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NCT Number: NCT06928298

Cognitive Screening Made Easy for PCPs - Administrative Supplement

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.

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Key information

About this study

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 administrative supplement of the R33 phase of this project are to further test the effectiveness of the newly developed risk assessment and cognitive screening application in 100 Spanish speaking older adults receiving care in 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, effective and accessible in more than one language.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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-Spanish speaking.

Treatment and study plan

RACS app

Behavioral

risk assessment questions, symbol matching task, voice tasks

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Chang, Md, PhD

CONTACT

[email protected]

Robin C Hilsabeck, PhD

CONTACT

[email protected]

210-835-8748

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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