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Mild Cognitive ImpairmentCogT-PACTNCT03292705

Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment

A study testing PEP and CCI in people with Mild Cognitive Impairment, run by University of Rochester at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Computerized cognitive interventions (CCIs) have been increasingly widely implemented among older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in maintaining or improving older adults' cognitive and functional health has been modest and highly variable. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
PEP and CCI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesUnited States
Study dates
1 Oct 2017to 1 Sep 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • English-speaking
  • adequate visual and hearing acuity for testing
  • intact decision making capacity.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Brickstone/Saint John Meadow

    Rochester, New York, 14618

  • River Edge Manor

    Rochester, New York, 14642

Other trials in United States

About this study

Computerized cognitive interventions (CCIs) have been increasingly widely implemented among older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in maintaining or improving older adults' cognitive and functional health has been modest and highly variable. Older individuals' attitudes toward technology use may help explain some of the variability in CCI effects. The goal of this R21 is to generate proof-of-concept for an intervention that may improve attitudes toward computers among those with MCI, in turn improving engagement with and efficacy of a subsequent CCI. Person-centered care-that is, integrating individuals' preferences throughout the process of intervention--has improved intervention engagement among older persons, including those with MCI. A recent intervention predicated on this person-centered approach is called "personalized engagement program" (PEP). PEP involves a database of individualized computer-led leisure activities. The investigators' recent pilot data in senior living facilities suggest that PEP promotes psychological well-being among older persons with MCI, and may shift computers from dauntingly complex or personally irrelevant devices to familiar, enjoyable technology. These results are consistent with a number of theories indicating that exposure to pleasurable experiences with an object or task improves several dimensions of attitudes, including affective and cognitive components, as well as behavior and motivation. Grounded in both this pilot data and the theory around it, the investigators seek to take the next step in an arc of research ultimately intended to improve the efficacy of CCIs. A small randomized controlled trial (RCT) is proposed to assess whether an initial period of PEP, followed by a standard CCI, improves a) attitudes toward computers, b) engagement with the CCI, and c) cognitive outcomes, compared to an attention control period followed by CCI. Our design involving stratified random assignment of 50 assisted living residents with MCI from 4 senior living facilities to these two groups. The initial phase involves 4 weeks of either attention control or PEP, a "dose" suggested by prior work on attitude change and computers, followed by 6 weeks of CCI for both groups (a period our prior work indicates is sufficient for change in key cognitive domains among this population). This application is the first of which we are aware striving to augment CCIs, which are now ubiquitous, by addressing an attitudinal or affective element of the person, which are often ignored in the cognitive intervention literature. The adjuvant of PEP also answers increasing calls for "personalized" or "person-centered" behavioral interventions with older persons.

Being tested
PEP, CCI
Keywords
cognitive training, person-centered approach
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEPBehavioural

    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.

  • CCIBehavioural

    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.

Study groups in NCT03292705
Study groupRoleWhat they receive
PEP+CCIExperimentalPEP: 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.
Receives: Behavioral: PEP; Behavioral: CCI
control+CCIActive comparatorFor 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.
Receives: Behavioral: CCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in ADL Score From Baseline to Week 10

    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.

    Measured: Baseline to Week 10

  2. Mean Change in ADL Score From Baseline to Week 23

    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.

    Measured: Baseline to Week 23

  3. Mean Executive Function Measured by Examiner

    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.

    Measured: Baseline to week 4

  4. Mean Executive Function Measured by Examiner

    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.

    Measured: Baseline to End of Week 10 Evaluation

  5. Mean Executive Function Measured by Examiner

    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.

    Measured: Baseline to End of 23 Weeks

Secondary outcomes (12)
  1. Mean Change in Attitudes Toward Computers Questionnaire

    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.

    Measured: Baseline to week 4

  2. Mean Change in Attitudes Toward Computers Questionnaire

    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.

    Measured: Baseline to End of Week 10 Evaluation

  3. Mean Change in Attitudes Toward Computers Questionnaire

    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.

    Measured: Baseline to End of 23 Weeks

  4. Mean Change in Brief Visuospatial Memory Test

    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.

    Measured: Baseline to Week 4

  5. Mean Change in Brief Visuospatial Memory Test

    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.

    Measured: Baseline to Week 10

  6. Mean Change in Brief Visuospatial Memory Test

    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.

    Measured: Baseline to week 23

  7. Mean Change in EPCCE Sum Score From Baseline to Week 4

    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.

    Measured: Baseline to Week 4

  8. Mean Change in EPCCE Sum Score From Baseline to Week 10

    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.

    Measured: Baseline to Week 10

  9. Mean Change in EPCCE Sum Score From Baseline to Week 23

    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.

    Measured: Baseline to Week 23

  10. Mean Change in UFOV Score From Baseline to Week 10

    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.

    Measured: Baseline to Week 10

  11. Mean Change in UFOV Score From Baseline to Week 23

    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.

    Measured: Baseline to Week 23

  12. Mean Change in Activities of Daily Living-Prevention Instrument

    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.

    Measured: Baseline to week 23

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start1 Oct 2017
  3. Primary completion5 Apr 2019
  4. Study completion1 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single-blinded, multi-site (4 SLCs) randomized controlled trial of PEP+CCI, vs. control + CCI is involved. For PEP+CCI group, PEP will be implemented for the first 4 weeks, and CCI for the following 6 weeks. 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. Assessments will be conducted by our research team. Separate staff blind to group assignment will conduct post-training and follow-up assessments. All intervention and assessments will occur in private rooms in relevant SLCs.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292705
Sponsor's protocol ID
STUDY00067091
Other IDs
R21AG054810
Acronym
CogT-PACT
Status last verified
Feb 2026
First submitted
20 Sep 2017
Last updated
20 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lin FV, Cottone K, Mcdermott K, Jacobs A, Nelson D, Porsteinsson A, Chapman BP. Attitudes Toward Computers Moderate the Effect of Computerized Cognitive Trainings in Oldest-Old Senior Living Center Residents. Am J Geriatr Psychiatry. 2021 Mar;29(3):285-294. doi: 10.1016/j.jagp.2020.07.001. Epub 2020 Jul 7.

    PubMed 32739240

Questions about this trial

What is this clinical trial studying?

A study testing PEP and CCI in people with Mild Cognitive Impairment, run by University of Rochester at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in ADL Score From Baseline to Week 10 (time frame: Baseline to Week 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03292705, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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