NCT01601080已完成不适用
REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Patient Adherence
研究概览
简要总结
This is an observational, retrospective, UK & Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland
- •Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device
- •Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care
- •Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland)
- •Be willing to give consent for their adherence data to be captured in the audit
排除标准
- •Patients who do not fulfill entirely the inclusion criteria as well as the following:
- •Discontinued Rebif before 24 months of treatment
- •Unable or unwilling to give consent for their adherence data to be captured in the audit
结局指标
主要结局
Patient Adherence
时间窗: 24 months
Percentage "RebiSmart measured" patient adherence to Rebif® injections
次要结局
- Patient Adherence(12 months)
- Difference in patient adherence over time(12 months)
- Medication Possession Ratio(24 months)
- Adherence of patient subgroups(24 months)
- Patient Adherence in the UK versus Ireland(24 months)
- Device Comfort Settings(12 months)
研究者
研究点 (1)
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