Trial Outcomes & Findings for Using Teleneuropsychology to Optimize Cognition in Healthy Aging: the Web-based Breakfast Game (NCT NCT05506852)

NCT ID: NCT05506852

Last Updated: 2026-03-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

Results posted on

2026-03-19

Participant Flow

Participant milestones

Participant milestones
Measure
Experimental (Breakfast Game With Emphasis Change)
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.
Control (Breakfast Game Without the Emphasis Change)
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.
Overall Study
STARTED
19
19
Overall Study
COMPLETED
19
19
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Teleneuropsychology to Optimize Cognition in Healthy Aging: the Web-based Breakfast Game

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental Group (Breakfast Game With Emphasis Change)
n=19 Participants
Behavioral: Web-based training strategy As designed, participants (N=19) underwent a web-based training protocol where they played an online game that simulates a breakfast environment and performed everyday activities, such as "cooking" and "setting tables" in a multi-tasking fashion. Participants learnt to play the game using specific strategies in order to optimize their performance.
Control Group (Breakfast Game Without the Emphasis Change)
n=19 Participants
Behavioral: Web-based regular training (no strategy) Participants (n=19) underwent a web-based training protocol where they played an online game that simulates a breakfast environment and performed everyday activities, such as "cooking" and "setting tables" in a multi-tasking fashion. Participants learnt to play the game under regular game instructions.
Total
n=38 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=110 Participants
0 Participants
n=114 Participants
0 Participants
n=224 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=110 Participants
4 Participants
n=114 Participants
11 Participants
n=224 Participants
Age, Categorical
>=65 years
12 Participants
n=110 Participants
15 Participants
n=114 Participants
27 Participants
n=224 Participants
Age, Continuous
65.17 years
STANDARD_DEVIATION 2.9 • n=110 Participants
66.47 years
STANDARD_DEVIATION 4.2 • n=114 Participants
65.82 years
STANDARD_DEVIATION 3.69 • n=224 Participants
Sex: Female, Male
Female
16 Participants
n=110 Participants
15 Participants
n=114 Participants
31 Participants
n=224 Participants
Sex: Female, Male
Male
3 Participants
n=110 Participants
4 Participants
n=114 Participants
7 Participants
n=224 Participants
Race/Ethnicity, Customized
White
13 participants
n=110 Participants
17 participants
n=114 Participants
30 participants
n=224 Participants
Race/Ethnicity, Customized
Black/African-American
5 participants
n=110 Participants
2 participants
n=114 Participants
7 participants
n=224 Participants
Race/Ethnicity, Customized
Asian
1 participants
n=110 Participants
0 participants
n=114 Participants
1 participants
n=224 Participants

PRIMARY outcome

Timeframe: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Changes in the Breakfast Game Performance: Number of Tables Set Score
1.61 score on a scale (change)
Standard Deviation 0.15
1.43 score on a scale (change)
Standard Deviation 0.39

PRIMARY outcome

Timeframe: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Changes in the Breakfast Game Performance: Cooking Time Range of Stop Times Scores
-29.26 score on a scale
Standard Deviation 44.11
-14.51 score on a scale
Standard Deviation 15.79

PRIMARY outcome

Timeframe: Assessed at training session 1, week 1; training session 12, approximately 6 weeks. Data is reported for the change between session 1 and 12

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Change in Breakfast Game Performance: Cooking Time Discrepancy Scores
-3.85 score on a scale
Standard Deviation 5.73
-2.29 score on a scale
Standard Deviation 2.24

PRIMARY outcome

Timeframe: 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)

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

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Transfer to Complex Executive/Attention Control Measure (Proximal Outcome).
0.073 units on a scale
Standard Deviation 0.12
-0.010 units on a scale
Standard Deviation 0.10

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Transfer to Executive Functions Composite Z-Score (Distal Outcome)
0.636 units on a scale
Standard Deviation 1.51
-0.653 units on a scale
Standard Deviation 1.88

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Transfer to the General Self-efficacy Scale (Distal Outcome)
-0.87 score on a scale (change)
Standard Deviation 0.21
-0.89 score on a scale (change)
Standard Deviation 0.24

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Transfer to Beck Depression Inventory (Distal Outcome)
0.42 score on a scale (change)
Standard Deviation 0.22
0.30 score on a scale (change)
Standard Deviation 0.24

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Transfer to Beck Anxiety Inventory (Distal Outcome)
-0.139 score on a scale (change)
Standard Deviation 0.38
0.018 score on a scale (change)
Standard Deviation 0.70

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=19 Participants
Breakfast Game with Emphasis Change Strategy
Control Group
n=19 Participants
Breakfast Game without the Emphasis Change Strategy
Transfer to Cognition-Leisure Questionnaire (Distal Outcome)
-1.02 score on a scale (change)
Standard Deviation 0.5
0.94 score on a scale (change)
Standard Deviation 2.03

Adverse Events

Strategy Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Regular Approach

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharon Sanz Simon

Columbia University (previous); Rutgers University (current)

Phone: 973-972-2977

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place