NCT03732443撤回不适用
Translation and Validation of the Family Confusion Assessment Method (FAM-CAM) Into German for the Detection of Delirium in Critically Ill Patients
Technical University of Munich1 个研究点 分布在 1 个国家开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Cohen's Kappa Coefficient
研究概览
简要总结
Validation and Translation of the Family Confusion Assessment Method (FAM-CAM) into German according to Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes of the International Society for Pharmaoeconomics and Outcome Research and comparison to CAM-ICU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Intensive Care Stay ≥ 48 hours
- •Expected RASS ≥ 3
- •Communication possible in German (minimum of C1 level of Common European Framework of Reference for Languages)
排除标准
- •preexisting psychosis, dementia or depression
结局指标
主要结局
Cohen's Kappa Coefficient
时间窗: During a family visit which is not the first while treated in intensive care (an median of 10 days)
Cohen's Kappa coefficient comparing the Family Confusion Assessment Method and the Confusion Assessment Method for Intensive Care Unit
次要结局
- Specificity of FAM-CAM(During a family visit which is not the first while treated in intensive care (an median of 10 days))
- Sensitivity of FAM-CAM(During a family visit which is not the first while treated in intensive care (an median of 10 days))
- NPV of FAM-CAM(During a family visit which is not the first while treated in intensive care (an median of 10 days))
- PPV of FAM-CAM(During a family visit which is not the first while treated in intensive care (an median of 10 days))
研究者
研究点 (1)
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