Cognitive Screening Made Easy for PCPs - R33 Phase

February 2, 2026 updated by: Robin C. Hilsabeck, University of Texas at Austin
This project will facilitate early detection of cognitive decline in older adults through development and implementation of an automated risk assessment and cognitive screening tool for use in primary care. By providing an automated tool developed specifically to address the needs of PCPs, it will be easier to screen for cognitive impairment, increasing the number of older adults who are screened and thus identified and treated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In the United States and around the world, people are living longer lives. As the population ages, so does the number of older adults who may experience declines in memory, attention, reasoning, or other thinking skills. Some of these changes in cognition can be treated and reversed if caught early. Others can be slowed down and hopefully one day prevented. Unfortunately, people with cognitive decline or very mild dementia often are not recognized until late in the disease course when treatments are less effective. As the first health care professional most people reach out to about medical concerns, primary care providers play a critical role in detecting cognitive decline early. While many primary care providers conduct cognitive screening at Medicare Annual Wellness Visits and when patients voice concerns, 9 out of 10 would like more information about who to screen, which assessment tool to use, and what to say if screening is positive. Deciding who to screen with a brief cognitive assessment tool is a key part of the process because not everyone needs to be screened, and primary care providers already face time pressures to address the obvious and immediate concerns of their patients. The long-term goal of this project is to develop a risk assessment and cognitive screening tool that requires minimal time and effort from primary care providers or their staff and is sensitive to cognitive decline in older adults from diverse educational and racial/ethnic backgrounds. The tool will be integrated into electronic health record systems to make it easy for primary care providers and patients to see results. The specific aims for the R33 phase of this project are to further test the effectiveness of the newly developed risk assessment and cognitive screening application in 500 older adults receiving care in two primary care clinics, to find out from primary care providers using the tool how much they liked it and if it was useful and easy to use, and to integrate findings into multiple electronic health record systems. Findings from this project will fill a gap in the existing toolkit of primary care providers and will make screening for cognitive decline quick, easy, and effective.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Family Wellness Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

A total of 500 older adults will be recruited from two primary care clinics affiliated with The University of Texas (UT) at Austin: the Family Wellness Center (FWC) and UT Health Austin's Primary Care Clinic (PCC).

Description

Inclusion Criteria:

  • Aged 60 years and older;
  • Ethnic/racial background consistent with NIH policy
  • Male or female
  • Fluent in English.

Exclusion Criteria:

  • Confounding conditions that could impact ability to participate in the study (e.g., cognitive impairment sufficient to impact ability to follow instructions on the iPad, motor impairment that would prohibit independent use of RACS, poor visual acuity)
  • Prior diagnosis of dementia
  • Non-English speaking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Risk assessment and cognitive screening app that includes questions answered by the participant and completion of a working memory task and two speech tasks
Behavioral: RACS app
risk assessment questions, symbol matching task, voice tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Performance Score
Time Frame: baseline, 6 month, and 12 month visits
Combination of symbol matching and voice tasks, which generates a cognitive performance score ranging from 0 to 1 (high scores mean higher likelihood of cognitive impairment)
baseline, 6 month, and 12 month visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: baseline, 6 month, and 12 month visits
Questions about usability completed by clinic staff and PCPs. The scale is a modified version of the Usefulness, Satisfaction, and Ease of Use (USE) questionnaire. Scores range from 8 to 56, with higher scores indicative of greater usability.
baseline, 6 month, and 12 month visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Robin C Hilsabeck, PhD, University of Texas Health Sciences Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG069780-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final dataset will include demographic and clinical data, scores on neuropsychological tests, speech samples, and machine learning algorithms.

IPD Sharing Time Frame

Release of the final data and RACS app will be made available by the online publication date

IPD Sharing Access Criteria

We will publish all of our code and scripts for statistical analysis and machine learning development on a publically available GitHub repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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