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

Completed
Conditions
Mild Cognitive Impairment
Dementia
Interventions
Behavioral: eSAGE testing
Behavioral: neuropsychological testing
Registration Number
NCT02544074
Lead Sponsor
Ohio State University
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
69
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Smartphone eSAGE score of 13eSAGE testingParticipants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing.
eSAGE score of 2neuropsychological testingParticipants who score a 2 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 11neuropsychological testingParticipants who score an 11 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 14neuropsychological testingParticipants who score a 14 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 22neuropsychological testingParticipants who score a 22 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 6neuropsychological testingParticipants who score a 6 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 3neuropsychological testingParticipants who score a 3 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 10neuropsychological testingParticipants who score a 10 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 13neuropsychological testingParticipants who score a 13 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 15neuropsychological testingParticipants who score a 15 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 18neuropsychological testingParticipants who score a 18 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 4neuropsychological testingParticipants who score a 4 on the eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 21eSAGE testingParticipants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing.
eSAGE score of 19neuropsychological testingParticipants who score a 19 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 8neuropsychological testingParticipants who score an 8 on the eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 17eSAGE testingParticipants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing.
eSAGE score of 9neuropsychological testingParticipants who score a 9 on the eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 15eSAGE testingParticipants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 19eSAGE testingParticipants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing.
eSAGE score of 12neuropsychological testingParticipants who score a 12 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 16neuropsychological testingParticipants who score a 16 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 17neuropsychological testingParticipants who score a 17 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 20neuropsychological testingParticipants who score a 20 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 21neuropsychological testingParticipants who score a 21 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 7neuropsychological testingParticipants who score a 7 on the eSAGE. Interventions include neuropsychological testing.
eSAGE score of 5neuropsychological testingParticipants who score a 5 on the eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 14eSAGE testingParticipants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 16eSAGE testingParticipants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 18eSAGE testingParticipants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 20eSAGE testingParticipants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing.
Smartphone eSAGE score of 22eSAGE testingParticipants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.
Primary Outcome Measures
NameTimeMethod
eSAGE Score Compared to the Sum of the Neuropsychological Measures.3 Hours

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.

Secondary Outcome Measures
NameTimeMethod
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score3 hours

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.

eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score3 hours

The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.

eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score3 hours

The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.

eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score3 hours

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.

eSAGE Score Compared to the Paper SAGE Score3 hours

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.

eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score3 hours

The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.

eSAGE Score Compare to the FAS Verbal Fluency Task Score3 hours

The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.

eSAGE Score Compared to the Boston Naming Test Score3 hours

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.

eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score3 hours

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.

Trial Locations

Locations (1)

The Ohio State University

🇺🇸

Columbus, Ohio, United States

The Ohio State University
🇺🇸Columbus, Ohio, United States
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