5-Cog 2.0: A Pragmatic Clinical Trial

Recruiting now · Not applicable

Conditions studied: Dementia, Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT05515224

Run by

Albert Einstein College of Medicine

People needed

6600

Starts

2023-08-18

Expected to finish

2027-11-01

Last updated by the study team

2026-04-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 65 years and older
• Presence of cognitive concerns
• English or Spanish speaking.
• Able to see and hear well enough to complete assessments.

You may not qualify if…

• Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
• Permanent nursing facility residents.

Where it is running

• Indiana University — Bloomington, Indiana, United States (enrolling)
• Albert Einstein College of Medicine — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.