We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community (Senior Living)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04905849
Recruitment Status : Active, not recruiting
First Posted : May 28, 2021
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Aging Cognitive Change Behavioral: Adaptive Cognitive Control Trainer (ACCT) Behavioral: Active Control App Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Adaptive Cognitive Control Trainer (ACCT)
There are three modules within the game, each training a different aspect of cognitive control (attention, goal management, working memory): a visual search task for attention abilities, a spatial span task for working memory, and a task switching paradigm for goal management abilities. There are also 3 different levels of difficulty associated with each module; advancing to the next level delivers an advanced challenge that enhances the difficulty in performing the given cognitive task. Participants advance to the next level of difficulty following 6 training sessions occurring over 2 weeks, with the total training experience being 6 weeks of training (3 days/week), with each training session lasting 36 minutes (not including self-paced breaks).
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 Comparator: Active Control Group
An active control application will be used for this arm. The total training experience here will also be for 6 weeks (3 days/week), with each training session lasting ~30 minutes (not including self-paced breaks). Here an app that is matched in terms of expectancy of benefits compared to our training groups will be determined by questioning 100 naïve individuals to predict their expected improvement on each cognitive domain across a multitude of possible applications.
Behavioral: 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




Primary Outcome Measures :
  1. Mean Change on Adaptive Cognitive Evaluation (ACE) from Baseline at 6 weeks [ Time Frame: At Baseline and post intervention at the 6 week mark ]
    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.


Secondary Outcome Measures :
  1. Mean Change on Everyday Cognition Scale (ECog) from Baseline at 6 weeks [ Time Frame: At Baseline and post intervention at the 6 week mark ]
    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.

  2. Mean Change on Cognitive Failures Questionnaire (CFQ) from Baseline at 6 weeks [ Time Frame: At Baseline and post intervention at the 6 week mark ]
    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.

  3. Mean Change on General health and well-being (SF-36) from Baseline at 6 weeks [ Time Frame: At Baseline and post intervention at the 6 week mark ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905849


Locations
Layout table for location information
United States, California
UC San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Joaquin Anguera, Ph.D. UC San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04905849    
Other Study ID Numbers: R21AG058896 ( U.S. NIH Grant/Contract )
R21AG058896 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No