5-Cog Battery for Detecting Cognitive Impairment and Dementia (5-Cog)
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|ClinicalTrials.gov Identifier: NCT03816644|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : December 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Dementia Cognitive Impairment Mild Cognitive Impairment Neurocognitive Disorders||Other: 5-Cog Other: Health Literacy & Grip Assessment||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||1201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia|
|Actual Study Start Date :||May 28, 2019|
|Actual Primary Completion Date :||December 15, 2022|
|Estimated Study Completion Date :||September 15, 2023|
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-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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
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:
- "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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816644
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Joe Verghese, MBBS||Albert Einstein College of Medicine|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Joe Verghese, Professor, Neuorology, Albert Einstein College of Medicine|
|Other Study ID Numbers:||
UG3NS105565 ( U.S. NIH Grant/Contract )
|First Posted:||January 25, 2019 Key Record Dates|
|Last Update Posted:||December 22, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (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.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Mild Cognitive Impairment
Central Nervous System Diseases
Nervous System Diseases