Cognitive Screening Made Easy for PCPs - R33 Phase

Cognitive Impairment Clinical Trial

Official title:

Cognitive Screening Made Easy for PCPs - R33 Phase

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162026
• Other study ID #: AG069780-03
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: University of Texas at Austin
• Contact: Robin C Hilsabeck, PhD
• Phone: 210-835-8748
• Email: robin.hilsabeck[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Mild

Intervention

Behavioral:
• RACS app
risk assessment questions, symbol matching task, voice tasks

Locations

Country	Name	City	State
United States	Family Wellness Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Performance Score	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	Usability	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