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临床试验/NCT05301907
NCT05301907已完成不适用

Survey Among Healthcare Professionals and MS Patients/Caregivers in Selected European Countries to Evaluate the Knowledge Required for the Safe Use of Mayzent

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2021年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
335
试验地点
1
主要终点
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.

研究概览

简要总结

Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.

详细描述

The survey- based study was conducting amongst HCPs and patients/caregivers in selected European countries including Germany, Netherlands, Nordics (Denmark, Sweden), Spain and Croatia, plus Canada, to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

入选标准

  • Physicians were considered eligible for the survey if they meet the following screening criteria:
  • Care for relapsing MS (RMS) patients
  • Personally prescribed disease modifying therapies to MS patients, and;
  • Have prescribed Mayzent (siponimod) in at least 1 SPMS patient.
  • Nurses were considered eligible for the survey if they:
  • Provide supportive care for RMS patients
  • Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient.
  • Patient inclusion criteria include:
  • - Had initiated onto Mayzent (siponimod) to treat their MS since reimbursement

排除标准

  • 未提供

结局指标

主要结局

Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.

时间窗: Throughout study completion, an average of 3 years

Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected

Knowledge and understanding of the HCPs as per detailed in the educational information provided

时间窗: Throughout study completion, an average of 3 years

Knowledge and understanding of the HCPs as per detailed in the educational information provided relating to: * The appropriate initiation * Specific safety measures when treating patients with Mayzent (siponimod) * Steps when treating patients with sinus bradycardia, 1st/2nd degree AV block or history of myocardial infarction or health failure * Procedures for the management of infections, macular edema, skin malignancies and pregnancy considerations. * Steps in ophthalmology checklist, managing infection risk, pregnancy, liver function and skin examinations Knowledge and understanding was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided

时间窗: Throughout study completion, an average of 3 years

Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided relating to: * Specific safety measures when being treated with Mayzent (siponimod) * Side effects and potential risks Knowledge and understanding was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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