NCT04513561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
921

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

March 15, 2021

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

August 11, 2020

Last Update Submit

March 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Frédéric DEZOTEUX, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 14, 2020

Study Start

July 21, 2020

Primary Completion

August 27, 2020

Study Completion

August 27, 2020

Last Updated

March 15, 2021

Record last verified: 2020-10

Locations