SCIO: Sample Collection and Instruction Optimization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feedback usability
研究概览
简要总结
The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.
详细描述
Participants are asked to try a novel first-void urine collection device and give feedback on the instructions and usability of the device through a questionnaire. Further, only the volume of the collected sample is measured. A first group of 30 participants (15 men and 15 women) will be asked for a one-time visit. If any substantial changes need to be made based on the results of the questionnaire, a second group of 30 participants will be asked to evaluate the adapted version.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Naïve to first-void urine collection (standard urine cup is allowed)
- •Able to understand the information brochure and what the study is about
排除标准
- 未提供
研究组 & 干预措施
First-void urine collection
Use of first-void urine device and filling out questionnaire on the instructions for use and the usability after collection.
干预措施: First-void urine collection device (Device)
结局指标
主要结局
Feedback usability
时间窗: Immediately after use of the first-void urine collection device by participants
Collected data on the usability through questionnaire
Feedback instructions for use
时间窗: Immediately after use of the first-void urine collection device by participants
Data collected on the instructions for use through questionnaire
次要结局
- Volume first-void urine collected(Baseline (single visit))
研究者
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen