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临床试验/NCT01118182
NCT01118182已完成不适用

Use of a Traumatic Brain Injury (TBI) Screen in a Veteran Mental Health Population: Prevalence, Validation, and Psychiatric Outcomes

VA Eastern Colorado Health Care System1 个研究点 分布在 1 个国家目标入组 1,810 人开始时间: 2009年6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
1,810
试验地点
1
主要终点
Ohio State University TBI Identification Method (OSU TBI-ID)

研究概览

简要总结

The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).

详细描述

The primary aims of this study are to: 1) Establish the concurrent criterion-related validity of four traumatic brain injury (TBI) screening questions (TBI-4) using the Ohio State University TBI Identification Method (OSU TBI-ID) and 2) Establish the concurrent criterion-related validity of the TBI-4 with the addition of detailed information elicited by the four questions. Secondary aims include: 1) Determining if the addition of detailed information elicited by the TBI-4 results in increased specificity; 2) Determining whether the prevalence of traumatic brain injury (TBI) in this sample is concordant with previous research; and 3) Determining whether psychiatric outcomes are worse for veterans with traumatic brain injury (TBI) than those with no traumatic brain injury(TBI).

Primary Hypotheses:

Hypothesis 1a: The sensitivity and specificity of the TBI-4 will be significantly greater than 0.75 and 0.80, respectively.

Hypothesis 1b: The sensitivity and specificity of the TBI-4 with the addition of detailed information elicited by these questions (i.e., free text information entered by the clinician who administered the TBI-4) will be significantly greater than 0.75 and 0.80, respectively.

Secondary Hypotheses:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Veteran must be at least 18 years of age.
  • Veteran must have had a mental health intake no earlier than January of 2007.

排除标准

  • Failure to provide informed consent as evidenced by inability to respond to the above stated questions.
  • No Mental Health Intake note in the medical record.
  • Presence of a Mental Health Intake note in the computer which does not contain the TBI-4

结局指标

主要结局

Ohio State University TBI Identification Method (OSU TBI-ID)

时间窗: 1 day

Structured clinical interview used as the gold standard for establishing a lifetime history of TBI

次要结局

未报告次要终点

研究者

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

Lisa Brenner

Director, VA VISN 19 Mental Illness Research Education and Clinical Center (MIRECC)

VA Eastern Colorado Health Care System

研究点 (1)

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