5-Cog 2.0: A Pragmatic Clinical Trial

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT05515224
Status
Recruiting
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Conditions

  • Cognitive Impairment
  • Dementia

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool) — OTHER
    A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. If cognitive concerns are endorsed the 5-Cog battery will be conducted. The 5-Cog battery includes the Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation.
  • Enhanced usual care — OTHER
    A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. The results will be provided to primary care physicians.

Study Details

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 Dates

Start date
Aug 18, 2023
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
6,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)
    A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. If cognitive concerns are endorsed the 5-Cog battery will be conducted. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. Depending on whether the 5-Cog results are normal or abnormal on any one of the 3 tests, appropriate clinical decision support tools are provided to the primary care physicians in electronic medical record. The primary care physicians are not instructed to follow 5-Cog suggestions verbatim but use their clinical judgment.
  • Active Comparator: Enhanced usual care
    Educational sessions for primary care physicians and clinic staff regarding cognitive detection and medical billing will be conducted. A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. The results will be provided to primary care physicians.

Primary Outcome Measure

New cognitive impairment diagnoses in the 90-day period following presentation of cognitive concern to the primary care physician (PCP). [ Time Frame: Up to 90 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniversityBloomingtonIndiana47405
Malaz Boustani, MD, MPH
Malaz Boustani, MD, MPH (PRINCIPAL_INVESTIGATOR)
Albert Einstein College of MedicineThe BronxNew York10461
Erica Weiss, PhD
[email protected]
Erica Weiss, PhD (PRINCIPAL_INVESTIGATOR)

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