Clinical trial NCT04513561: 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
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Disease
Covid19
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 921
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients Inflammatory and Dysimmune Diseases Followed in the Context of IMMINeNT FHU IMMINeNT FHU (Rheumatology, Dermatology, Internal Medicine, Pneumology, Gastroenterology, Neurology).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The answer will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree".
timeFrame: At 2 months
Secondary outcomes:
measure: 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
timeFrame: At 2 months
measure: 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
timeFrame: At 2 months
measure: 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
timeFrame: At 2 months
measure: 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.
timeFrame: At 2 months
measure: 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.
timeFrame: At 2 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Frédéric DEZOTEUX, MD
role: PRINCIPAL_INVESTIGATOR
References: