Patient Reported Outcome Study on Long Term LoFric Users
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 主要终点
- Patient perception of therapy
研究概览
简要总结
A prospective, observational cohort study evaluating Patient Reported Outcome in subjects with a long term experience from intermittent catheterization using the LoFric catheter. Prescription and use of LoFric catheters fall within current practice and is not dictated within this Non-Interventional Study.
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
- •Provision of informed consent.
- •Female or male aged 18 years or older at time of signing informed consent.
- •Use of LoFric catheters for urethral intermittent catheterization for ≥ 6 years and currently using LoFric.
- •Able to read and write.
- •By investigator judged as able to comprehend and answer study questionnaires.
排除标准
- •Use of other catheter brand(s) than LoFric for > 8 weeks in total during the past 12 months.
- •Simultaneous participation in any interfering clinical study as judged by the investigator.
- •Involvement in the planning and/or conduct of the NIS (applies to both Wellspect HealthCare staff and staff at the study site).
- •Previous enrolment in the present NIS.
结局指标
主要结局
Patient perception of therapy
时间窗: 5 years
PRO variables Four questions regarding perception of subject's intermittent catheter therapy. Response on a 4 graded scale; Strongly agree, agree, disagree, strongly disagree. Changes will be followed during study period.
Compliance/non-compliance to LoFric
时间窗: 5 years
PRO variables Type of catheter used collected during study period
Document urological complications
时间窗: 5 years
Other urological complications last 12 months
Quality of Life Data
时间窗: 5 years
EQ-5D variables QoL data will be collected at each measuring point using the validated instrument EQ-5D-3L (EQ-5D). The EQ-5D, consisting of a questionnaire and a visual analogue scale (VAS), is a standardized health-related quality of life questionnaire developed by the EuroQoL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The VAS is a self-rated health status scale and records the subject's perception of his/her own current overall health and can be used to monitor changes over time. The questionnaire is a self-reported description of the subject's current health in 5 dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to grade their own current level of function in each dimension on a three-graded scale (i.e. no problems, some problems or severe problems) and the combination of these creates a unique health state.
Patient perception of LoFric
时间窗: 5 years
PRO variables Eight questions regarding perception of subject's catheter. Response on a 4 graded scale; Strongly agree, agree, disagree, strongly disagree. Changes will be followed during study period.
次要结局
未报告次要终点