Skip to content

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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05356702
Enrollment
3417
Registered
2022-05-02
Start date
2022-06-29
Completion date
2025-04-15
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Alzheimer Disease

Brief summary

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

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.

Interventions

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.

Sponsors

University of California, San Francisco
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
New dementia diagnoses12 months after index dateRate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

Secondary

MeasureTime frameDescription
Dementia medications6 months after index datePercent of participants who receive new medications for dementia, defined from medication orders or dispensings in the electronic health record
Urgent care/emergency department visits1 year after index dateNumber of urgent care and emergency department visits
Hospitalizations1 year after index dateNumber of inpatient stays
Clinic no shows1 year after index dateNumber of scheduled visits missed
Healthcare utilization6 months after index dateNumber of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data
New dementia diagnoses (secondary definitions)6 months after index date; 18 months after index dateDementia diagnosis rate in different time periods than for primary outcome, defined from EHR data
New diagnoses of mild cognitive impairment12 months after index dateRate of new diagnoses of mild cognitive impairment following the intervention, defined from EHR data
Rate of accepting brain health visit3 months after invitation mailedProportion of people offered a brain health visit who accept and attend the visit
Positive predictive value of eRADAR algorithm12 months after index dateProportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia
Medication adherence1 year after index dateProportion of days covered

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026