Community-based Brain Health Program to Address Dementia Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Posit Science Corporation
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Net Promoter Score
Study Overview
Brief Summary
This is a validation study to evaluate the acceptability, feasibility and preliminary efficacy of the Brain Health Program, a multimodal curriculum covering dementia risk factors and evidence-based change interventions. The goal of this study is to evaluate the Brain Health Program in individuals with identified risk factors for the onset of dementia and to prepare for a large-scale efficacy trial in this population.
Detailed Description
This study will employ an evidence-based Brain Health Program curriculum, which involves a twelve-week, group-administered, personalized program designed to improve brain health in individuals with identified risk factors for the onset of dementia. This is a single-arm open-label feasibility study, enrolling older adults with Alzheimer's disease risk factors in a public health, community-deployed, group-based and individualized multimodal Brain Health Program (targeting, among other domains, diet, exercise and cognitive exercise), with a set of baseline assessments intended to characterize the population, and outcome measure to evaluate the usability of the program, as well as preliminary efficacy to reduce dementia risk factors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who are 65 years of age or older.
- •Participants who meet criteria for one or more ADRD dementia risk factors
- •Family history of Alzheimer's dementia (1st degree relative)
- •Genetic marker (APOE4++)
- •Subjective or objective cognitive decline (neuropsychological testing; or self-reported "yes" to the following question: "In the past two years, have you experienced a decline in your memory or thinking?"
- •Poorly controlled hypertension or diabetes
- •Physical inactivity <150min/week per Surgeon General guidelines
- •Social isolation, in which participant rarely or never gets social and emotional support when needed
- •Participants who are fluent English or Spanish speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
- •Participants have access to an internet accessible device (eg. laptop, desktop computer, tablet or smartphone)
- •Participants are able to attend all 12 classes (once a week for 12 weeks) and make up missed classes, as needed
- •Participants are able to travel to/from YMCA location, if they choose to be a part of the in-person group
Exclusion Criteria
- •Inability to provide informed consent
- •Cognitive Abilities Screening Instrument - Short (CASI-Short) scores ≤ 25 (suggestive of cognitive impairment)
- •Participants with untreated psychiatric conditions, including substance abuse/dependence disorders.
- •Participants enrolled in a concurrent clinical trial involving an 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.
- •Participants presently attending classes or courses like this program that is focused on dementia risk and behavior management.
Arms & Interventions
Brain Health Program
A multimodal educational and interactive diet, exercise and computerized cognitive exercise public health program.
Intervention: Brain Health Program (Other)
Outcomes
Primary Outcomes
Net Promoter Score
Time Frame: At 12 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 Outcomes
- Percentage of Participants Who Complete at 80% of Intended Program Sessions.(At 12 weeks)
- Program Comprehension(At 12 weeks)
- Relevancy of Program(At 12 weeks)
- Program Awareness(At 12 weeks)
- Program Work Assignments(At 12 weeks)
- Positive Lifestyle Change Post-program(At 12 weeks)
- Program Satisfaction(At 12 weeks)