<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816644</url>
  </required_header>
  <id_info>
    <org_study_id>2018-9140</org_study_id>
    <secondary_id>UG3NS105565</secondary_id>
    <nct_id>NCT03816644</nct_id>
  </id_info>
  <brief_title>5-Cog Battery for Detecting Cognitive Impairment and Dementia</brief_title>
  <acronym>5-Cog</acronym>
  <official_title>5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the availability of numerous cognitive assessment tools, cognitive impairment related&#xD;
      to dementia is frequently under-diagnosed in primary care settings. The investigators have&#xD;
      developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the&#xD;
      technical, cultural and logistic barriers of current cognitive screens to improve dementia&#xD;
      care in primary care patients with cognitive concerns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the availability of numerous cognitive assessment tools, cognitive impairment related&#xD;
      to dementia is frequently under-diagnosed in primary care settings, and is a more prevalent&#xD;
      problem among older African-Americans and Hispanics than among older whites. Missed detection&#xD;
      delays treatment of reversible conditions as well as provision of support services and&#xD;
      critical planning. To overcome the technical, cultural and logistic barriers of current&#xD;
      cognitive screens and dementia care in primary care settings the investigators have developed&#xD;
      a 5-minute cognitive screen (5-Cog) coupled with a decision tree to identify persons at high&#xD;
      risk of developing dementia in multi-ethnic primary care populations.&#xD;
&#xD;
      The 5-Cog includes the Picture based Memory Impairment Screen (PMIS), Motoric Cognitive Risk&#xD;
      syndrome (MCR), and a brief non-memory picture based test (Symbol Match). The cognitive&#xD;
      assessment will sort patients with 'cognitive impairment' from those with 'no cognitive&#xD;
      impairment'. It is coupled with a decision tree to guide clinicians through the follow up&#xD;
      based on results of the 5-Cog.&#xD;
&#xD;
      The primary objective is to test the ability of the 5-Cog and decision tree paradigm to&#xD;
      improve dementia care in primary care patients with cognitive concerns.&#xD;
&#xD;
      The investigators propose a single-blind, randomized clinical trial (RCT) in 1,200 older&#xD;
      primary care patients with cognitive concerns who will be randomized to receive the 5-Cog&#xD;
      (intervention group) or a 5-minute health literacy and grip assessment (active control&#xD;
      group). Non-physicians will administer the intervention and control assessments in primary&#xD;
      care sites and will provide results for both arms to the treating physician with a decision&#xD;
      tree follow up guide based on the results of the assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">September 15, 2023</completion_date>
  <primary_completion_date type="Actual">December 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dementia care-A composite endpoint including new cognitive diagnoses, laboratory investigations related to cognitive impairment, new dementia prescriptions, and cognitive related referrals.</measure>
    <time_frame>90 days after the participant is randomized</time_frame>
    <description>Dementia care is defined as the occurrence of any of the following endpoints following the screening visit.&#xD;
Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR.&#xD;
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.&#xD;
Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR.&#xD;
Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in health care utilization</measure>
    <time_frame>6 months after the participant is randomized</time_frame>
    <description>Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 months after the participant is randomized</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in health care utilization</measure>
    <time_frame>12 months after the participant is randomized</time_frame>
    <description>Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>12 months after the participant is randomized</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1201</enrollment>
  <condition>Dementia</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Neurocognitive Disorders</condition>
  <arm_group>
    <arm_group_label>5-Cog</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Literacy &amp; Grip Assessment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5-Cog</intervention_name>
    <description>The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.</description>
    <arm_group_label>5-Cog</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Literacy &amp; Grip Assessment</intervention_name>
    <description>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.</description>
    <arm_group_label>Health Literacy &amp; Grip Assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 65 and older.&#xD;
&#xD;
          2. Presence of cognitive or memory concerns expressed by patient, caregiver, health care&#xD;
             provider or other source who knows the patient.&#xD;
&#xD;
          3. Registered as patient at Montefiore Medical Center and have a primary care doctor&#xD;
             appointment that day.&#xD;
&#xD;
          4. Able to hear and see well enough to complete intervention or control assessments.&#xD;
&#xD;
          5. English or Spanish speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior diagnosis of dementia or MCI as ascertained by ICD-10 codes or the documentation&#xD;
             of prescription for anti-dementia medications in EMR. Patients with a diagnosis&#xD;
             containing any of the following terms will be excluded:&#xD;
&#xD;
               1. &quot;Dementia&quot;&#xD;
&#xD;
               2. &quot;Mild Cognitive Impairment&quot;&#xD;
&#xD;
               3. &quot;Alzheimer's Disease&quot;&#xD;
&#xD;
               4. &quot;Creutzfeldt-Jakob Disease&quot;&#xD;
&#xD;
               5. &quot;Major Neurocognitive Disorder&quot;&#xD;
&#xD;
               6. &quot;Minor Neurocognitive Disorder&quot;&#xD;
&#xD;
             Patients with any of the following medications documented in their EMR will be&#xD;
             excluded (generic = brand):&#xD;
&#xD;
               1. Donepezil = Aricept&#xD;
&#xD;
               2. Memantine = Namenda&#xD;
&#xD;
               3. Rivastigmine = Exelon&#xD;
&#xD;
               4. Galantamine = Razadyne&#xD;
&#xD;
               5. Donepezil and Memantine = Namzaric&#xD;
&#xD;
          2. Adults who are permanent residents of a nursing facility.&#xD;
&#xD;
          3. Patients who do not speak English or Spanish.&#xD;
&#xD;
          4. Patients who are not seeing a primary care physician at the clinic that day.&#xD;
&#xD;
          5. Patients who are blind or deaf or cannot hear loud voice even with hearing aids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joe Verghese, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein College of Medicine</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.detectcid.org/</url>
    <description>The Consortium for Detecting Cognitive Impairment, Including Dementia</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>29808583</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>December 21, 2022</last_update_submitted>
  <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein College of Medicine</investigator_affiliation>
    <investigator_full_name>Joe Verghese</investigator_full_name>
    <investigator_title>Professor, Neuorology</investigator_title>
  </responsible_party>
  <keyword>Cognitive screening</keyword>
  <keyword>Primary care</keyword>
  <keyword>Dementia</keyword>
  <keyword>Cognitive Impairment</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Neurocognitive Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 1 year of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the PI and Steering Committee. Requestors will be required to sign a Data Access Agreement.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816644
org study id: 2018-9140
secondary id: UG3NS105565
nct id: NCT03816644
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: 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
description: Dementia care is defined as the occurrence of any of the following endpoints following the screening visit.
Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR.
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.
Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR.
Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.
measure: Change in health care utilization
time frame: 6 months after the participant is randomized
description: Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
measure: Cost-effectiveness
time frame: 6 months after the participant is randomized
description: 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.
measure: Change in health care utilization
time frame: 12 months after the participant is randomized
description: Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
measure: Cost-effectiveness
time frame: 12 months after the participant is randomized
description: 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.
arm group label: 5-Cog
arm group type: Experimental
description: 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.
arm group label: Health Literacy & Grip Assessment
arm group type: Active Comparator
description: 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 type: Other
intervention name: 5-Cog
description: The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.
arm group label: 5-Cog
intervention type: Other
intervention name: Health Literacy & Grip Assessment
description: 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.
arm group label: Health Literacy & Grip Assessment
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joe Verghese, MBBS
role: Principal Investigator
affiliation: Albert Einstein College of Medicine
facility: 
country: United States
url: https://www.detectcid.org/
description: The Consortium for Detecting Cognitive Impairment, Including Dementia
citation: 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.
PMID: 29808583
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein College of Medicine
investigator full name: Joe Verghese
investigator title: Professor, Neuorology
mesh term: Dementia
mesh term: Cognitive Dysfunction
mesh term: Neurocognitive Disorders
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Data will be available within 1 year of study completion.
ipd access criteria: Data access requests will be reviewed by the PI and Steering Committee. Requestors will be required to sign a Data Access Agreement.