Fall
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.
Sponsors
Posit Science Corporation
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who are 65 years of age or older. 2. Participants must be US residents. 3. Participant with at least one self-reported fall within the last 1 year or difficulty walking one half a mile or difficulty climbing one flight of stairs. 4. Participants who are fluent English speakers from the age of 12, per self-report, to ensure reasonable neuropsychological results on key assessments. 5. Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet.
Exclusion criteria
1. Participants had joint replacement surgery or significant join/leg injury less than one year prior to the screening visit. 2. Participants have a joint replacement surgery scheduled within the next 6 months. 3. Participants use a walker or wheelchair on a regular basis. 4. Participants have a diagnosis of benign paroxysmal positional vertigo (BPPV), labyrinthitis or suffers migraines that result in chronic vertigo. 5. Participants self-reports vision or hearing difficulties that would interfere with the ability to complete the study tasks. 6. Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, recent hospitalization, ongoing chemotherapy or other cancer treatment. 7. Participants with medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline (e.g. multiple sclerosis, stroke, traumatic brain injury, dementia, etc.) 8. Participants enrolled in a concurrent clinical trial involving an intervention targeting physical functioning to prevent falls; investigational pharmaceutical; nutraceutical; medical device; or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable. 9. Participants using computer-based cognitive training programs or has used it within a month of the consent date. 10. Participants who answered 'yes' to questions 4 (Active Suicidal Ideation with Intent) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" if the ideation or behavior occurred within 2 months from Participant's date of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Promoter Score (NPS) | At 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Program Adoption Rate | 10 weeks | Evaluating the adoption of the intervention program. |
| Usability - Program Navigation - Platform is Accessible and Easy to Navigate | 10 weeks | 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. |
| Usability - Perceived Benefits - Felt Program Was Therapeutic | 10 weeks | 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. |
| Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living | 10 weeks | 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. |
| Program Training Levels Completed | 10 weeks | 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. |
| The Activities-specific Balance Confidence (ABC) Scale | 10 weeks | 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. |
| Activity Measure for Post-Acute Care (AM-PAC) | 10 weeks | 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. |
| Brief Pain Inventory (BPI) - Pain Severity Subscale | 10 weeks | 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. |
| Falls Calendar - Self-reported Falls | 10 weeks | 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. |
| Falls Calendar - Self-reported Loss of Balance | 10 weeks | 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. |
| Falls Detection | 10 weeks | A spontaneous fall detection utility embedded in the Apple watch. |
| Gait Speed Score | 10 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Van Vleet, PhD
Posit Science Corporation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
None listed