Aging, Cognitive Change
Conditions
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.
Interventions
BEHAVIORALAdaptive 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).
BEHAVIORALActive 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
Sponsors
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Attempted to Complete the Adaptive Cognitive Evaluation (ACE) From Baseline at 6 Weeks | 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 and (2) Working memory in the ACE software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Performance on the Everyday Cognition Scale (ECog) From Baseline at 6 Weeks | 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. |
| Mean Change on Cognitive Failures Questionnaire (CFQ) From Baseline at 6 Weeks | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 6 |
| 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.
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 | 0 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | The COVID pandemic devastated this study, as Brookdale efforts focused on resident health and safety | 6 | 0 |
Baseline characteristics
| Characteristic | Active Control Group | Adaptive Cognitive Control Trainer (ACCT) | Total |
|---|---|---|---|
| ACE-X CPT- | 0 Participants | 6 Participants | 6 Participants |
| ACE-X Spatial Span | 0 Participants | 6 Participants | 6 Participants |
| Age, Continuous | — | 72 years STANDARD_DEVIATION 5.5 | 72 years STANDARD_DEVIATION 5.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | — | 2 Participants | 2 Participants |
| Sex: Female, Male Male | — | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 0 |
| other Total, other adverse events | 0 / 12 | 0 / 0 |
| serious Total, serious adverse events | 0 / 12 | 0 / 0 |
Outcome results
Primary
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.
Time frame: At Baseline and post intervention at the 6 week mark
Population: Individuals from Brookdale Senior Living Communities from across U.S. We counted How Many participants attempted to complete the ACE-X battery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adaptive Cognitive Control Trainer (ACCT) | Number of Participants Who Attempted to Complete the Adaptive Cognitive Evaluation (ACE) From Baseline at 6 Weeks | 6 Participants |
| Active Control Group | Number of Participants Who Attempted to Complete the Adaptive Cognitive Evaluation (ACE) From Baseline at 6 Weeks | 0 Participants |
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.
Time frame: At Baseline and post intervention at the 6 week mark
Population: No data was collected in the end for this measure, as no participants completed this measure.
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.
Time frame: At Baseline and post intervention at the 6 week mark
Population: Note that no data was collected for this measure, as none of the participants completed this requested survey.
Secondary
Mean Performance on the 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.
Time frame: At Baseline and post intervention at the 6 week mark
Population: This measure was not collected in the end; none of the participants completed this measurement