Clinical trial NCT03292705: Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment
Official title: Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: cognitive training
person-centered approach
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 49
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attitudes Toward Computers Questionnaire Total score
timeFrame: Baseline, End of Weeks 4, End of Week 10, & Week 23
measure: Useful Field of View
timeFrame: Baseline, End of Week 10, & Week 23
measure: Executive Function
timeFrame: Baseline, End of Weeks 4, End of Week 10, & Week 23
measure: Brief Visuospatial Memory Test
timeFrame: Baseline, End of Weeks 4, End of Week 10, & Week 23
Secondary outcomes:
measure: Activities of Daily Living-Prevention Instrument
timeFrame: Baseline, End of Weeks 4, End of Week 10, & Week 23
measure: Everyday Problems for Cognitive Challenged Elderly Test
timeFrame: Baseline, End of Weeks 4, End of Week 10, & Week 23
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Brickstone/Saint John Meadow
state: New York
city: Rochester
country: United States
facility: River Edge Manor
state: New York
Study officials:
affiliation: University of Rochester
name: Anne Corriveau, PhD
role: STUDY_DIRECTOR
References:
citation: 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.