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Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease

CompletedNA

Sponsor: Indiana University

Conditions: Alzheimer Disease, Dementia

Interventions: Brain Safe App, Attention Control App

Countries: United States

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 or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* ≥ 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 Criteria:

* 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

Locations (2)

Indianapolis, Indiana, United States
Indianapolis, Indiana, United States