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

Primary Purpose

Dementia, Cognitive Impairment, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-Cog
Health Literacy & Grip Assessment
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dementia focused on measuring Cognitive screening, Primary care, Dementia, Cognitive Impairment, Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5-Cog

Health Literacy & Grip Assessment

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in dementia care-A composite endpoint including new cognitive diagnoses, laboratory investigations related to cognitive impairment, new dementia prescriptions, and cognitive related referrals.
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.

Secondary Outcome Measures

Change in health care utilization
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.

Full Information

First Posted
January 22, 2019
Last Updated
October 14, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03816644
Brief Title
5-Cog Battery for Detecting Cognitive Impairment and Dementia
Acronym
5-Cog
Official Title
5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Impairment, Mild Cognitive Impairment, Neurocognitive Disorders
Keywords
Cognitive screening, Primary care, Dementia, Cognitive Impairment, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-Cog
Arm Type
Experimental
Arm 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 Title
Health Literacy & Grip Assessment
Arm Type
Active Comparator
Arm 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(s)
5-Cog
Intervention Description
The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.
Intervention Type
Other
Intervention Name(s)
Health Literacy & Grip Assessment
Intervention 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.
Primary Outcome Measure Information:
Title
Change in dementia care-A composite endpoint including new cognitive diagnoses, laboratory investigations related to cognitive impairment, new dementia prescriptions, and cognitive related referrals.
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.
Time Frame
90 days after the participant is randomized
Secondary Outcome Measure Information:
Title
Change in health care utilization
Description
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
Time Frame
6 months after the participant is randomized
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness
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.
Time Frame
6 months after the participant is randomized
Title
Change in health care utilization
Description
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
Time Frame
12 months after the participant is randomized
Title
Cost-effectiveness
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.
Time Frame
12 months after the participant is randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: "Dementia" "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 Galantamine = Razadyne Donepezil and Memantine = Namzaric Adults who are permanent residents of a nursing facility. Patients who do not speak English or Spanish. Patients who are not seeing a primary care physician at the clinic that day. Patients who are blind or deaf or cannot hear loud voice even with hearing aids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Verghese, MBBS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 1 year of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the PI and Steering Committee. Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
29808583
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.
Results Reference
background
PubMed Identifier
35603666
Citation
Chalmer R, Ayers E, Weiss EF, Malik R, Ehrlich A, Wang C, Zwerling J, Ansari A, Possin KL, Verghese J. The 5-Cog paradigm to improve detection of cognitive impairment and dementia: clinical trial protocol. Neurodegener Dis Manag. 2022 Aug;12(4):171-184. doi: 10.2217/nmt-2021-0043. Epub 2022 May 23.
Results Reference
derived
Links:
URL
https://www.detectcid.org/
Description
The Consortium for Detecting Cognitive Impairment, Including Dementia

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5-Cog Battery for Detecting Cognitive Impairment and Dementia

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