NCT04905849

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

May 24, 2021

Results QC Date

December 1, 2023

Last Update Submit

June 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Attempted to Complete the 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 and (2) Working memory in the ACE software.

    At Baseline and post intervention at the 6 week mark

Secondary Outcomes (3)

  • Mean Performance on the Everyday Cognition Scale (ECog) From Baseline at 6 Weeks

    At Baseline and post intervention at the 6 week mark

  • Mean Change on Cognitive Failures Questionnaire (CFQ) From Baseline at 6 Weeks

    At Baseline and post intervention at the 6 week mark

  • Mean Change on General Health and Well-being (SF-36) From Baseline at 6 Weeks

    At Baseline and post intervention at the 6 week mark

Study Arms (2)

Adaptive Cognitive Control Trainer (ACCT)

EXPERIMENTAL

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)

Active Control Group

ACTIVE COMPARATOR

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

Interventions

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).

Adaptive Cognitive Control Trainer (ACCT)

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

Active Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Do not have any physical or cognitive limitations that would clearly prevent them from utilizing these applications as intended

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Francisco

San Francisco, California, 94158, United States

Location

Limitations and Caveats

The primary limitation was the onset of COVID pandemic, which prevented the study from being completed entirely, in any way, like the originally designed study. This restricted the amount, quality, and extent of data collected. Our partners at Brookdale acknowledged that they would not be able to contribute to this project as desired as "we're trying to keep our seniors alive right now, and do not have the bandwidth to help with any other endeavors"

Results Point of Contact

Title
Dr. Joaquin A. Anguera, Associate Professor
Organization
UC San Francisco

Study Officials

  • Joaquin Anguera, Ph.D.

    UC San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 28, 2021

Study Start

May 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

July 3, 2025

Results First Posted

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations