Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID05515224

5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial

Led by Albert Einstein College of Medicine ยท Updated on 2026-04-17

6600

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Albert Einstein College of Medicine

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Cognitive impairment related to dementia is often missed in primary care, especially among older adults from minority and socio-economically disadvantaged populations. Researchers are evaluating the 5-Cog brief cognitive assessment, a quick, simple, and standardized tool that takes less than 5 minutes and addresses cultural and logistical barriers. This pragmatic cluster-randomized trial aims to test whether the 5-Cog paradigm improves detection of new cases of cognitive impairment and dementia care in older adults with cognitive concerns. The study involves 22 primary care clinics in Bronx and Indiana, enrolling about 6,600 patients aged 65 and older who report cognitive concerns. Participants receive either the 5-Cog battery combined with a clinical decision-making tool or enhanced usual care, which includes cognitive concern screening. The 5-Cog battery includes tests like Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. Primary care physicians receive results and decision support but use their clinical judgment in care decisions. Participants undergo cognitive concern screening before their appointments. Researchers will review new cognitive impairment diagnoses and improvements in dementia care within 90 days after the primary care visit using electronic medical records. Additional evaluations include tests for reversible causes, medication changes, specialist referrals, and social support. The study also examines the 5-Cog paradigm's implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.

CONDITIONS

Brief Title

5-Cog 2.0: A Pragmatic Clinical Trial

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 65 years and older
  • Presence of cognitive concerns
  • English or Spanish speaking
  • Able to see and hear well enough to complete assessments
Not Eligible

You will not qualify if you...

  • Prior diagnosis of dementia documented or reported
  • Permanent nursing facility residents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) prior to primary care appointment

Treatment

Duration - Up to 90 days following presentation of cognitive concern

Participants undergo cognitive concern screening and, if concerns are endorsed, complete the 5-Cog cognitive assessment or receive enhanced usual care. Primary care physicians receive results and may use clinical decision support tools to guide care.

Assessment occurs prior to primary care appointment; follow-up care as part of routine clinical visits

Follow-up

Duration - Up to 90 days following cognitive concern presentation

Participants are monitored for new cognitive impairment diagnoses and improvements in dementia care based on care actions taken by primary care physicians.

No additional visits; outcomes assessed via electronic medical records

Trial Site Locations

Total: 2 locations

1

Indiana University

Bloomington, Indiana, United States, 47405

Actively Recruiting

2

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

Actively Recruiting

Loading map...

Research Team

E

Emmeline Ayers, MPH

E

Erica Weiss, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

A Digital Life Story to Support Person-centred Care for Olde...

Cognitive Impairment

Actively Recruiting

1 location

A Mechanistic Study to Investigate tDCS and Working Memory i...

Cognitive Impairment

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial.

Rachel Beth Rosansky Chalmer, Emmeline Ayers, Erica F Weiss...

https://pubmed.ncbi.nlm.nih.gov/40179383