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CONFIMID: 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

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT04513561
Collaborator
(none)
921
Enrollment
1
Location
1.2
Actual Duration (Months)
757.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    921 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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).
    Actual Study Start Date :
    Jul 21, 2020
    Actual Primary Completion Date :
    Aug 27, 2020
    Actual Study Completion Date :
    Aug 27, 2020

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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 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.

    5. 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]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hop Claude Huriez Chu Lille Lille France 59037

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Frédéric DEZOTEUX, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04513561
    Other Study ID Numbers:
    • 2020_51
    • 2020_A01596_33
    First Posted:
    Aug 14, 2020
    Last Update Posted:
    Mar 15, 2021
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 15, 2021