Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Patient Comfort
研究概览
简要总结
The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable.
Eighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Only the statistician will be masked to the acquired data.
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
- •Actively receiving Intrathecal drug delivery
- •Stable medication dosage for at least 3 months
- •Dutch, French or English speaking adults
排除标准
- •Life expectancy < 6 months
- •Patients planned for but not yet received Intrathecal drug delivery implant
- •No residence in Belgium
结局指标
主要结局
Patient Comfort
时间窗: At baseline and immediately after each intervention.
Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental and social dimension. Responses are rated on a four-point Likert scale ranging from "strongly disagree" to "strongly agree". Some items are reverse scored during data processing, with higher overall scores indicating greater levels of comfort.
次要结局
- Quality of life(At baseline and immediately after each intervention.)
- Health-related quality of life(At baseline and immediately after each intervention.)
- Pain intensity(At baseline and immediately after each intervention.)
- Pain interference(At baseline and immediately after each intervention.)
- Stress(5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.)
- Anxiety(At baseline and immediately after each intervention.)
- Self-efficacy(At baseline and immediately after each intervention.)
- Caregiver burden(At baseline and immediately after each intervention.)
- Patient satisfaction(Immediately after each refill procedure at home (intervention).)
- Tele-monitoring quality(Immediately after each refill procedure at home (intervention).)
- Duration of refill(Immediately after each intervention.)
- Safety of the refill procedure at home(Immediately after each refill procedure at home (intervention).)
- Health expenditure(Four weeks after the first and second intervention.)
- Patient preference(Immediately after the final study intervention)
- Discrete choice experiment(Immediately after the final study intervention)
研究者
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel