NCT01316484已完成不适用
Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary
Tranzyme, Inc.4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Qualitative, Content Analysis of Cognitive Debriefing Data
研究概览
简要总结
The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has Type 1 or Type 2 diabetes mellitus
- •Subject is 18 to 70 years old
- •Subject has chronic, active symptoms of gastroparesis for at least the past three months
- •Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule
- •Subject can speak and read English
- •Subject is able to give his/her informed consent
排除标准
- •Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit
结局指标
主要结局
Qualitative, Content Analysis of Cognitive Debriefing Data
时间窗: 90-minute interview
The cognitive debriefing data will be content analyzed for patient understanding of the concepts in the questionnaire and interpretation of the items' content.
次要结局
未报告次要终点
研究者
研究点 (4)
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