A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Successful self administration of romiplostim
研究概览
简要总结
Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.
详细描述
This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim,
- •(2) has received HAT pack training,
- •(3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training,
- •(4) patient provides informed consent.
排除标准
- •No exclusion criteria for this observational study
结局指标
主要结局
Successful self administration of romiplostim
时间窗: First Standard of Care visit post Home Administration Training (range 2-8 weeks)
to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack.
次要结局
- Accuracy in administering the prescribed dose of romiplostim(First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment))
- Injects romiplostim(First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment))
- Administers romiplostim(Follow up visits (up to 16 weeks post enrolment))
- successful reconstitution of romiplostim(First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment))