Inflammatory DiseaseCONFIMIDNCT04513561
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
An observational study of Inflammatory Disease and Covid19, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Disease, Covid19
- How many people
- 921 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2020to 27 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients Inflammatory and Dysimmune Diseases Followed in the Context of IMMINeNT FHU IMMINeNT FHU (Rheumatology, Dermatology, Internal Medicine, Pneumology, Gastroenterology, Neurology).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
- Conditions
- Inflammatory Disease, Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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? "
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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.
Measured: 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.
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.
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start21 Jul 2020
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric DEZOTEUX, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513561
- Sponsor's protocol ID
- 2020_51
- Other IDs
- 2020_A01596_33
- Acronym
- CONFIMID
- Status last verified
- Oct 2020
- First submitted
- 11 Aug 2020
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04513561
- Acronym / sponsor ID
- CONFIMID / 2020_51
- Conditions
- Inflammatory Disease, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients Inflammatory and Dysimmune Diseases Followed in the Context of IMMINeNT FHU IMMINeNT FHU (Rheumatology, Dermatology, Internal Medicine, Pneumology, Gastroenterology, Neurology).
Key inclusion criteria (8 listed)
- Chronic inflammatory bowel disease or IBD (Crohn's disease and ulcerative colitis),
- Inflammatory rheumatism (rheumatoid arthritis and spondylitis)
- Multiple Sclerosis
- Asthma
- Psoriasis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The answer will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree".
Time frame: 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? "
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric DEZOTEUX, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Disease and Covid19, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The answer will be considered positive if the patient answers "totally agree", or "agree", or "slightly agree", or "neither agree nor disagree". (time frame: At 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.