A Feasibility Study of Electronic Neurocognitive Screening Tools in Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in score between the BrainCheck battery and the pen and paper assessments
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: BrainCheck Cognitive Assessment (Behavioral)
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.
干预措施: Cognitive Assessment (Procedure)
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.
干预措施: BrainCheck Cognitive Assessment (Behavioral)
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.
干预措施: Cognitive Assessment (Procedure)
结局指标
主要结局
Difference in score between the BrainCheck battery and the pen and paper assessments
时间窗: Up to 1 year
Will be calculated along with 95% CIs.
Average time to complete the pen and paper assessment
时间窗: Up to 1 year
Will be calculated along with a 95% CI.
Difference in completion rate between the BrainCheck battery and paper and pen assessment
时间窗: Up to 1 year
Will be calculated along with 95% CIs.
Difference in time to completion between the BrainCheck battery and the pen and paper assessment
时间窗: Up to 1 year
Will be calculated along with 95% CIs.
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)
时间窗: Up to 1 year
Will be calculated along with 95% CIs.
Completion rate of the BrainCheck battery
时间窗: Up to 1 year
Will be calculated along with a 95% confidence interval (CI).
Average time to complete the BrainCheck battery
时间窗: Up to 1 year
Will be calculated along with a 95% CI.
Completion rate of the pen and paper assessment
时间窗: Up to 1 year
Will be calculated along with a 95% CI.
次要结局
未报告次要终点