TabCAT Brain Health Assessment in Primary Care

NCT ID: NCT06090578

Last Updated: 2025-10-31

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Twenty-six Kaiser Permanente Southern California (KPSC) primary care clinics will be randomized in two waves to receive either the TabCAT-BHA paradigm or usual care. Clinics have been matched in pairs by number of providers, median panel size, the racial/ethnic makeup of the patient panel, baseline rates of cognitive impairment diagnosis, rates of telehealth encounters, and percentage of members who are 65+ in the practice. The trial will be conducted over two 18-month waves, with six intervention practices in the first wave and seven intervention practices starting in the second wave. All patients seen at least once across these 26 practices will be included in the trial and the primary analyses will use data extracted from the EMR. Patients in the intervention practices will receive care in accordance with the TabCAT-BHA paradigm whereas patients in the control practices will continue with usual care workflows. The intervention will include a 6-month startup period during which the research team will partner with the physician leads to adapt the paradigm workflows to each practice and onboard the PCPs, and then a 12-month steady state period when effectiveness on the primary and secondary outcomes will be measured. During the TabCAT-BHA paradigm intervention, pragmatically, primary care providers concerned that their patients are exhibiting signs of cognitive decline will refer them to clinical research associates located in the primary care clinics who will then perform the TabCAT-BHA tablet-based test either on the spot or as a scheduled procedure visit. The tablet-based test provides an automated scoring report that includes guidance for providers to identify reversible causes of cognitive impairment, involving a care partner, diagnostic disclosure, community and educational resources, and specialty referral including the option to refer the patient for a "Brain Health Consultation" telephone call with a study nurse or social worker.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a pragmatic cluster randomized trial. 26 primary care clinics will be randomized in two 18-month waves to receive either the TabCAT-BHA paradigm or usual care. The first wave will include six intervention practices and the second wave will include seven intervention practices.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

TabCAT Brain Health Assessment Clinical Pathway

Intervention Type OTHER

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.

Usual Care Clinical Pathway

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaiser Permanente

OTHER

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katherine Possin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaiser Permanente Southern California Department of Research & Evaluation

Pasadena, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Collette Goode, BS

Role: CONTACT

415-514-0881

Katherine Possin, PhD

Role: CONTACT

415-476-1889

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Huong Q Nguyen, PhD

Role: primary

626-773-0873

Mayra Macias

Role: backup

626-344-6667

References

Explore related publications, articles, or registry entries linked to this study.

Bernstein Sideman A, Chalmer R, Ayers E, Gershon R, Verghese J, Wolf M, Ansari A, Arvanitis M, Bui N, Chen P, Chodos A, Corriveau R, Curtis L, Ehrlich AR, Tomaszewski Farias SE, Goode C, Hill-Sakurai L, Nowinski CJ, Premkumar M, Rankin KP, Ritchie CS, Tsoy E, Weiss E, Possin KL. Lessons from Detecting Cognitive Impairment Including Dementia (DetectCID) in Primary Care. J Alzheimers Dis. 2022;86(2):655-665. doi: 10.3233/JAD-215106.

Reference Type RESULT
PMID: 35124639 (View on PubMed)

Sideman AB, Nguyen HQ, Langer-Gould A, Lee EA, Borson S, Shen E, Tsoy E, Macias M, Goode C, Rankin K, Kramer J, Possin KL. Stakeholder-informed pragmatic trial protocol of the TabCAT-BHA for the detection of cognitive impairment in primary care. BMC Prim Care. 2024 Aug 6;25(1):286. doi: 10.1186/s12875-024-02544-9.

Reference Type DERIVED
PMID: 39107706 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U01NS128913

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01NS128913

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

5-Cog 2.0: A Pragmatic Clinical Trial
NCT05515224 RECRUITING NA