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

Mild Cognitive Impairment Clinical Trial

— CogT-PACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292705
• Other study ID #: R21AG054810
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 1, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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. 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
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.

Locations

Country	Name	City	State
United States	Brickstone/Saint John Meadow	Rochester	New York
United States	River Edge Manor	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitudes Toward Computers Questionnaire Total score	change of attitudes towards technology across time points	Baseline, End of Weeks 4, End of Week 10, & Week 23
Primary	Useful Field of View	change of visual speed of processing and attention across time points	Baseline, End of Week 10, & Week 23
Primary	Executive Function	change of executive function across time points	Baseline, End of Weeks 4, End of Week 10, & Week 23
Primary	Brief Visuospatial Memory Test	change of visuospatial memory across time points	Baseline, End of Weeks 4, End of Week 10, & Week 23
Secondary	Activities of Daily Living-Prevention Instrument	change of self-perceived functioning in daily living activities across time points	Baseline, End of Weeks 4, End of Week 10, & Week 23
Secondary	Everyday Problems for Cognitive Challenged Elderly Test	change of objective functioning in daily living activities across time points	Baseline, End of Weeks 4, End of Week 10, & Week 23