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

Indiana University706 enrolled

Overview

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.

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 secondarily improve cognitive function and health-related quality of life. 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. The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that 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. Our primary, powered outcome is the total standard daily dose (TSDD) measure of anticholinergic exposure at 12 months, which is calculated over the preceding 6 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months. The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months. Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

706

Conditions

Alzheimer Disease Dementia

Interventions

Brain Safe AppOTHER

The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.

Attention Control AppOTHER

The attention control app, called Med Safe, includes only the medication list feature.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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)

Indiana University

Indianapolis, Indiana, United States

IU Health

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Total standardized daily dose (TSDD) - from medical records

Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from medical record medication data over the prior 6 months

Time frame: 12 months

Total standardized daily dose (TSDD) - self-report medication inventory

Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from self-reported medication inventory data in the Brain Safe or attention control app

Time frame: 12 months

Secondary Outcomes

Choice reaction time (CRT)

Computer-based assessment of choice reaction time (CRT), used with simple reaction time (SRT) to assess executive function

Time frame: 12 months

Simple Reaction Time (SRT)

Computer-based test, used with Choice Reaction Time (CRT) test to compute a score, to assess executive function

Time frame: 12 months

Digit-Symbol Substitution Test (DSST)

Paper-based digit-symbol substitution test, from WAIS-IV ( Wechsler Adult Intelligence Scale-IV) Coding, used to assess processing speed

Time frame: 12 months

Hopkins Verbal Learning Test (HVLT)

Paper-based list learning and recall test, used to assess memory.

Time frame: 12 months

Trail Making Test (TMT) Parts A and B

Paper-based test, used to assess executive function

Time frame: 12 months

Data from ClinicalTrials.gov

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