Mild Cognitive ImpairmentNCT06090578
TabCAT Brain Health Assessment in Primary Care
A study testing TabCAT Brain Health Assessment Clinical Pathway in people with Mild Cognitive Impairment and Dementia, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- What is being tested?
- TabCAT Brain Health Assessment Clinical Pathway
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with at least one encounter at an intervention clinic during the intervention period
- Age 18+ (limited to 65+ for primary analyses)
Who cannot join
- Patients under the age of 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Southern California Department of Research & Evaluation
Pasadena, California, 91101
Huong Q Nguyen, PhD, 626-773-0873, huong.q2.nguyen@kp.org
Mayra Macias, 626-344-6667, mayra.macias@kp.org
About this study
Official title: A Pragmatic Trial of the TabCAT Brain Health Assessment for the Detection of Cognitive Impairment in Primary Care
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.
Read the detailed description
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
- Mild Cognitive Impairment, Dementia
- Being tested
- TabCAT Brain Health Assessment Clinical Pathway
- Keywords
- Primary care, Cognitive assessment
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TabCAT Brain Health Assessment Clinical PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TabCAT-Brain Health Assessment Clinical Pathway | Experimental | 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. Receives: Other: TabCAT Brain Health Assessment Clinical Pathway |
| Usual Care Clinical Pathway | No intervention | Patients in the control practices will continue with usual care workflows. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Rate is out of all patients with an encounter during the steady state period at the clinic. The primary analyses for all outcomes are limited to ages 65+.
Measured: During the 12-month steady state period
Secondary outcomes (2)
The rate of patients who have a documented standardized cognitive assessment performed in the primary care clinic within 4 months of an incident cognitive impairment diagnosis.
Rate is out of all patients with an encounter at the clinic during the 12-month steady state period and an incident cognitive impairment diagnosis. The window for incident cognitive impairment diagnoses will be the steady state period + 4 months after. The standardized cognitive assessment must occur during the steady state period and +/- 4 months of the incident diagnosis. All standardized cognitive assessments will be counted. Incident diagnoses are the first time that any of these diagnoses are documented in the medical record by any outpatient provider, using a 2 year look back window. In addition, incident diagnoses of mild cognitive impairment and dementia will be counted even if an "other cognitive impairment diagnosis" was previously made.
Measured: During the 12-month steady state period
The rate of patients who have a referral to Geriatrics, Neurology or Psychiatry.
Rate is out of all patients with an incident diagnosis, as defined in Outcome 2. The referral must occur within the 12-month steady state period + 4 months after, and within +/- 4 months of the incident diagnosis.
Measured: During the 12-month steady state period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start27 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Possin, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090578
- Sponsor's protocol ID
- U01NS128913
- Other IDs
- U01NS128913
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2023
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of Kaiser Permanente Southern California.
Publications
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.
PubMed 35124639Sideman 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.
PubMed 39107706
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of the TabCAT Brain Health Assessment for the Detection of Cognitive Impairment in Primary Care
- ClinicalTrials.gov ID
- NCT06090578
- Acronym / sponsor ID
- U01NS128913
- Conditions
- Mild Cognitive Impairment, Dementia
- Keywords
- Primary care, Cognitive assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TabCAT-Brain Health Assessment Clinical Pathway | Experimental | Other: TabCAT Brain Health Assessment Clinical PathwayPrimary 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. |
| Usual Care Clinical Pathway | No intervention | –Patients in the control practices will continue with usual care workflows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with at least one encounter at an intervention clinic during the intervention period
- Age 18+ (limited to 65+ for primary analyses)
Key exclusion criteria (1 listed)
- Patients under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TabCAT Brain Health Assessment Clinical PathwayPrimary 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. | Other | TabCAT-Brain Health Assessment Clinical Pathway |
Primary outcome
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
Rate is out of all patients with an encounter during the steady state period at the clinic. The primary analyses for all outcomes are limited to ages 65+.
2 secondary outcomes
The rate of patients who have a documented standardized cognitive assessment performed in the primary care clinic within 4 months of an incident cognitive impairment diagnosis.
Time frame: During the 12-month steady state period
The rate of patients who have a referral to Geriatrics, Neurology or Psychiatry.
Time frame: During the 12-month steady state period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Results publication: PubMed 35124639Bernstein 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.
- Derived from this study: PubMed 39107706Sideman 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of Kaiser Permanente Southern California.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Possin, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TabCAT Brain Health Assessment Clinical Pathway in people with Mild Cognitive Impairment and Dementia, run by University of California, San Francisco at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Collette Goode, BS (415-514-0881, collette.goode@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). 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 NCT06090578, which also lists 2 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 31 Oct 2025.