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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Other: Brain Safe App
* Other: Attention Control App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Safe App<br>1)Brain Safe App provides conversation starters for older adult patients on target anticholinergics. The conversation starters assist the patient to have discussions with their physicians regarding reduction in exposure to prescription anticholinergics. 2) Provides anticholinergic risk assessment. | Other: Brain Safe App<br>* The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.<br>|
| Sham Comparator: Attention Control App<br>1) Attention Control App provides a medication list for older patients to use but lacks the conversation starters for patient to use with there physicians aimed at reduction in exposure to prescription anticholinergics.2) No anticholinergic risk assessment. | Other: Attention Control App<br>* The attention control app, called Med Safe, includes only the medication list feature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice reaction time (CRT) | Computer-based assessment of choice reaction time (CRT), used with simple reaction time (SRT) to assess executive function | 12 months | 
| Simple Reaction Time (SRT) | Computer-based test, used with Choice Reaction Time (CRT) test to compute a score, to assess executive function | 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 | 12 months | 
| Hopkins Verbal Learning Test (HVLT) | Paper-based list learning and recall test, used to assess memory. | 12 months | 
| Trail Making Test (TMT) Parts A and B | Paper-based test, used to assess executive function | 12 months | 
| Health Utilities Index (HUI) Mark 3 | Self-reported measure of health-related quality of life, producing a single score on a standardized utility values range from -0.36 for the HUI-3, respectively, to 1.00 with higher scores indicating better outcome | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticholinergic, cognitive function, brain, aging