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

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease; Dementia
• Interventions: Other: Brain Safe App; Other: Attention Control App

• Registration Number: NCT04121858
• Lead Sponsor: Indiana University

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 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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Start: 2019-10-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 706

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain Safe App	Brain Safe App	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.
Attention Control App	Attention Control App	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.

Primary Outcome Measures

Name	Time	Method
Total standardized daily dose (TSDD) - from medical records	12 months	Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from medical record medication data over the prior 6 months
Total standardized daily dose (TSDD) - self-report medication inventory	12 months	Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from self-reported medication inventory data in the Brain Safe or attention control app

Secondary Outcome Measures

Name	Time	Method
Simple Reaction Time (SRT)	12 months	Computer-based test, used with Choice Reaction Time (CRT) test to compute a score, to assess executive function
Hopkins Verbal Learning Test (HVLT)	12 months	Paper-based list learning and recall test, used to assess memory.
Choice reaction time (CRT)	12 months	Computer-based assessment of choice reaction time (CRT), used with simple reaction time (SRT) to assess executive function
Trail Making Test (TMT) Parts A and B	12 months	Paper-based test, used to assess executive function
Health Utilities Index (HUI) Mark 3	12 months	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
Digit-Symbol Substitution Test (DSST)	12 months	Paper-based digit-symbol substitution test, from WAIS-IV ( Wechsler Adult Intelligence Scale-IV) Coding, used to assess processing speed

Trial Locations

Locations (2)

Richard John Holden; 🇺🇸 Indianapolis, Indiana, United States

IU Health; 🇺🇸 Indianapolis, Indiana, United States