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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44AG076304 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this project is to further develop and evaluate a computerized cognitive-training program designed to extend older adults' functional independence and reduce accidental falls (i.e., reduce factors that contribute to fall risk; including cognitive abilities/executive functions). This intervention may benefit a large population of vulnerable older adults with elevated fall risk and lack of long-term viable treatment options.
The investigators will employ a single arm study open label usability/feasibility study comprised of a computerized training program that targets core executive functions (working memory, inhibition), speed of processing and sustained attention, and is grounded on design principles that drive adaptive brain plasticity to improve cognitive function and bolster functional abilities in older adults with an elevated fall risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive Training | Other | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. |
| Measure | Description | Time Frame |
|---|---|---|
| Net Promoter Score (NPS) | NPS (Net Promoter Score) is a whole number on a scale of -100 to +100, calculated by subtracting the percentage of Detractors from the percentage of Promoters. Promoters (score 9-10) are likely to exhibit value-creating behaviors, such as referring other potential program participants. Detractors (score 0-6) are less likely to do so. Passives (score 7-8) fall in between. Passives count toward the total number of respondents, which decreases the percentage of Promoters and Detractors and pushes the score toward 0. Higher score is better. | At 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Program Adoption Rate | Evaluating the adoption of the intervention program. | 10 weeks |
| Usability - Program Navigation - Platform is Accessible and Easy to Navigate | This is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Van Vleet, PhD | Posit Science Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Posit Science Corporation | San Francisco | California | 94111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Treatment | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Treatment | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. |
| 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, Categorical | Count of Participants |
| 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 | Net Promoter Score (NPS) | NPS (Net Promoter Score) is a whole number on a scale of -100 to +100, calculated by subtracting the percentage of Detractors from the percentage of Promoters. Promoters (score 9-10) are likely to exhibit value-creating behaviors, such as referring other potential program participants. Detractors (score 0-6) are less likely to do so. Passives (score 7-8) fall in between. Passives count toward the total number of respondents, which decreases the percentage of Promoters and Detractors and pushes the score toward 0. Higher score is better. | Posted | Mean | 95% Confidence Interval | score on a scale | At 10 weeks |
|
10 weeks
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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 | Experimental Treatment | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. Computerized Plasticity-Based Adaptive Cognitive Training: Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, ~30 minutes per session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tom Van Vleet | Posit Science Corporation | (415) 568-3562 | 119 | tom.vanvleet@positscience.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2022 | Oct 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2022 | Oct 16, 2025 | SAP_001.pdf |
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| 10 weeks |
| Usability - Perceived Benefits - Felt Program Was Therapeutic | This is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better. | 10 weeks |
| Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living | This is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better. | 10 weeks |
| Program Training Levels Completed | Engagement with the program was evaluated based on the total number of training levels completed. Intended Range: 0-500 levels. Actual range: 441-777 levels. Higher number is better. | 10 weeks |
| The Activities-specific Balance Confidence (ABC) Scale | This is a 16-item self-report questionnaire to assess confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Scoring range is 0% to 100% confidence scale where a score of 0% means no confidence while 100% indicates complete confidence. Higher score is better. | 10 weeks |
| Activity Measure for Post-Acute Care (AM-PAC) | This scale is an 18-item validated patient-reported outcome measure designed to assess functional abilities across multiple domains, including basic mobility, daily activities, and applied cognitive functioning. The AM-PAC uses a T-score metric, standardized with a mean of 50 and a standard deviation of 10, to reflect mobility function. Higher T-scores reflect better mobility. | 10 weeks |
| Brief Pain Inventory (BPI) - Pain Severity Subscale | This is an 11-item self-report questionnaire assessing current pain intensity and the degree to which pain interferes with daily life. The Pain Severity Subscale contains 4 items; scores are summed and divided by 4, yielding a range of 0 (No pain) to 10 (Pain as bad as you can imagine). Higher scores indicate greater severity. | 10 weeks |
