Clinical trial NCT04121858: Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
Official title: Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: anticholinergic
cognitive function
brain
aging
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-10-10
Enrollment: 706
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Total standardized daily dose (TSDD) - from medical records
timeFrame: 12 months
measure: Total standardized daily dose (TSDD) - self-report medication inventory
timeFrame: 12 months
Secondary outcomes:
measure: Choice reaction time (CRT)
timeFrame: 12 months
measure: Simple Reaction Time (SRT)
timeFrame: 12 months
measure: Digit-Symbol Substitution Test (DSST)
timeFrame: 12 months
measure: Hopkins Verbal Learning Test (HVLT)
timeFrame: 12 months
measure: Trail Making Test (TMT) Parts A and B
timeFrame: 12 months
measure: Health Utilities Index (HUI) Mark 3
timeFrame: 12 months
Other outcomes:
measure: Medication perceptions
timeFrame: 12 months
measure: Self-reported deprescribing behavior
timeFrame: 12 months
measure: System Usability Scale
timeFrame: 12 months
measure: Satisfaction with technology: 3-item standardized survey
timeFrame: 12 months
measure: Technology use
timeFrame: 12 months
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Richard J Holden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abebe E, Campbell NL, Clark DO, Tu W, Hill JR, Harrington AB, O'Neal G, Trowbridge KS, Vallejo C, Yang Z, Bo N, Knight A, Alamer KA, Carter A, Valenzuela R, Adeoye P, Boustani MA, Holden RJ. Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial. Res Social Adm Pharm. 2021 May;17(5):986-992. doi: 10.1016/j.sapharm.2020.10.010. Epub 2020 Oct 22.
citation: Hill JR, Harrington AB, Adeoye P, Campbell NL, Holden RJ. Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26702. doi: 10.2196/26702.