BRAIN SAFE
K
Kristine Nanagas
Primary Investigator
R
Richard Holden
Primary Investigator
Overview
The Brain Safe study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults’ exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life, with the following hypotheses:
H1. Anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months.
H2. Older adults randomized to Brain Safe will have higher cognitive function, measured by using an objective, performance-based composite, compared to those randomized to the attention control app, at 12 months
H3. Older adults randomized to Brain Safe will have higher health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months
An exploratory aim of the study is to examine early effects of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months.
H1. Anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months.
H2. Older adults randomized to Brain Safe will have higher cognitive function, measured by using an objective, performance-based composite, compared to those randomized to the attention control app, at 12 months
H3. Older adults randomized to Brain Safe will have higher health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months
An exploratory aim of the study is to examine early effects of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Healthy
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Age: Between 60 Years - 100 Years
-
Gender: All
Inclusion Criteria
-At least 1 primary care visit in past 365 days to participating Eskenazi Health or IU Health primary care clinic
-Primary care appointment scheduled in next 15-90 days at participating Eskenazi Health or IU Health primary care clinic
-At least one anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3, dispensed in past 90 days
-English-speaking
-Community-dwelling in Central Indiana
-No cognitive impairing condition, as assessed by 6-item cognitive screener (see Notes and Attachments) and absence of ICD-9 and ICD-10 codes for mild cognitive impairment and Alzheimer's disease and related dementias, and serious mental illness
-No major visual impairment
-No terminal illness
-Primary care appointment scheduled in next 15-90 days at participating Eskenazi Health or IU Health primary care clinic
-At least one anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3, dispensed in past 90 days
-English-speaking
-Community-dwelling in Central Indiana
-No cognitive impairing condition, as assessed by 6-item cognitive screener (see Notes and Attachments) and absence of ICD-9 and ICD-10 codes for mild cognitive impairment and Alzheimer's disease and related dementias, and serious mental illness
-No major visual impairment
-No terminal illness
Updated on
07 May 2024.
Study ID: 1811254189
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