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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEP
CCI
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring cognitive training, person-centered approach

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brickstone/Saint John Meadow
  • River Edge Manor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEP+CCI

control+CCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Attitudes Toward Computers Questionnaire Total score
change of attitudes towards technology across time points
Useful Field of View
change of visual speed of processing and attention across time points
Executive Function
change of executive function across time points
Brief Visuospatial Memory Test
change of visuospatial memory across time points

Secondary Outcome Measures

Activities of Daily Living-Prevention Instrument
change of self-perceived functioning in daily living activities across time points
Everyday Problems for Cognitive Challenged Elderly Test
change of objective functioning in daily living activities across time points

Full Information

First Posted
September 20, 2017
Last Updated
December 5, 2019
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03292705
Brief Title
Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment
Acronym
CogT-PACT
Official Title
Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
cognitive training, person-centered approach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP+CCI
Arm Type
Experimental
Arm Description
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.
Arm Title
control+CCI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PEP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CCI
Intervention Description
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 Outcome Measure Information:
Title
Attitudes Toward Computers Questionnaire Total score
Description
change of attitudes towards technology across time points
Time Frame
Baseline, End of Weeks 4, End of Week 10, & Week 23
Title
Useful Field of View
Description
change of visual speed of processing and attention across time points
Time Frame
Baseline, End of Week 10, & Week 23
Title
Executive Function
Description
change of executive function across time points
Time Frame
Baseline, End of Weeks 4, End of Week 10, & Week 23
Title
Brief Visuospatial Memory Test
Description
change of visuospatial memory across time points
Time Frame
Baseline, End of Weeks 4, End of Week 10, & Week 23
Secondary Outcome Measure Information:
Title
Activities of Daily Living-Prevention Instrument
Description
change of self-perceived functioning in daily living activities across time points
Time Frame
Baseline, End of Weeks 4, End of Week 10, & Week 23
Title
Everyday Problems for Cognitive Challenged Elderly Test
Description
change of objective functioning in daily living activities across time points
Time Frame
Baseline, End of Weeks 4, End of Week 10, & Week 23

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Corriveau, PhD
Organizational Affiliation
University of Rochester
Official's Role
Study Director
Facility Information:
Facility Name
Brickstone/Saint John Meadow
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
River Edge Manor
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32739240
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.
Results Reference
derived

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

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