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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04905849
Other study ID # R21AG058896
Secondary ID R21AG058896
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date December 1, 2022

Study information

Verified date September 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to test the feasibility of launching a personalized digital health assessment and remediation program for the older adults in senior living communities based upon an initial characterization of these abilities. Evidence of feasibility here using these unique methodological approaches would provide empirical evidence supporting the basis for a larger-scale implementation of such digital health technologies into less controlled senior settings.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Must be living at a Senior Living Community - have own iPad and/or smartphone, - native-English speaker. Participation across a spectrum of cognitive abilities is desired for this study, specifically for older adults in a community setting. Exclusion Criteria: - Do not have any physical or cognitive limitations that would clearly prevent them from utilizing these applications as intended

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adaptive Cognitive Control Trainer (ACCT)
Module 1: Attention=> This module demands an active scan of the screen in search for a target, much like traditional visual search tasks. Participants quickly identify the direction that a probe target is facing (up, down, left, right), and are aided by the presence of directional cue indicating where the location of the target will appear. Module 2: Goal Management=> Requires participants to rapidly switch their focus based on distinct rules. Participants are presented with exemplar objects along with a target, and are asked to indicate which exemplar presented is most like the target. Module 3: Working Memory=> Engages spatial working memory resources similar to the Corsi block task. Participants memorize the location of objects on screen followed by a 5-7 second delay period, with a correct response leading to a greater number of potential targets to be memorized on the next trial (and vice versa).
Active Control App
The app used here is undergoing expectancy-matching at the present time, will be updated with the final app characteristics when completed out of a list of several possibilities

Locations

Country Name City State
United States UC San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change on Adaptive Cognitive Evaluation (ACE) from Baseline at 6 weeks ACE is a custom mobile cognitive health assessment battery that presents paradigms typically used in standard cognitive neuroscience laboratories. Here the investigators will assess a measure of (1) Attention (2) Working memory, and (3) Goal management in the ACE software. We will assess response time, accuracy, and response time variability in each case, with faster/more accurate/less variable performance being indicative of improved cognitive control. At Baseline and post intervention at the 6 week mark
Secondary Mean Change on Everyday Cognition Scale (ECog) from Baseline at 6 weeks The Everyday Cognition Scale (ECog) measures the ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, organization, and divided attention. The ECog consists of a global and domain scores for each of the previously described categories, and is scored as follows: 1= better or no change compared to 10 years earlier, 2= questionable/occasionally worse compared to 10 years earlier, 3= consistently a little worse compared to 10 years earlier, 4= consistently much worse compared to 10 years earlier. Thus, the lower the overall score is on this measure at both the global and domain score level, the better one is performing with respect to their cognition. At Baseline and post intervention at the 6 week mark
Secondary Mean Change on Cognitive Failures Questionnaire (CFQ) from Baseline at 6 weeks The Cognitive Failures Questionnaire (CFQ) assesses participant distractibility. The CFQ score ranges from 0 to 100, with the lower the overall score is on this measure, the better one is performing with respect to their cognition. At Baseline and post intervention at the 6 week mark
Secondary Mean Change on General health and well-being (SF-36) from Baseline at 6 weeks The general health and well-being (SF-36) score assesses participant health. The SF-36 score ranges from 0 to 100. The higher the overall score is on this measure, the better one is performing with respect to their health and well-being. At Baseline and post intervention at the 6 week mark
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