Actively Recruiting
5-Cog 2.0: A Pragmatic Clinical Trial
Led by Albert Einstein College of Medicine · Updated on 2026-04-17
6600
Participants Needed
2
Research Sites
219 weeks
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 frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. The investigators developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes \<5 minutes, does not require informants, and accounts for major technical, cultural, and logistical barriers of current assessments. The investigators propose a hybrid Type 1 effectiveness-implementation design in real-world settings to adapt and test the effectiveness of the 5-Cog paradigm to increase detection of cognitive impairment care in older adults presenting with cognitive concerns. The study aim is to evaluate, using a pragmatic cluster-randomized trial design, the effectiveness of the 5-Cog paradigm to increase 'incident cognitive impairment' detection (new MCI and dementia diagnoses) relative to enhanced usual care in 6,600 older patients presenting with cognitive concerns in 22 primary care clinics in Bronx and Indiana. As diagnosis without action will not improve patient care, 'improved dementia care' will be examined as a secondary outcome. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.
CONDITIONS
Official Title
5-Cog 2.0: A Pragmatic Clinical Trial
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- Prior diagnosis of dementia documented in medical records or reported by physicians
- Permanent residents of nursing facilities
AI-Screening
AI-Powered Screening
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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
Research Team
E
Emmeline Ayers, MPH
CONTACT
E
Erica Weiss, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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