton immediately after the intervention
Description
Brixton
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline subjective cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ) immediately after the intervention
Description
Cognitive Failure Questionnaire (CFQ)
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline executive functioning as measured with the OxMET-NL immediately after the intervention
Description
Oxford Multiple Errands Test - Dutch version (OxMET-NL)
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline subjective executive complaints immediately after the intervention
Description
Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)
Time Frame
Baseline and immediately after the intervention
Title
Change from baseline Goal Attainment Scaling (GAS) on treatment goals immediately after the intervention
Description
Quantifying the achievement of treatment goals, only measured in the game-supported GMT group.
Time Frame
Baseline and immediately after the intervention
Title
System Usability Scale (SUS) questionnaire
Description
To evaluate the usability of the game-supported GMT treatment.
Time Frame
Immediately after the intervention
Title
Technological Acceptance Model (TAM) questionnaire
Description
To evaluate the user-acceptance of the game-supported GMT treatment.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any type of acquired brain injury of non-progressive nature in the past, being more than three months post injury. A Clinically meaningful score of executive complaints on the BRIEF-A. Aged between 18 and 70 years Referred for outpatient rehabilitation Living independently at home Exclusion Criteria: Inability to speak/ understand the Dutch language Co-morbidity that might affect outcome (e.g. neurodegenerative disorders, aphasia, neglect, and major psychiatric illness) Substance abuse No access to a smartphone, laptop or tablet Unable to look at a computer screen for 15 minutes Being unable to operate a keyboard or computer mouse
Facility Information:
Facility Name
Klimmendaal Revalidatiespecialisten
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6813 GG
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://trialsearch.who.int/Trial2.aspx?TrialID=NL9200
Description
Related Info

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Strategy Game Supporting Goal Management Training Intervention

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