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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: PEP; Behavioral: CCI

• Registration Number: NCT03292705
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2017-10-01
• Primary Completion: 2019-04-05
• Study Completion: 2019-09-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP+CCI	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.
control+CCI	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.
PEP+CCI	PEP	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.

Primary Outcome Measures

Name	Time	Method
Executive Function	Baseline, End of Weeks 4, End of Week 10, & Week 23	change of executive function across time points
Brief Visuospatial Memory Test	Baseline, End of Weeks 4, End of Week 10, & Week 23	change of visuospatial memory across time points
Useful Field of View	Baseline, End of Week 10, & Week 23	change of visual speed of processing and attention across time points
Attitudes Toward Computers Questionnaire Total score	Baseline, End of Weeks 4, End of Week 10, & Week 23	change of attitudes towards technology across time points

Secondary Outcome Measures

Name	Time	Method
Activities of Daily Living-Prevention Instrument	Baseline, End of Weeks 4, End of Week 10, & Week 23	change of self-perceived functioning in daily living activities across time points
Everyday Problems for Cognitive Challenged Elderly Test	Baseline, End of Weeks 4, End of Week 10, & Week 23	change of objective functioning in daily living activities across time points

Trial Locations

Locations (2)

Brickstone/Saint John Meadow; 🇺🇸 Rochester, New York, United States

River Edge Manor; 🇺🇸 Rochester, New York, United States