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临床试验/DRKS00022771
DRKS00022771已完成2 期

Communication, Coordination und Security for People with Multiple Sclerosis - COCOS-MS

niversität zu Köln0 个研究点目标入组 80 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Patients with:
  • 1) Highly active MS with an indication for an escalating immunotherapeutic agent and being treated with such, and at least one of the following: age = 50, expanded disability status scale (EDSS) = 5 (Subgroup 1)
  • 2a) Primary or secondary chronic progressive MS, age = 18, EDSS 4-7, no immunotherapeutic treatment options (Subgroup 2a)
  • 2b) Primary or secondary chronic progressive MS, age = 18, EDSS > 7 (Subgroup 2b)
  • - residence in the administrative district of Cologne
  • AND one of the following criteria applies:
  • - full command in understanding, reading, responding of German language skills and ability to give written informed consent
  • - if a patient is unable to give consent, a legal representative with a full command of the German language (understanding, reading, responding) and is able to give written informed consent can act on behalf of the patient
  • Caregivers:
  • - age = 18
  • - responsible for caring for the patient
  • - full command of the German language (understanding, reading, responding)
  • - ability to give written informed consent

排除标准

  • - lack of consent to follow protocol
  • - current drug abuse, alcohol abuse or psychiatric illness, which, in the opinion of the trial physician obtaining informed consent, renders the patient or caregiver unfit for participation
  • - any kind of dependency on the PCI or sponsor (including being employed there)
  • - legal incapacity (caregivers only)

研究者

发起方
niversität zu Köln

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