| Falls Calendar - Self-reported Falls | Total number of self-reported falls. A falls calendar questionnaire was administered weekly to inquire about recent falls and/or if the participant had tripped or lost balance without falling each week during the study. Lower number is better; indicating fewer falls reported. | 10 weeks |
| Falls Calendar - Self-reported Loss of Balance | Total number of self-reported loss of balance/trips. A falls calendar questionnaire was administered weekly to inquire about recent falls and/or if the participant had tripped or lost balance without falling each week during the study. Lower number is better; indicating fewer instances of loss of balance/trips. | 10 weeks |
| Falls Detection | A spontaneous fall detection utility embedded in the Apple watch. | 10 weeks |
| Gait Speed Score | Gait speed is measured through a self-administered, telehealth coach-supported 60-second Gait App test at baseline and after program use. This assessment requires an iPhone or iPod Touch. The metric captures the time (in seconds) elapsed between the first contact of two consecutive footsteps of the same foot. A lower score reflects faster gait speed, which indicates better performance. | 10 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Program Adoption Rate | Evaluating the adoption of the intervention program. | One participant could not commit to the amount of time required to use the program. | Posted | Number | participants | 10 weeks |
|
|
|
| Secondary | Usability - Program Navigation - Platform is Accessible and Easy to Navigate | This is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| Secondary | Usability - Perceived Benefits - Felt Program Was Therapeutic | This is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| Secondary | Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living | This is a brief and embedded post-study questionnaire on program navigation, perceived benefits, and whether the program helped participants to make a positive change in their activities of daily living. Participants rate each sentence on the following 7-point Likert scale: 1 =Completely Disagree; 2 = Mostly Disagree; 3 = Somewhat Disagree; 4 = Undecided; 5 = Somewhat Agree; 6 = Mostly Agree; 7 = Completely Agree. Scoring range: 1-7; higher score is better. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| Secondary | Program Training Levels Completed | Engagement with the program was evaluated based on the total number of training levels completed. Intended Range: 0-500 levels. Actual range: 441-777 levels. Higher number is better. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| Secondary | The Activities-specific Balance Confidence (ABC) Scale | This is a 16-item self-report questionnaire to assess confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Scoring range is 0% to 100% confidence scale where a score of 0% means no confidence while 100% indicates complete confidence. Higher score is better. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| Secondary | Activity Measure for Post-Acute Care (AM-PAC) | This scale is an 18-item validated patient-reported outcome measure designed to assess functional abilities across multiple domains, including basic mobility, daily activities, and applied cognitive functioning. The AM-PAC uses a T-score metric, standardized with a mean of 50 and a standard deviation of 10, to reflect mobility function. Higher T-scores reflect better mobility. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
|
| Secondary | Brief Pain Inventory (BPI) - Pain Severity Subscale | This is an 11-item self-report questionnaire assessing current pain intensity and the degree to which pain interferes with daily life. The Pain Severity Subscale contains 4 items; scores are summed and divided by 4, yielding a range of 0 (No pain) to 10 (Pain as bad as you can imagine). Higher scores indicate greater severity. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
|
|
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| Secondary | Falls Calendar - Self-reported Falls | Total number of self-reported falls. A falls calendar questionnaire was administered weekly to inquire about recent falls and/or if the participant had tripped or lost balance without falling each week during the study. Lower number is better; indicating fewer falls reported. | Posted | Number | number of falls | 10 weeks |
|
|
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| Secondary | Falls Calendar - Self-reported Loss of Balance | Total number of self-reported loss of balance/trips. A falls calendar questionnaire was administered weekly to inquire about recent falls and/or if the participant had tripped or lost balance without falling each week during the study. Lower number is better; indicating fewer instances of loss of balance/trips. | Posted | Number | instances | 10 weeks |
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| Secondary | Falls Detection | A spontaneous fall detection utility embedded in the Apple watch. | Posted | Number | number of falls detected | 10 weeks |
|
|
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| Secondary | Gait Speed Score | Gait speed is measured through a self-administered, telehealth coach-supported 60-second Gait App test at baseline and after program use. This assessment requires an iPhone or iPod Touch. The metric captures the time (in seconds) elapsed between the first contact of two consecutive footsteps of the same foot. A lower score reflects faster gait speed, which indicates better performance. | Posted | Mean | Standard Deviation | seconds | 10 weeks |
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| 23 |
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