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DementiaNCT05356702

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

A study testing Brain Health Assessment in people with Dementia and Alzheimer Disease, run by Kaiser Permanente at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Alzheimer Disease
What is being tested?
Brain Health Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,417 participants
Where
5 sitesUnited States
Study dates
29 Jun 2022to 3 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • Currently receiving hospice care

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Kaiser Permanente Burien Medical Center

    Burien, Washington, 98166

  • Kaiser Permanente Kent Medical Center

    Kent, Washington, 98030

  • Kaiser Permanente Renton Medical Center

    Renton, Washington, 98056

  • Kaiser Permanente, Capitol Hill

    Seattle, Washington, 98112

  • Kaiser Permanente Northgate Medical Center

    Seattle, Washington, 98115

Other trials in United States

About this study

Official title: Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the eRADAR Algorithm in a Pragmatic, Patient-centered Trial.

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

Read the 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. We 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. We will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.

Being tested
Brain Health Assessment
Medical subject headings
Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain Health AssessmentOther

    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.

Study groups in NCT05356702
Study groupRoleWhat they receive
Brain Health InterventionExperimentalParticipants 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.
Receives: Other: Brain Health Assessment
Usual careNo interventionIndividuals 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New Dementia Diagnoses

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

    Measured: 12 months after index date

Secondary outcomes (12)

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

    Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data

    Measured: 12 months after index date

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

    Dementia diagnosis rate in 18 months defined from EHR data

    Measured: 18 months after index date

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

    Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR.

    Measured: 6 months

  4. Number of Patients Who Received a New Dementia Medication

    Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record

    Measured: 12 months after index date

  5. Number of Patients With Urgent Care/Emergency Department Visits

    Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation.

    Measured: 1 year after index date

  6. Average Number of Hospitalizations

    Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation.

    Measured: 1 year after index date

  7. Average Number of "no Shows" for Scheduled Clinic Visits

    Average number of scheduled clinic visits missed per participant

    Measured: 1 year after index date

  8. Average Number of Visits in Primary Care - 6 Months

    Average number of visits in primary care in the 6 months after study initiation

    Measured: 6 months

  9. Average Number of Visits in Primary Care - 12 Months

    Average number of visits in primary care in the 12 months after study initiation

    Measured: 12 months

  10. Number of Patients Who Received a B12 Lab Test

    Number of participants with at least 1 B12 lab test in the 12 months after study initiation.

    Measured: 12 months

  11. Number of Patients Who Received Neuroimaging

    Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation.

    Measured: 12 months

  12. Number of Patients Who Received Neurology Referrals

    At least one referral to Neurology or Speech, Language, \& Learning in 12 months following study initiation.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start29 Jun 2022
  3. Primary completion3 Mar 2025
  4. Study completion3 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,417 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05356702
Sponsor's protocol ID
1R01AG067427
Status last verified
Jun 2026
First submitted
27 Apr 2022
Last updated
6 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This Individual Participant Data (IPD) plan applies to all quantitative study data, such as data collected specifically for the study and those derived from electronic health records (EHR), as well as the data collected via planned study surveys, which include only short qualitative free-text fields. We do not plan to share transcripts from in-depth qualitative interviews or recorded study assessment visits. Data will be maintained on secure servers behind the firewalls at the two study sites: Kaiser Permanente Washington (KPWA) and the University of California, San Francisco (UCSF). De-identified or limited datasets containing individual-level data on which publications are based will be made available to qualified researchers for specified analyses. We will make the data available to users only under a data-use agreement (DUA).

Publications

  • 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.

    PubMed 28849435

  • 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.

    PubMed 31612463

  • 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.

    PubMed 34702167

Questions about this trial

What is this clinical trial studying?

A study testing Brain Health Assessment in people with Dementia and Alzheimer Disease, run by Kaiser Permanente at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Dementia Diagnoses (time frame: 12 months after index date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05356702, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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