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临床试验/NCT04513561
NCT04513561已完成不适用

Evaluation of the Impact of Lock Down and End of Lock Down on the Management of Patients With Inflammatory and Dysimmune Diseases Followed in the Context of IMMINeNT FHU (Rheumatology, Dermatology, Internal Medicine, Pneumology, Gastroenterology, Neurology).

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 921 人开始时间: 2020年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
921
试验地点
1
主要终点
The answer will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree".

研究概览

简要总结

This questionnaire is distributed via a mailing list (e-mail) of patients treated within the framework of the FHU for pathologies including chronic inflammatory bowel diseases or IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (such as rheumatoid arthritis and ankylosing spondylitis), but also asthma, psoriasis, atopic dermatitis as well as systemic autoimmune (such as scleroderma, lupus, angioedema) and neurological (multiple sclerosis) diseases.

A two-step analysis will be conducted: impact of lock down(March 17, 2020 - May 11, 2020) and a 2-month assessment of end of lock down (from May 11, 2020) on issues addressing: overall impact, impact on the disease, treatment and follow-up, and access to information related to the epidemic during these periods.

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

入选标准

  • patient followed for :
  • Chronic inflammatory bowel disease or IBD (Crohn's disease and ulcerative colitis),
  • Inflammatory rheumatism (rheumatoid arthritis and spondylitis)
  • Multiple Sclerosis
  • Psoriasis
  • Atopic Dermatitis
  • Systemic autoimmune diseases (scleroderma and lupus)

排除标准

  • Minor patient
  • Patient cannot read or write
  • Patient without computer equipment
  • Patient with no internet access
  • Patient not having filled in his e-mail in his file
  • Patient does not wish to be contacted by email

结局指标

主要结局

The answer will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree".

时间窗: At 2 months

The answer to question 13 of the lock down questionnaire: "Do you feel that you have been less well followed by your medical specialist compared to the pre-lock down period? "

次要结局

  • Proportion of patients (in percentage and numbers) whose response is considered positive if the patient answered "Slightly agree", "Agree" or "Totally agree" to question 9 of the lock down questionnaire(At 2 months)
  • Proportion of patients (in percentage and numbers) whose response is considered positive if the patient answered "yes" to question 34 of the lock down questionnaire(At 2 months)
  • Proportion of patients (in percentage and numbers) whose response is considered positive if the patient answered "Slightly agree" or "Agree" or "Strongly agree" to question 38 of the lock down questionnaire(At 2 months)
  • Proportion of patients (in percentages and numbers) whose response will be considered positive to questions 13 and 14 of the lock down questionnaire and comparison between the different specialities filled in in question 3.(At 2 months)
  • Proportion of patients (in percent and numbers) whose response will be considered positive to questions 9, 13, 14, 38 or "Yes" to question 34 of the end of lock down and lock down Evaluation Questionnaire.(At 2 months)

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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