Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk

Posit Science Corporation32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fall

Interventions

Computerized Plasticity-Based Adaptive Cognitive TrainingOTHER

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, 5 sessions per week, \~30 minutes per session.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Posit Science Corporation

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: At 10 weeks

Secondary Outcomes

Program Adoption Rate

Evaluating the adoption of the intervention program.

Time frame: 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.

Time frame: 10 weeks

Usability - Perceived Benefits - Felt Program Was Therapeutic

Time frame: 10 weeks

Usability - Whether the Program Helped Participants Make a Positive Change in Their Activities of Daily Living

Data from ClinicalTrials.gov

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