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5-Cog Battery for Detecting Cognitive Impairment and Dementia (5-Cog)

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ClinicalTrials.gov Identifier: NCT03816644
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Joe Verghese, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
Change 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.
  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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
Change 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 a sum of an occurrence of any of the following endpoints following this screening visit.
  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.
  5. Referral to social worker documented in the EMR.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
Change in health care utilization [ Time Frame: 6 months after the participant is randomized ]
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
Change in health care utilization [ Time Frame: 90 days after the participant is randomized ]
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2019)
  • Cost-effectiveness [ Time Frame: 6 months after the participant is randomized ]
    Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.
  • Change in health care utilization [ Time Frame: 12 months after the participant is randomized ]
    Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
  • Cost-effectiveness [ Time Frame: 12 months after the participant is randomized ]
    Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.
Original Other Pre-specified Outcome Measures
 (submitted: January 24, 2019)
Cost-effectiveness [ Time Frame: 90 days after the participant is randomized ]
Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.
 
Descriptive Information
Brief Title  ICMJE 5-Cog Battery for Detecting Cognitive Impairment and Dementia
Official Title  ICMJE 5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE
  • Dementia
  • Cognitive Impairment
  • Mild Cognitive Impairment
  • Neurocognitive Disorders
Intervention  ICMJE
  • Other: 5-Cog
    The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.
  • Other: Health Literacy & Grip Assessment
    The health literacy and grip assessment will take approximately 5 minutes, and will test the patient's comprehension and pronunciation of health-related terms as well as strength in their dominant hand. The screen will sort out patients with 'low health literacy' and 'frail (low grip strength)' from those with normal health literacy and normal grip strength.
Study Arms  ICMJE
  • Experimental: 5-Cog
    The 5-Cog coupled with a decision tree is a simple, 5-minute procedure that will identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after randomization and before the patients sees the physician. The 5-Cog will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. After completing the 5-Cog, the non-physician tester will send a message through the Electronic medical record (EMR) system to provide the physician with the 5-Cog results and guide the them through the follow-up based on the results.
    Intervention: Other: 5-Cog
  • Active Comparator: Health Literacy & Grip Assessment
    The 5 minute assessment includes the Short Assessment of Health Literacy (SAHL) and a grip assessment measured using a handgrip dynamometer. After completing the SAHL and grip assessment, the non-physician tester will send a message through the EMR to provide the physician with the results from the assessments and guide the them through the follow-up based on the results.
    Intervention: Other: Health Literacy & Grip Assessment
Publications * Malik R, Weiss EF, Gottesman R, Zwerling J, Verghese J. Picture-Based Memory Impairment Screen: Effective Cognitive Screen in Ethnically Diverse Populations. J Am Geriatr Soc. 2018 Aug;66(8):1598-1602. doi: 10.1111/jgs.15422. Epub 2018 May 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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:

    1. "Dementia"
    2. "Mild Cognitive Impairment"
    3. "Alzheimer's Disease"
    4. "Creutzfeldt-Jakob Disease"
    5. "Major Neurocognitive Disorder"
    6. "Minor Neurocognitive Disorder"

    Patients with any of the following medications documented in their EMR will be excluded (generic = brand):

    1. Donepezil = Aricept
    2. Memantine = Namenda
    3. Rivastigmine = Exelon
    4. Galantamine = Razadyne
    5. Donepezil and Memantine = Namzaric
  2. Adults who are permanent residents of a nursing facility.
  3. Patients who do not speak English or Spanish.
  4. Patients who are not seeing a primary care physician at the clinic that day.
  5. Patients who are blind or deaf or cannot hear loud voice even with hearing aids.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Project Manager 718-430-3835 emmeline.ayers@einstein.yu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03816644
Other Study ID Numbers  ICMJE 2018-9140
UG3NS105565 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Data will be available within 1 year of study completion.
Access Criteria: Data access requests will be reviewed by the PI and Steering Committee. Requestors will be required to sign a Data Access Agreement.
Responsible Party Joe Verghese, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Joe Verghese, MBBS Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP