The Brain Health Study: A Pragmatic, Patient-Centered Trial

NCT ID: NCT05905796

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2025-10-06

Brief Summary

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The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

Detailed Description

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Detailed description: eRADAR stands for "electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule." It is a low-cost tool or algorithm that uses readily available EHR data elements to identify high-risk patients. The investigators will conduct a pragmatic randomized controlled trial to assess the impact of implementing eRADAR as part of a supported outreach process on dementia detection rates. The investigators will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.

Conditions

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Dementia Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Brain Health Intervention

Calculate eRADAR scores using EHR data to identify eligible individuals Invite eligible individuals for brain health assessment visit Enter results of brain health assessment visit into EHR Provide summary of results and recommended next steps to the Primary Care Physician and participant

Group Type EXPERIMENTAL

Brain Health Assessment

Intervention Type OTHER

Research interventionists, who will be trained and licensed health practitioners (e.g., social workers), will ask participants about changes in memory or thinking and daily function, screen for depression, and administer a standard cognitive screening test. Research interventionalists will use a standardized note template to document results in the participant's EHR. Research interventionists will notify participants and PCPs if follow-up is recommended.

Usual Care

Usual care Individuals who meet eligibility criteria will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brain Health Assessment

Research interventionists, who will be trained and licensed health practitioners (e.g., social workers), will ask participants about changes in memory or thinking and daily function, screen for depression, and administer a standard cognitive screening test. Research interventionalists will use a standardized note template to document results in the participant's EHR. Research interventionists will notify participants and PCPs if follow-up is recommended.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No prior diagnosis of dementia (defined from EHR diagnosis codes) and not receiving medications for dementia
* Active patient at participating clinic
* Adequate data to calculate eRADAR score

Exclusion Criteria

\- Currently receiving hospice care
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Sascha Dublin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KP Washington Health Research Institute

Locations

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UCSF Primary Care at China Basin

San Francisco, California, United States

Site Status

Division of General Internal Medicine

San Francisco, California, United States

Site Status

Women's Health Primary Care

San Francisco, California, United States

Site Status

Countries

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United States

References

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Dublin S, Greenwood-Hickman MA, Karliner L, Hsu C, Coley RY, Colemon L, Carrasco A, King D, Grace A, Lee SJ, Walsh JME, Barrett T, Broussard J, Singh U, Idu A, Yaffe K, Boustani M, Barnes DE. The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm. Contemp Clin Trials. 2023 Dec;135:107356. doi: 10.1016/j.cct.2023.107356. Epub 2023 Oct 17.

Reference Type BACKGROUND
PMID: 37858616 (View on PubMed)

Lee SJ, Larson EB, Dublin S, Walker R, Marcum Z, Barnes D. A Cohort Study of Healthcare Utilization in Older Adults with Undiagnosed Dementia. J Gen Intern Med. 2018 Jan;33(1):13-15. doi: 10.1007/s11606-017-4162-3. No abstract available.

Reference Type BACKGROUND
PMID: 28849435 (View on PubMed)

Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14.

Reference Type BACKGROUND
PMID: 31612463 (View on PubMed)

Coley RY, Smith JJ, Karliner L, Idu AE, Lee SJ, Fuller S, Lam R, Barnes DE, Dublin S. External Validation of the eRADAR Risk Score for Detecting Undiagnosed Dementia in Two Real-World Healthcare Systems. J Gen Intern Med. 2023 Feb;38(2):351-360. doi: 10.1007/s11606-022-07736-6. Epub 2022 Jul 29.

Reference Type BACKGROUND
PMID: 35906516 (View on PubMed)

Other Identifiers

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1R01AG069734

Identifier Type: NIH

Identifier Source: secondary_id

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1R01AG069734

Identifier Type: NIH

Identifier Source: org_study_id

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