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

• ClinicalTrials.gov Identifier: NCT03816644
• Recruitment Status: Recruiting
• First Posted: January 25, 2019
• Last Update Posted: June 16, 2020
• Sponsor: Albert Einstein College of Medicine
• 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: January 22, 2019
• First Posted Date: January 25, 2019
• Last Update Posted Date: June 16, 2020
• Actual Study Start Date: May 28, 2019
• Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: 5-Cog Battery for Detecting Cognitive Impairment and Dementia
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Screening

Condition

• Dementia
• Cognitive Impairment
• Mild Cognitive Impairment
• Neurocognitive Disorders

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 24, 2019): 1200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2022
• Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Project Manager; 718-430-3835; emmeline.ayers@einstein.yu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03816644
• Other Study ID Numbers: 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

• 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: Albert Einstein College of Medicine
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Joe Verghese, MBBS; Albert Einstein College of Medicine

• PRS Account: Albert Einstein College of Medicine
• Verification Date: April 2020