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Completed

NCT Number: NCT03292705

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brickstone/Saint John Meadow, Rochester, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP

Behavioral

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.

CCI

Behavioral

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Mean Executive Function Measured by Examiner

    Time frame: Baseline to week 4

    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.

  4. Mean Executive Function Measured by Examiner

    Time frame: Baseline to End of Week 10 Evaluation

    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.

  5. Mean Executive Function Measured by Examiner

    Time frame: Baseline to End of 23 Weeks

    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.

Secondary outcomes

  1. Mean Change in Attitudes Toward Computers Questionnaire

    Time frame: Baseline to week 4

    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.

  2. Mean Change in Attitudes Toward Computers Questionnaire

    Time frame: Baseline to End of Week 10 Evaluation

    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.

  3. Mean Change in Attitudes Toward Computers Questionnaire

    Time frame: Baseline to End of 23 Weeks

    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.

  4. Mean Change in Brief Visuospatial Memory Test

    Time frame: Baseline to Week 4

    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.

  5. Mean Change in Brief Visuospatial Memory Test

    Time frame: Baseline to Week 10

    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.

  6. Mean Change in Brief Visuospatial Memory Test

    Time frame: Baseline to week 23

    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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Baseline to week 23

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: CogT-PACT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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