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临床试验/NCT05762185
NCT05762185已完成不适用

Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2019年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Variation of BIOSECURE score between baseline and after nurse consultation

研究概览

简要总结

Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
  • Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion
  • Major patient
  • Patient having signed an informed consent

排除标准

  • Minor patient
  • Patient with cognitive impairment diagnosed by a physician
  • Patient under tutorship or curatorship
  • Patient deaf or hard of hearing
  • Patient not fluent in the French language (at the decision of the investigator)

研究组 & 干预措施

nursing consultation

Experimental

干预措施: nursing consultation (Device)

结局指标

主要结局

Variation of BIOSECURE score between baseline and after nurse consultation

时间窗: one day

Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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