NCT04354519已完成不适用
The UK MS Regsiter COVID-19 Substudy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.
详细描述
Study objectives
- To identify the incidence of upper respiratory tract symptoms: fever, cough and breathing difficulties, other symptoms suggestive of COVID-19 infection, respiratory tract infections suggestive of COVID-19, and COVID-19 confirmed by laboratory testing among the UK MS population
- To establish if some DMDs increase the risk of COVID-19 infection
- To determine the incidence and effectiveness of self-isolation in the MS population. To examine the impact self-isolation has on mood, fatigue, and other routinely collected patient reported outcome measures from the MS Register.
- To determine the clinical outcome of respiratory tract infections, including confirmed and suspected cases of COVID-19, in terms of symptoms, time to recovery, hospital admission, requirement for ventilation, and death.
- To determine the longer-term impact of COVID-19 on MS, using routinely collected MS outcomes in the MS register, including impact on disability, relapses and changes in DMDs as assessed at 3 monthly intervals.
- To determine where people are obtaining their health information during the COVID-19 outbreak.
- To establish changes in DMDs prior to and as a result of symptoms related and unrelated to COVID-19
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
- 否
入选标准
- •>18 and confirmed diagnosis of MS, enrolled on UK MS Register
排除标准
- •None of the above
结局指标
主要结局
Mortality
时间窗: 1 Year from study commencement
Death data from routinely reported government level data (HES/PEDW)
Incidence of COVID-19 Infections within an MS Cohort in the UK
时间窗: Through study completion, an average of 1 year
Targeted questionnaire dependent on COVID Status
Hospitalisations in MS Patients with COVID-19
时间窗: 1 Year (regular outputs)
Monitor admission rates in linked population
次要结局
- Patient Reported Expanded Disability Status Score(1 year (at least 6 monthly))
- Hospital Anxiety and Depression Scale(1 year (at least 6 monthly))
- Multiple Sclerosis Walking Scale 12 V2(1 year (at least 6 monthly))
- Fatigue Severity Scale(1 year (at least 6 monthly))
- EuroQol 5D (3l)(1 year (at least 6 monthly))
- Multiple Sclerosis Impact Scale 29 V2(1 year (at least 6 monthly))
研究者
研究点 (2)
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