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临床试验/NCT01195857
NCT01195857已完成不适用

Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration

Merck KGaA, Darmstadt, Germany0 个研究点目标入组 100 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse

研究概览

简要总结

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.

Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.

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

入选标准

  • Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device
  • Be under regular review by a MS nurse
  • Be aged 18 or above
  • Be willing and able to participate in the trial and to have provided written informed consent

排除标准

  • Receiving disease modifying therapy other than Rebif
  • Receiving Rebif but not using the Rebiject II injection device
  • Do not self inject
  • Are unable or unwilling to provide informed consent

结局指标

主要结局

Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse

时间窗: up to 6 month

次要结局

  • Correlation with disease control (relapse rate)(up to 6 month)
  • Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist(up to 6 month)
  • Length of time on treatment(up to 6 month)
  • Cognitive impairment(up to 6 month)
  • Correlation with recent training within the last 6 months(up to 6 month)
  • Presence of injection site reactions(up to 6 month)

研究者

申办方类型
Industry
责任方
Sponsor

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