Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
- Conditions
- Mild Cognitive ImpairmentDementia
- Interventions
- Behavioral: eSAGE testingBehavioral: 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
- Adults over 49 years old of either gender
- Vision and hearing sufficient for compliance with tests
- Diagnosis by a physician of moderate or severe dementia
- Intellectual disability
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Smartphone eSAGE score of 13 eSAGE testing Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing. eSAGE score of 2 neuropsychological testing Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 11 neuropsychological testing Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 14 neuropsychological testing Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 22 neuropsychological testing Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 6 neuropsychological testing Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 3 neuropsychological testing Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 10 neuropsychological testing Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 13 neuropsychological testing Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 15 neuropsychological testing Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 18 neuropsychological testing Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 4 neuropsychological testing Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 21 eSAGE testing Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing. eSAGE score of 19 neuropsychological testing Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 8 neuropsychological testing Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 17 eSAGE testing Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing. eSAGE score of 9 neuropsychological testing Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 15 eSAGE testing Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 19 eSAGE testing Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing. eSAGE score of 12 neuropsychological testing Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 16 neuropsychological testing Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 17 neuropsychological testing Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 20 neuropsychological testing Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 21 neuropsychological testing Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 7 neuropsychological testing Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. eSAGE score of 5 neuropsychological testing Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 14 eSAGE testing Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 16 eSAGE testing Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 18 eSAGE testing Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 20 eSAGE testing Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing. Smartphone eSAGE score of 22 eSAGE testing Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.
- Primary Outcome Measures
Name Time Method 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
Name Time Method eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score 3 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) Score 3 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) Score 3 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) Score 3 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 Score 3 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) Score 3 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 Score 3 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 Score 3 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 Score 3 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.
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Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States
The Ohio State University🇺🇸Columbus, Ohio, United States