- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506852
Using Teleneuropsychology to Optimize Cognition in Healthy Aging: the Web-based Breakfast Game
Training Executive Control in Cognitively Healthy Aging: the Web-based Breakfast Game
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 60-75
- Willingness to adhere to training protocol
- Adequate English proficiency
Exclusion Criteria:
- Low test scores (below 26 on the Montreal Cognitive Assessment)
- Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.
- Taking medications known to influence cognitive performance.
- Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.
- Enrolled in a concurrent study that could affect the outcome of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Strategy Training
Participants will play the Breakfast Game with training strategy.
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Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion.
Participants will learn to play the game using specific strategies, in order to optimize the performance.
Other Names:
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Active Comparator: Regular Approach
Participants will play the Breakfast Game without training strategy.
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Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion.
Participants will learn to play the game under regular game instructions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in the Breakfast Game Performance: Number of Tables Set Score
Time Frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
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Change in the total number of tables set.
In the computerized task, participants are asked to set tables for four guests.
When finished, one point is given.
Higher scores represent a better outcome.
This metric represents a change in the score = the higher means improvement in the performance.
The total score ranges between 0 and 12; the total change score ranged from -3 to +3.
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Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
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Changes in the Breakfast Game Performance: Cooking Time Range of Stop Times Scores
Time Frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
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Change in cooking time (milliseconds) between food items.
In the computerized task, participants are asked to cook different food types.
Scores reflect the difference between the first and last food item that was stopped cooking.
Lower scores (closest to zero) represent a better outcome.
This metric represents a change in the score = the lower means improvement on the performance.
The total score ranges between 0.3 and 315; the total change score ranges from -40 to +40.
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Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
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Change in Breakfast Game Performance: Cooking Time Discrepancy Scores
Time Frame: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
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Change in cooking time (milliseconds) in each food type.
In the computerized task, participants are asked to cook different food types.
Scores reflect the average absolute values of the difference between the required and actual cooking time of each item.
Lower scores (closest to zero) represent a better outcome.
This metric represents a change in the score = the lower means improvement in the performance.
The total score ranges between 0.3 and 175; The total change score ranges from -20 to +20.
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Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12
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Transfer to Complex Executive/Attention Control Measure (Proximal Outcome).
Time Frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Accuracy on the Alphanumeric Task.
This metric represents a change in the score.
The higher the means more improvement in the performance.
The total change score ranged from -0.1 to +0.1
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Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Transfer to Executive Functions Composite Z-Score (Distal Outcome)
Time Frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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The Executive Functions Composite Z-Score represents an ability based on performance in four tests: Letter-Number Sequencing, Wisconsin Card Sorting Test, Stroop, and Useful Field of View. Each of these test measures aspects of executive functions, including: divided attention, working memory, inhibitory control, and cognitive flexibility. To calculate the Executive Functions Composite Score, Z-score values were computed in each of the four tests. We then averaged the Z-scores into a single Z-score measure. The central value (Z-score of 0) represents the average performance of the sample in each test. Standard deviation above the mean (higher Z-score values) represents better performance. The total Z-score ranged between -7 and 5. (Values not used for clinical diagnosis, sample cognitively healthy). This metric represents CHANGE in the Executive Functions Composite Score = the higher values represent more improvement in the performance. The total change score ranged from -2 + 2. |
Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Transfer to the General Self-efficacy Scale (Distal Outcome)
Time Frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Scores on a scale that measures perception about self-efficacy.
Total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
The change in the scale ranged from -4 to 9.
This metric represents a change in the score = the higher means improvement in the performance.
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Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Transfer to Beck Depression Inventory (Distal Outcome)
Time Frame: Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Score on a scale that measures depression symptoms.
Total score ranges between 0 and 63, with a higher score indicating more depression symptoms.
The change in the scale ranged from +3 to -9.
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Within the 2 weeks before intervention starts; and the 6th week, after the last (12th) training session. (Measure represent change between pre and post training)
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Transfer to Beck Anxiety Inventory (Distal Outcome)
Time Frame: Within the 2 weeks before intervention starts, and the 6th week, after the last (13th) training session. (Measure represent the change between pre and post training)
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Score on a scale that measures anxiety symptoms.
Total score ranges between 0 and 63, with a higher score indicating more anxiety symptoms.
The change in the scale ranged from +6 to -6.
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Within the 2 weeks before intervention starts, and the 6th week, after the last (13th) training session. (Measure represent the change between pre and post training)
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Transfer to Cognition-Leisure Questionnaire (Distal Outcome)
Time Frame: Within the 2 weeks before intervention starts, and the 6th week, after the last (12th) training session. (Measure represent the change between pre and post training)
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Score on a scale reflecting engagement/frequency in leisure & cognitive activities.
Total score ranges between 0 and 80, with a higher score indicating more frequency in leisure/cognitive activities.
The change in the scale ranged from -9 to 9.
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Within the 2 weeks before intervention starts, and the 6th week, after the last (12th) training session. (Measure represent the change between pre and post training)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharon Sanz Simon, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT4773
- 1K99AG078561-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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