5-Cog Battery for Detecting Cognitive Impairment and Dementia

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT03816644

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

1,200

Enrollment

Location

Arms

38.1

Anticipated Duration (Months)

31.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Cognitive Impairment Mild Cognitive Impairment Neurocognitive Disorders	Other: 5-Cog Other: Health Literacy & Grip Assessment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

May 28, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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'.
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.	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.

Arm

Intervention/Treatment

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.

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'.

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.

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.

Outcome Measures

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. [90 days after the participant is randomized]
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 [6 months after the participant is randomized]
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.

Other Outcome Measures

Cost-effectiveness [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.