Feasibility, Safety and Effectiveness of Intrathecal Pump Refills at Home: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Physician safety
研究概览
简要总结
The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient receives intrathecal drug therapy
- •Patient is at least 18 years old
- •Native French-or Dutch speaking persons.
排除标准
- •Patients < 18 years old.
- •No native Dutch or French speaking persons.
结局指标
主要结局
Physician safety
时间窗: Once, at the moment of the study visit, immediately after the pump refill
A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.
Patient safety
时间窗: Once, at the moment of the study visit, immediately after the pump refill
A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.
Successful pump refill
时间窗: Once, at the moment of the study visit, immediately after the pump refill
A binary variable to indicate success or failure of this intervention, reported by the physician.
Patient satisfaction
时间窗: Once, at the moment of the study visit, immediately after the pump refill
A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.
次要结局
- Environmental safety(Once, at the moment of the study visit, immediately after the pump refill)
- Adverse events(Once, at the moment of the study visit, immediately after the pump refill)
- Quality of teleconsultant connection by physician(Once, at the moment of the study visit, immediately after the pump refill)
- Time burden for physician(Once, at the moment of the study visit, immediately after the pump refill)
- An objective confirmation of correct injection in the pump by ultrasound.(Once, at the moment of the study visit, immediately after the pump refill)
- Patient feasibility(Once, at the moment of the study visit, immediately after the pump refill)
- Quality of teleconsultant connection by teleconsultant(Once, at the moment of the study visit, immediately after the pump refill)
- Physician feasibility(Once, at the moment of the study visit, immediately after the pump refill)
- Time burden for teleconsultant(Once, at the moment of the study visit, immediately after the pump refill)
- Patient preference(Once, at the moment of the study visit, immediately after the pump refill)
- Clean, sterile procedure(Once, at the moment of the study visit, immediately after the pump refill)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel