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5-Cog 2.0: A Pragmatic Clinical Trial

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators: 3 to 4
    • Publications: details revised at 1 of 1 entry
    v10
  2. Minor Eligibility criteria expanded, about 14 words
    • Collaborators: 2 to 3
    v9
  3. Minor Site contacts updated at 1 of 2 sitesv8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Minor Start date changed from estimate of Aug 2023 to Aug 18, 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Aug 2027 to Nov 2027
    • Start date: Jul 2023 to Aug 2023
    • Site details revised at 2 of 2 sites
    v5
  2. Notable Start date: Apr 15, 2023 to Jul 2023
    • Primary completion date: May 30, 2027 to Aug 2027
    • Study completion date: Aug 30, 2027 to Nov 2027
    v4
  3. Minor Collaborators: 1 to 2v3
  4. Minor Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 1 word
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05515224
Lead Sponsor Albert Einstein College of Medicine
Collaborators: Indiana University, National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Stony Brook University
Conditions
(from sponsor)
Dementia, Cognitive Impairment
Related terms Cognitive Dysfunction, Dementia
Enrollment 6,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov