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

NCT03292705 | Completed Results

• 2 other identifiers: STUDY00067091R21AG054810
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Keywords

cognitive training; person-centered approach

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline to Week 10

• 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.

  Baseline to Week 23

• 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.

  Baseline to week 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.

  Baseline to End of Week 10 Evaluation

• 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.

  Baseline to End of 23 Weeks

Secondary Outcomes (12)

• Mean Change in Attitudes Toward Computers Questionnaire

  Baseline to week 4

• Mean Change in Attitudes Toward Computers Questionnaire

  Baseline to End of Week 10 Evaluation

• Mean Change in Attitudes Toward Computers Questionnaire

  Baseline to End of 23 Weeks

• Mean Change in Brief Visuospatial Memory Test

  Baseline to Week 4

• Mean Change in Brief Visuospatial Memory Test

  Baseline to Week 10

Study Arms (2)

PEP+CCI

EXPERIMENTAL

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.

Behavioral: PEP; Behavioral: CCI

control+CCI

ACTIVE COMPARATOR

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.

Behavioral: CCI

Interventions

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.

PEP+CCI

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.

PEP+CCI; control+CCI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Brickstone/Saint John Meadow

Rochester, New York, 14618, United States

Location

River Edge Manor

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 32739240 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Vankee Lin
• Organization: University of Rochester

vankee_lin@urmc.rochester.edu

(585) 276-6002

Study Officials

• Anne Corriveau, PhD

  University of Rochester

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to the group assignment. The participants will be informed to avoid discussing their intervention activities at the post-training and follow up assessments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: October 1, 2017
• Primary Completion: April 5, 2019
• Study Completion: September 1, 2019
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Locations

US (2)