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
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