Status:
COMPLETED
Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one...
Detailed Description
This 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 s...
Eligibility Criteria
Inclusion
- ≥ 1 primary care visit at Eskenazi Health or IU Health in past 12 months
- Age ≥ 60 years
- Written informed consent and HIPAA authorization for the release of personal health information.
- English-speaking
- At least one prescription for a strong anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, and currently using it
- Community-dwelling in Central Indiana
- Not cognitively impaired
- Not terminally ill
- Not sensory impaired (after correction)
Exclusion
- Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications.
- Diagnosis of Alzheimer's disease or related dementia (ADRD), determined by International Classification of Diseases (ICD)-9/ICD-10 codes or current use of a medication for ADRD
- Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by ICD-9/ICD-10 codes
- Involvement in another clinical trial that would prevent or interfere with study objectives
- Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
- Not currently using anticholinergic medication
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
706 Patients enrolled
Trial Details
Trial ID
NCT04121858
Start Date
October 16 2019
End Date
February 27 2025
Last Update
March 13 2025
Active Locations (2)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
IU Health
Indianapolis, Indiana, United States, 46202