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临床试验/NCT02544074
NCT02544074已完成不适用

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

Ohio State University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
eSAGE Score Compared to the Sum of the Neuropsychological Measures.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

eSAGE Score Compared to the Sum of the Neuropsychological Measures.

时间窗: 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.

次要结局

  • eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score(3 hours)
  • eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score(3 hours)
  • eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score(3 hours)
  • eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score(3 hours)
  • eSAGE Score Compared to the Paper SAGE Score(3 hours)
  • eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score(3 hours)
  • eSAGE Score Compare to the FAS Verbal Fluency Task Score(3 hours)
  • eSAGE Score Compared to the Boston Naming Test Score(3 hours)
  • eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score(3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Scharre

Professor

Ohio State University

研究点 (1)

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