电子神经认知工具用于筛查接受肝脏手术的患者的心理能力
电子神经认知筛查工具在手术中的可行性研究
This trial studies how well electronic neurocognitive tools work in screening for mental capability in patients who are undergoing liver surgery. Using electronic neurocognitive screening tools may help to better assess mental impairment.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. Evaluate feasibility of the electronic batteries, measured by the completion rate and time to completion of the batteries.
SECONDARY OBJECTIVES:
I. Comparison of the completion rate and time to completion between the written and electronic batteries.
II. Comparison of the scoring distribution between the screening tools.
EXPLORATORY OBJECTIVES:
I. Assess if a history of mental or cognitive illness or ongoing treatment with neuropsychiatric medications impact the ability to complete written and/or electronic neurocognitive screening.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen cognitive assessment within 2 months prior to surgery and within 2 months after surgery.
GROUP II: Patients receive the paper and pen cognitive assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- M D Anderson Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician.
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group I (BrainCheck and paper and pen cognitive assessment)
Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen assessment 2 months prior to surgery and within 2 months after surgery. |
Receive BrainCheck cognitive assessment
其他名称：
Receive pen and paper cognitive assessment |
|
有源比较器：Group II (pen and paper and BrainCheck cognitive assessment)
Patients receive the paper and pen assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery. |
Receive BrainCheck cognitive assessment
其他名称：
Receive pen and paper cognitive assessment |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Completion rate of the BrainCheck battery
大体时间：Up to 1 year
|
Will be calculated along with a 95% confidence interval (CI). |
Up to 1 year
|
|
Completion rate of the pen and paper assessment
大体时间：Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Average time to complete the BrainCheck battery
大体时间：Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Average time to complete the pen and paper assessment
大体时间：Up to 1 year
|
Will be calculated along with a 95% CI. |
Up to 1 year
|
|
Difference in completion rate between the BrainCheck battery and paper and pen assessment
大体时间：Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
|
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
大体时间：Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
|
Difference in score between the BrainCheck battery and the pen and paper assessments
大体时间：Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
|
Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of the electronic battery compared to the validated St. Louis University Mental Status Examination (SLUMS)
大体时间：Up to 1 year
|
Will be calculated along with 95% CIs. |
Up to 1 year
|
合作者和调查者
调查人员
- 首席研究员：Timothy Newhook, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.