Trial Outcomes & Findings for Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment (NCT NCT03292705)
NCT ID: NCT03292705
Last Updated: 2026-02-20
Results Overview
The Activities of Daily Living (ADL) score is the sum of 15 items, creating a total score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 23 minus Baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline to Week 23
Results posted on
2026-02-20
Participant Flow
83 people were accessed to eligibility; 3 were not interested and 31 did not meet inclusion criteria.
Participant milestones
| Measure |
PEP+CCI
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
End of 4 week evaluation
STARTED
|
24
|
25
|
|
End of 4 week evaluation
COMPLETED
|
22
|
24
|
|
End of 4 week evaluation
NOT COMPLETED
|
2
|
1
|
|
End of week 10 evaluation
STARTED
|
22
|
24
|
|
End of week 10 evaluation
COMPLETED
|
22
|
21
|
|
End of week 10 evaluation
NOT COMPLETED
|
0
|
3
|
|
End of 23 weeks
STARTED
|
22
|
21
|
|
End of 23 weeks
COMPLETED
|
22
|
20
|
|
End of 23 weeks
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PEP+CCI
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
End of 4 week evaluation
Withdrawal by Subject
|
2
|
0
|
|
End of 4 week evaluation
Lost to Follow-up
|
0
|
1
|
|
End of week 10 evaluation
Withdrawal by Subject
|
0
|
2
|
|
End of week 10 evaluation
Lost to Follow-up
|
0
|
1
|
|
End of 23 weeks
Death
|
0
|
1
|
Baseline Characteristics
Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
PEP+CCI
n=24 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=25 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
86.75 years
STANDARD_DEVIATION 5.26 • n=14 Participants
|
86.04 years
STANDARD_DEVIATION 6.10 • n=14 Participants
|
86.39 years
STANDARD_DEVIATION 5.66 • n=29 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=14 Participants
|
16 Participants
n=14 Participants
|
31 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
18 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic, white
|
22 Participants
n=14 Participants
|
23 Participants
n=14 Participants
|
45 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic Black
|
1 Participants
n=14 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic More than One Race
|
1 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=14 Participants
|
25 Participants
n=14 Participants
|
49 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 10The Activities of Daily Living (ADL) score is the sum of 15 items, resulting in a total performance score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 10 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=21 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=21 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in ADL Score From Baseline to Week 10
|
0.00 score on a scale
Standard Deviation 2.28
|
-0.29 score on a scale
Standard Deviation 3.57
|
PRIMARY outcome
Timeframe: Baseline to Week 23The Activities of Daily Living (ADL) score is the sum of 15 items, creating a total score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 23 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=20 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in ADL Score From Baseline to Week 23
|
1.18 score on a scale
Standard Deviation 3.50
|
-0.10 score on a scale
Standard Deviation 4.68
|
PRIMARY outcome
Timeframe: Baseline to week 4EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=24 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Executive Function Measured by Examiner
|
0.14 composite raw score (original metric)
Standard Deviation 0.33
|
-0.02 composite raw score (original metric)
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Baseline to End of Week 10 EvaluationEXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=21 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Executive Function Measured by Examiner
|
0.38 composite score in the original metric
Standard Deviation 0.35
|
0.35 composite score in the original metric
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: Baseline to End of 23 WeeksEXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=20 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Executive Function Measured by Examiner
|
0.20 composite score in original metric
Standard Deviation 0.34
|
0.13 composite score in original metric
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Baseline to week 4The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=24 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Attitudes Toward Computers Questionnaire
|
0.05 score on a scale
Standard Deviation 5.07
|
0.33 score on a scale
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: Baseline to End of Week 10 EvaluationThe Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=21 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Attitudes Toward Computers Questionnaire
|
-0.86 score on a scale
Standard Deviation 11.37
|
1.00 score on a scale
Standard Deviation 7.93
|
SECONDARY outcome
Timeframe: Baseline to End of 23 WeeksThe Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=20 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Attitudes Toward Computers Questionnaire
|
0.18 score on a scale
Standard Deviation 6.61
|
0.80 score on a scale
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Baseline to Week 4The Brief Visuospatial Memory Test-Revised (BVMT-R) delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 4 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=24 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Brief Visuospatial Memory Test
|
0.50 score on a scale
Standard Deviation 2.76
|
2.76 score on a scale
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Baseline to Week 10The BVMT-R delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 10 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=21 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Brief Visuospatial Memory Test
|
-0.05 score on a scale
Standard Deviation 2.94
|
0.86 score on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline to week 23The BVMT-R delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 23 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=20 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Brief Visuospatial Memory Test
|
-0.05 score on a scale
Standard Deviation 2.94
|
0.40 score on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline to Week 4The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 4 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=24 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in EPCCE Sum Score From Baseline to Week 4
|
-0.55 score on a scale
Standard Deviation 1.87
|
-1.00 score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Baseline to Week 10The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 10 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=21 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in EPCCE Sum Score From Baseline to Week 10
|
-0.09 score on a scale
Standard Deviation 1.38
|
0.33 score on a scale
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Baseline to Week 23The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 23 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=20 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in EPCCE Sum Score From Baseline to Week 23
|
0.32 score on a scale
Standard Deviation 1.43
|
0.35 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline to Week 10The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 10 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=21 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in UFOV Score From Baseline to Week 10
|
-53.93 milliseconds (ms)
Standard Deviation 57.70
|
37.22 milliseconds (ms)
Standard Deviation 45.11
|
SECONDARY outcome
Timeframe: Baseline to Week 23The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 23 minus Baseline.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=19 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in UFOV Score From Baseline to Week 23
|
-57.14 milliseconds (ms)
Standard Deviation 58.63
|
-33.71 milliseconds (ms)
Standard Deviation 43.80
|
SECONDARY outcome
Timeframe: Baseline to week 23Mean change in self-perceived functioning in daily living activities as measured by the Activities of Daily Living - Prevention Instrument (ADL-PI). The ADL-PI is a sum score of 15 items, with a total score range of 0-60. Higher scores indicate more impaired functioning, while lower scores indicate better functioning.
Outcome measures
| Measure |
PEP+CCI
n=22 Participants
PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
|
Control+CCI
n=20 Participants
For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
|
|---|---|---|
|
Mean Change in Activities of Daily Living-Prevention Instrument
|
1.18 score on a scale
Standard Deviation 3.50
|
-0.10 score on a scale
Standard Deviation 4.68
|
Adverse Events
PEP+CCI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control+CCI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place