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 and COVID-19

Covid19 Clinical Trial

— CONFIMID  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513561
• Other study ID #: 2020_51
• Secondary ID: 2020_A01596_33
• Status: Completed
• Start date: July 21, 2020
• Est. completion date: August 27, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 921
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

patient followed for :

• Chronic inflammatory bowel disease or IBD (Crohn's disease and ulcerative colitis),

• Inflammatory rheumatism (rheumatoid arthritis and spondylitis)

• Multiple Sclerosis

• Asthma

• Psoriasis

• Atopic Dermatitis

• Systemic autoimmune diseases (scleroderma and lupus)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19
• Inflammatory Disease

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The answer will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree".	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? "	At 2 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	Proportion of patients (in percentages and numbers) whose response will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree" to questions 13 and 14 of the lock down questionnaire and comparison between the different specialities filled in in question 3.	At 2 months
Secondary	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.	Proportion of patients (in percent and numbers) whose response will be considered positive if the patient answers "Slightly agree", "Agree" or "Strongly agree" 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