Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06090578

Conditions

Mild Cognitive Impairment

Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TabCAT Brain Health Assessment Clinical Pathway

Study Details

Brief summary:

Efficient and user-friendly paradigms to detect cognitive impairment, including dementia are needed in primary care. The TabCAT Brain Health Assessment accurately detects cognitive impairment via an appealing tablet interface with automated scoring and EMR integration. This study will evaluate the effectiveness of the paradigm on detection rates and other brain health outcomes via a pragmatic cluster randomized trial in 26 Kaiser Southern California primary care clinics.

Conditions

Mild Cognitive Impairment

Dementia

Study ID

NCT06090578

Start date

Jul 27, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient with at least one encounter at an intervention clinic during the intervention period
  • Age 18+ (limited to 65+ for primary analyses)

Exclusion Criteria:

  • Patients under the age of 18.

Study Design

Enrollment

180000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: TabCAT-Brain Health Assessment Clinical Pathway

Primary care providers concerned that their patients are exhibiting signs of cognitive decline based on patient, informant (family), or provider concerns will refer them for a TabCAT-BHA assessment and follow-up care.

no intervention: Usual Care Clinical Pathway

Patients in the control practices will continue with usual care workflows.

Interventions

TabCAT Brain Health Assessment Clinical Pathway

Primary care providers concerned that their patients are exhibiting signs of cognitive decline will refer them to clinical associates who will then perform the TabCAT-BHA tablet-based test. The TabCAT-BHA paradigm comprises 7-10 minutes of tablet-based testing and an optional 3-minute self-administered informant survey captures behavioral symptoms and change from baseline. The results are available to the PCP in the EMR along with turnkey guidance to evaluate for reversible causes, identify and involve a care partner, make and disclose diagnosis, provide community and educational resources, and make medical referrals as appropriate. Nursing support is available to support the PCP in making the diagnosis and to consult to the family via telephone post-diagnosis to address immediate care needs.

Primary outcome measure

  • The rate of patients with at least one cognitive impairment diagnosis documented in the medical record by any primary care provider during the 12-month steady state period at the clinic. [ Time Frame: During the 12-month steady state period ]

Central Contacts and Locations

Central contacts

Collette Goode, BS

415-514-0881collette.goode@ucsf.edu

Katherine Possin, PhD

415-476-1889katherine.possin@ucsf.edu

Locations

Kaiser Permanente Southern California Department of Research & Evaluation

Recruiting

Pasadena, California, United States, 91101

Contacts

Huong Q Nguyen, PhD

626-773-0873huong.q2.nguyen@kp.org

Mayra Macias

626-344-6667mayra.macias@kp.org

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • Primary care
  • Cognitive assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-10-31.