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

NCT05356702 | Completed Results DMC

• 1 other identifier: 1R01AG067427
• Study Type: interventional
• Target: 3,417
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• New Dementia Diagnoses

  Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

  12 months after index date

Secondary Outcomes (12)

• Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia

  12 months after index date

• Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up

  18 months after index date

• Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up

  6 months

• Number of Patients Who Received a New Dementia Medication

  12 months after index date

• Number of Patients With Urgent Care/Emergency Department Visits

  1 year after index date

Study Arms (2)

Brain Health Intervention

EXPERIMENTAL

Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician (PCP), who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.

Other: Brain Health Assessment

Usual care

NO INTERVENTION

Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).

Interventions

Brain Health Assessment 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. They 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.

Brain Health Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Currently receiving hospice care

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• Kaiser Permanente: lead

Study Sites (5)

Kaiser Permanente Burien Medical Center

Burien, Washington, 98166, United States

Location

Kaiser Permanente Kent Medical Center

Kent, Washington, 98030, United States

Location

Kaiser Permanente Renton Medical Center

Renton, Washington, 98056, United States

Location

Kaiser Permanente, Capitol Hill

Seattle, Washington, 98112, United States

Location

Kaiser Permanente Northgate Medical Center

Seattle, Washington, 98115, United States

Location

Related Publications (3)

• 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.

  PMID: 28849435 BACKGROUND

• 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.

  PMID: 31612463 BACKGROUND

• Palazzo L, Hsu C, Barnes DE, Gray MF, Greenwood-Hickman MA, Larson EB, Dublin S. Patient and caregiver perspectives on a tool to increase recognition of undiagnosed dementia: a qualitative study. BMC Geriatr. 2021 Oct 26;21(1):604. doi: 10.1186/s12877-021-02523-0.

  PMID: 34702167 BACKGROUND

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Sascha Dublin, MD, PhD
• Organization: Kaiser Permanente Washington Health Research Institute

Sascha.Dublin@kp.org

206-287-2870

Study Officials

• Sascha Dublin, MD, PhD

  KP Washington Health Research Institute

  PRINCIPAL INVESTIGATOR

• Deborah E. Barnes, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: June 29, 2022
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2026
• Last Updated: July 6, 2026
• Results First Posted: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
• Access Criteria: Individuals interested in using KPWA data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of Institutional Review Board (IRB) approval. Data may then be accessed by qualified researchers via KPWA's Secure File Transfer (SFT) site. User registration will be required in order to access or download data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.

Locations

US (5)