5-Cog Battery for Detecting Cognitive Impairment and Dementia

NCT03816644 | Completed Results

• 2 other identifiers: 2018-9140UG3NS105565
• Study Type: interventional
• Target: 1,201
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Cognitive Impairment; Mild Cognitive Impairment; Neurocognitive Disorders

Keywords

Cognitive screening; Primary care; Dementia; Cognitive Impairment; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• New Occurrence 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. The endpoint is the number of participants who received 1 or more of the following orders: 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.

  90 days after the participant is randomized

Secondary Outcomes (1)

• New Occurrence of in Health Care Utilization

  6 months after the participant is randomized

Other Outcomes (3)

• Cost-effectiveness

  6 months after the participant is randomized

• Change in Health Care Utilization

  12 months after the participant is randomized

• Cost-effectiveness

  12 months after the participant is randomized

Study Arms (2)

5-Cog

EXPERIMENTAL

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

Health Literacy & Grip Assessment

ACTIVE COMPARATOR

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

Interventions

5-Cog OTHER

The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.

5-Cog

Health Literacy & Grip Assessment OTHER

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.

Health Literacy & Grip Assessment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (3)

• 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 BACKGROUND

• Verghese J, Chalmer R, Stimmel M, Weiss E, Zwerling J, Malik R, Rasekh D, Ansari A, Corriveau RA, Ehrlich AR, Wang C, Ayers E. Non-literacy biased, culturally fair cognitive detection tool in primary care patients with cognitive concerns: a randomized controlled trial. Nat Med. 2024 Aug;30(8):2356-2361. doi: 10.1038/s41591-024-03012-8. Epub 2024 Jun 4.

  PMID: 38834847 DERIVED

• 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.

  PMID: 35603666 DERIVED

Related Links

• The Consortium for Detecting Cognitive Impairment, Including Dementia

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Neurocognitive Disorders

Interventions

Health Literacy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Consumer Health Information; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Joe Verghese
• Organization: Albert Einstein College of Medicine

joe.verghese@einsteinmed.edu

7184303808

Study Officials

• Joe Verghese, MBBS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: May 28, 2019
• Primary Completion: December 15, 2022
• Study Completion: March 15, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)