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Clinical Trials/NCT03816644
NCT03816644
Completed
Not Applicable

5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia

Albert Einstein College of Medicine1 site in 1 country1,201 target enrollmentMay 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Albert Einstein College of Medicine
Enrollment
1201
Locations
1
Primary Endpoint
New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.

Detailed Description

Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings, and is a more prevalent problem among older African-Americans and Hispanics than among older whites. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. To overcome the technical, cultural and logistic barriers of current cognitive screens and dementia care in primary care settings the investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to identify persons at high risk of developing dementia in multi-ethnic primary care populations. The 5-Cog includes the Picture based Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and a brief non-memory picture based test (Symbol Match). The cognitive assessment will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. It is coupled with a decision tree to guide clinicians through the follow up based on results of the 5-Cog. The primary objective is to test the ability of the 5-Cog and decision tree paradigm to improve dementia care in primary care patients with cognitive concerns. The investigators propose a single-blind, randomized clinical trial (RCT) in 1,200 older primary care patients with cognitive concerns who will be randomized to receive the 5-Cog (intervention group) or a 5-minute health literacy and grip assessment (active control group). Non-physicians will administer the intervention and control assessments in primary care sites and will provide results for both arms to the treating physician with a decision tree follow up guide based on the results of the assessments.

Registry
clinicaltrials.gov
Start Date
May 28, 2019
End Date
March 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 65 and older.
  • Presence of cognitive or memory concerns expressed by patient, caregiver, health care provider or other source who knows the patient.
  • Registered as patient at Montefiore Medical Center and have a primary care doctor appointment that day.
  • Able to hear and see well enough to complete intervention or control assessments.
  • English or Spanish speaking.

Exclusion Criteria

  • Prior diagnosis of dementia or MCI as ascertained by ICD-10 codes or the documentation of prescription for anti-dementia medications in EMR. Patients with a diagnosis containing any of the following terms will be excluded:
  • "Mild Cognitive Impairment"
  • "Alzheimer's Disease"
  • "Creutzfeldt-Jakob Disease"
  • "Major Neurocognitive Disorder"
  • "Minor Neurocognitive Disorder"
  • Patients with any of the following medications documented in their EMR will be excluded (generic = brand):
  • Donepezil = Aricept
  • Memantine = Namenda
  • Rivastigmine = Exelon

Outcomes

Primary Outcomes

New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.

Time Frame: 90 days after the participant is randomized

Dementia care is defined as the occurrence of any of the following endpoints following the screening visit. The endpoint is the number of participants who received 1 or more of the following orders: 1. Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR. 2. Tests ordered for reversible causes of cognitive impairment as recommended by the published guidelines of professional societies (i.e. thyroid function tests, B-12 level, Syphilis Panel, human immunodeficiency virus (HIV) test, computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans) documented in the EMR. 3. Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR. 4. Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.

Secondary Outcomes

  • New Occurrence of in Health Care Utilization(6 months after the participant is randomized)

Study Sites (1)

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