Trial Outcomes & Findings for 5-Cog Battery for Detecting Cognitive Impairment and Dementia (NCT NCT03816644)

Last Updated: 2024-01-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1201 participants

Primary outcome timeframe

90 days after the participant is randomized

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	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. 5-Cog: The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.	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. 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.
Overall Study STARTED	599	602
Overall Study COMPLETED	592	600
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

5-Cog Battery for Detecting Cognitive Impairment and Dementia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-Cog n=599 Participants 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. 5-Cog: The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.	Health Literacy & Grip Assessment n=602 Participants 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. 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.	Total n=1201 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	599 Participants n=5 Participants	602 Participants n=7 Participants	1201 Participants n=5 Participants
Age, Continuous	72.88 years STANDARD_DEVIATION 6.38 • n=5 Participants	72.64 years STANDARD_DEVIATION 6.67 • n=7 Participants	72.76 years STANDARD_DEVIATION 6.52 • n=5 Participants
Sex: Female, Male Female	431 Participants n=5 Participants	434 Participants n=7 Participants	865 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	168 Participants n=7 Participants	336 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	323 Participants n=5 Participants	344 Participants n=7 Participants	667 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	275 Participants n=5 Participants	258 Participants n=7 Participants	533 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	305 Participants n=5 Participants	280 Participants n=7 Participants	585 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	59 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) More than one race	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	183 Participants n=5 Participants	220 Participants n=7 Participants	403 Participants n=5 Participants
Region of Enrollment United States	599 participants n=5 Participants	602 participants n=7 Participants	1201 participants n=5 Participants
Education years	11.24 years STANDARD_DEVIATION 4.10 • n=5 Participants	10.95 years STANDARD_DEVIATION 4.26 • n=7 Participants	11.09 years STANDARD_DEVIATION 4.18 • n=5 Participants
Language of test administration English	339 Participants n=5 Participants	342 Participants n=7 Participants	681 Participants n=5 Participants
Language of test administration Spanish	260 Participants n=5 Participants	260 Participants n=7 Participants	520 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days after the participant is randomized

Outcome measures

Outcome measures
Measure	5-Cog n=599 Participants 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. 5-Cog: The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.	Health Literacy & Grip Assessment n=602 Participants 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. 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.
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.	111 Participants	41 Participants

SECONDARY outcome

Timeframe: 6 months after the participant is randomized

Utilization is defined in terms of emergency room visits and hospitalizations following the screening visit. The number of participants who went to the emergency room or had a hospitalization in the 6 months following the screening visit are presented in aggregate.

Outcome measures

Outcome measures
Measure	5-Cog n=599 Participants 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. 5-Cog: The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.	Health Literacy & Grip Assessment n=602 Participants 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. 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.
New Occurrence of in Health Care Utilization	106 Participants	96 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months after the participant is randomized

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months after the participant is randomized

Outcome measures

Outcome data not reported

Adverse Events

5-Cog

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Literacy & Grip Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joe Verghese

Albert Einstein College of Medicine

Phone: 7184303808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place