CP382 - Intermittent Catheter (IC) PRO Panel Plan
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Number of IC products used by subjects.
研究概览
简要总结
The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects using an intermittent catheter as their primary bladder emptying method.
详细描述
The registry's objective is to allow for insights into the needs of people with intimate healthcare needs from the user's perspective and experience. The registry will provide valuable information from the participants' perspective on several issues including, but not limited to product use and satisfaction, frequency of urinary tract infections, and quality-of-life related to IC use. The registry will allow for a more user-centric approach when listening and responding to the needs and challenges of IC users.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Willing to give informed consent
- •18 years of age or above
- •Full legal capacity
- •Willing and able (self-assessed) to complete online questionnaires
- •using intermittent catheterization as the primary method for bladder emptying
排除标准
- 未提供
结局指标
主要结局
Number of IC products used by subjects.
时间窗: 5 years
Characterization of a cohort of IC users at point-of-entry to the registry including but not limited to, IC product consumption, user-patterns, prescriptions, and use of supporting products.
The number of urinary tract infections
时间窗: 5 years
Frequency and consequences of urinary tract infections.
The Mental well-being index (WHO-5)
时间窗: 5 years
Quality-of-life (QoL) using the Mental well-being index (WHO-5). The subject has 5 questions asked, with 6 different responses available: "All of the time", "Most of the time", "More than half the time", "less than half the time", "some of the time", and "at no time". The choice of "all of the time" equates to a better well-being than a response of "at no time".
次要结局
未报告次要终点