Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE) (eSAGE)

The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in almost any setting, does not require any staff time to administer and makes it practical to rapidly screen large numbers of individuals in the community or in their home.This trial is being conducted to study the validity of SAGE in a digital format (eSAGE) for cognitive screening.

The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.

Addendum:

The eSAGE was previously validated in an earlier stage of this trial. It was initially designed for tablet use and the exact same test has recently been formatted for smartphone use.

This addendum is being conducted to study the validity of the smartphone eSAGE compared to the tablet eSAGE for cognitive screening.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: neuropsychological testing; Behavioral: eSAGE testing

Detailed Description

Participants will be recruited based on their eSAGE scores and evaluated with neuropsychological testing and medical history to determine their status as normal, mild cognitive impairment, or dementia.

The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.

Addendum:

Subjects will be scheduled for a one time visit where they will be administered both the tablet eSAGE and the smartphone eSAGE. eSAGE tablet scores will be compared to eSAGE smartphone scores to determine if the two formats are equivalent to each other.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from a wide variety of community events including senior centers, health fairs, educational talks to lay public, independent and assisted living facilities, and free memory screens as well as from ambulatory Geriatric or Memory Disorders Clinics. The SAGE cognitive screening tool will be given to all subjects willing to take the test.Participants who complete the SAGE test and meet inclusion and exclusion criteria will be divided into groups based on their initial SAGE scores. Each group will be composed of subjects with the same score. Individuals will be randomly selected from each group and asked to further participate in a one-time clinical evaluation.

Addendum:

Subjects will be recruited from community events and our clinic and research center.

Description

Inclusion Criteria:

• Adults over 49 years old of either gender
• Vision and hearing sufficient for compliance with tests

Exclusion Criteria:

• Diagnosis by a physician of moderate or severe dementia
• Intellectual disability

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

31

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
eSAGE score of 10; Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 11; Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 12; Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 13; Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 14; Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 15; Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 16; Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 17; Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 18; Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 19; Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 20; Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 21; Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 22; Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 9; Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 8; Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 6; Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 7; Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 5; Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 4; Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 3; Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
eSAGE score of 2; Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.	Behavioral: neuropsychological testing; standard neuropsychological testing including brief standardized assessments
Smartphone eSAGE score of 13; Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 14; Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 15; Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 16; Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 17; Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 18; Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 19; Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 20; Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 21; Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
Smartphone eSAGE score of 22; Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.	Behavioral: eSAGE testing; Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eSAGE Score Compared to the Sum of the Neuropsychological Measures.	Analysis will consist of comparing the subject's scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include: Boston Naming Test; Wisconsin Card Sort Task (WCST); Hopkins Verbal Learning Test (HVLT); FAS verbal fluency task; Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests Associations will be investigated using Spearman correlations.	3 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eSAGE Score Compared to the Paper SAGE Score	The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score	The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score	The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Boston Naming Test Score	The investigators will compare the eSAGE scores to the Boston Naming Test score. The Boston Naming Test consists of 60 pictures of nouns that subjects must try to name. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score	The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score	The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations. The investigators will also compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compare to the FAS Verbal Fluency Task Score	The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score	The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. The WAIS III Letter-number test asks subjects to recall a series of numbers in increasing order and letters in alphabetical order. Associations will be investigated using Spearman correlations.	3 hours
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score	The investigators will compare the eSAGE scores to the WAIS III Block Design scores. The WAIS III Block Design requires the replication of red and white designs using three-dimensional colored blocks. Associations will be investigated using Spearman correlations.	3 hours

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Brain Test, Inc.
• Investigators: Principal Investigator: Douglas Scharre, M.D., Ohio State University

Publications and helpful links

General Publications

• Scharre DW, Chang SI, Nagaraja HN, Vrettos NE, Bornstein RA. Digitally translated Self-Administered Gerocognitive Examination (eSAGE): relationship with its validated paper version, neuropsychological evaluations, and clinical assessments. Alzheimers Res Ther. 2017 Jun 27;9(1):44. doi: 10.1186/s13195-017-0269-3.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimated): September 9, 2015

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2014H0039