Cognitive Screening Made Easy for PCPs - Administrative Supplement

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06928298
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Texas at Austin
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robin C Hilsabeck, PhD
Principal Investigator Affiliation University of Texas Health Sciences Center at San Antonio
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cognitive Impairment, Cognitive Decline, Dementia, Mild
Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Behavioral: - RACS app

risk assessment questions, symbol matching task, voice tasks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Family Wellness Clinic, Austin 4671654, Texas 4736286

Status

Address

Family Wellness Clinic

Austin 4671654, Texas 4736286, 78712

Site Contact

Heather Cuevas Cuevas, PhD

[email protected]

210-835-8748

Austin 4671654, Texas 4736286

Status

Address

University of Texas Health Austin Primary Care Clinic

Austin 4671654, Texas 4736286, 78712

Site Contact

Scott Selinger Selinger, MD

[email protected]

210-835-8748

San Antonio 4726206, Texas 4736286

Status

Address

UT Health San Antonio's Geriatrics and Supportive Care Clinic

San Antonio 4726206, Texas 4736286, 78229

Site Contact

Angelica Davila, MD

[email protected]

2104509890

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