NCT04121858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
706

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5.4 years

First QC Date

October 2, 2019

Last Update Submit

March 11, 2025

Conditions

Alzheimer DiseaseDementia

Keywords

anticholinergiccognitive functionbrainaging

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Choice reaction time (CRT)

    12 months

  • Simple Reaction Time (SRT)

    12 months

  • Digit-Symbol Substitution Test (DSST)

    12 months

  • Hopkins Verbal Learning Test (HVLT)

    12 months

  • Trail Making Test (TMT) Parts A and B

    12 months

  • +1 more secondary outcomes

Other Outcomes (5)

  • Medication perceptions

    12 months

  • Self-reported deprescribing behavior

    12 months

  • System Usability Scale

    12 months

  • +2 more other outcomes

Study Arms (2)

Brain Safe App

EXPERIMENTAL

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

Attention Control App

SHAM COMPARATOR

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

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.

Brain Safe App
Attention Control AppOTHER

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

Attention Control App

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

IU Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • 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.

    PMID: 33773639DERIVED

  • 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.

    PMID: 33606655DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Richard J Holden, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The primary investigator and outcome assessor will be masked to the App assignment (Brain Safe vs Attention Control Medication list App)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Indiana University School of Medicine Chief Healthcare Engineer, Center for Health Innovation and Implementation Science

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 10, 2019

Study Start

October 16, 2019

Primary Completion

February 27, 2025

Study Completion

February 27, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers

Locations

US(2)