- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03292705
Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment (CogT-PACT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14618
- Brickstone/Saint John Meadow
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Rochester, New York, United States, 14642
- River Edge Manor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 ≤ MoCA ≤ 26
- RAVLT Delayed Recall Total Score ≤ 6 (or 1.5 SD below age-corrected norms)
- mild or no active depressive symptoms
- intact or mild deficits in IADL functioning
- if on AD medication (i.e., Memantine or cholinesterase inhibitors), antidepressant, or anxiolytics, no changes of doses in the 3 months prior to recruitment;
- age ≥60 years
- English-speaking
- adequate visual and hearing acuity for testing
- intact decision making capacity.
Exclusion Criteria:
- current enrollment in another cognitive improvement study;
- uncontrollable major depression: or other psychopathology identified by staff or medical records;
- having active legal guardian (indicating impaired capacity for decision making);
- medical history of AD or other types of dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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. |
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.
For instance, if music is among a person's lifelong interests, the system provides access to multiple music genres through jukebox, karaoke and therapeutic music applications that can be tailored to a particular activity and by individual interest (for instance, a preference for classic jazz).
As another example, for someone who likes travel or visiting new places, the interface offers access to Google Earth, guided tours, slide shows and regional facts and history.
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.
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Active Comparator: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in ADL Score From Baseline to Week 10
Time Frame: Baseline to Week 10
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The 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.
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Baseline to Week 10
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Mean Change in ADL Score From Baseline to Week 23
Time Frame: Baseline to Week 23
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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.
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Baseline to Week 23
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Mean Executive Function Measured by Examiner
Time Frame: Baseline to week 4
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EXAMINER 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.
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Baseline to week 4
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Mean Executive Function Measured by Examiner
Time Frame: Baseline to End of Week 10 Evaluation
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EXAMINER 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.
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Baseline to End of Week 10 Evaluation
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Mean Executive Function Measured by Examiner
Time Frame: Baseline to End of 23 Weeks
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EXAMINER 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.
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Baseline to End of 23 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Attitudes Toward Computers Questionnaire
Time Frame: Baseline to week 4
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The 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.
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Baseline to week 4
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Mean Change in Attitudes Toward Computers Questionnaire
Time Frame: Baseline to End of Week 10 Evaluation
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The 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.
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Baseline to End of Week 10 Evaluation
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Mean Change in Attitudes Toward Computers Questionnaire
Time Frame: Baseline to End of 23 Weeks
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The 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.
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Baseline to End of 23 Weeks
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Mean Change in Brief Visuospatial Memory Test
Time Frame: Baseline to Week 4
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The 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.
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Baseline to Week 4
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Mean Change in Brief Visuospatial Memory Test
Time Frame: Baseline to Week 10
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The 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.
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Baseline to Week 10
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Mean Change in Brief Visuospatial Memory Test
Time Frame: Baseline to week 23
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The 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.
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Baseline to week 23
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Mean Change in EPCCE Sum Score From Baseline to Week 4
Time Frame: Baseline to Week 4
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The 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.
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Baseline to Week 4
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Mean Change in EPCCE Sum Score From Baseline to Week 10
Time Frame: Baseline to Week 10
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The 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.
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Baseline to Week 10
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Mean Change in EPCCE Sum Score From Baseline to Week 23
Time Frame: Baseline to Week 23
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The 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.
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Baseline to Week 23
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Mean Change in UFOV Score From Baseline to Week 10
Time Frame: Baseline to Week 10
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The 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.
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Baseline to Week 10
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Mean Change in UFOV Score From Baseline to Week 23
Time Frame: Baseline to Week 23
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The 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.
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Baseline to Week 23
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Mean Change in Activities of Daily Living-Prevention Instrument
Time Frame: Baseline to week 23
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Mean 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.
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Baseline to week 23
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Anne Corriveau, PhD, University of Rochester
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00067091
- R21AG054810 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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