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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG058896 | U.S. NIH Grant/Contract | View source |
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COVID-19 pandemic prevented the participating senior centers from recruiting as originally stipulated
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Cognitive Control Trainer (ACCT) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Participation across a spectrum of cognitive abilities is desired for this study, specifically for older adults in a community setting.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Anguera, Ph.D. | UC San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Francisco | San Francisco | California | 94158 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants from different Brookdale Senior Living Communities across the United States
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Individuals from Brookdale Senior Living Communities from across U.S. We counted How Many participants attempted to complete the ACE-X battery. | Posted | Count of Participants | Participants | At Baseline and post intervention at the 6 week mark |
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The time frame was over the course of the study (e.g. 1 year) Note that the study took place over a 6 week period, with 1 week given as a window to complete each assessment period Baseline -> 4 week intervention -> Post-training Assessment This was the time period over which adverse event data were collected
We used the same definition used by clinicaltrials.gov. Participants were asked to self-report any adverse events over the course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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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"
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joaquin A. Anguera, Associate Professor | UC San Francisco | 415 502 7322 | joaquin.anguera@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2018 | Nov 28, 2023 | Prot_SAP_000.pdf |
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| Active Control App | Behavioral | 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 |
|
| At Baseline and post intervention at the 6 week mark |
| 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 |
| 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| ACE-X | ACE-X is an iOS app measuring cognitive control, specifically attention and working memory abilities including a version of a Continuous Performance Task (CPT) and a foward/backward spatial span task (Corsi Block). For the CPT like task, the measure of interest per participant was mean accuracy (% of trials that were correctly responded to) and response time variability (the variance associated with response time). For the Span tasks, the measure of interest was the maximum length of the span achieved. Here our goal was to measure HOW MANY participants were able to complete the ACE-X tasks. | Count of Participants | Participants |
|
| OG001 | 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 |
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| 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. | This measure was not collected in the end; none of the participants completed this measurement | Posted | At Baseline and post intervention at the 6 week mark | survey count | survey count |
|
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| 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. | No data was collected in the end for this measure, as no participants completed this measure. | Posted | At Baseline and post intervention at the 6 week mark |
|
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| 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. | Note that no data was collected for this measure, as none of the participants completed this requested survey. | Posted | At Baseline and post intervention at the 6 week mark |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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