跳至主要内容
临床试验/NCT04510467
NCT04510467终止不适用

Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
296
试验地点
1
主要终点
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID

研究概览

简要总结

this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.

研究设计

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

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 case:
  • Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
  • With confirmed COVID-19 infection (at least one month prior to study inclusion)
  • Study information given to the patient
  • Patient affiliated to social security
  • Patient control:
  • Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
  • Not having had a confirmed COVID-19 infection
  • Study information given to the patient
  • Patient affiliated to social security

排除标准

  • Opposition to participation in the study by the patient and/or his legal representative
  • Adult patient not able to understand the implications and rules of the study
  • Protected adults under guardianship or curatorship

结局指标

主要结局

Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID

时间窗: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

次要结局

  • Severity of PTSD depending on whether or not autoimmune patients have experienced COVID(at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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