Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism (RICOVID19)

January 24, 2021 updated by: University Hospital, Limoges

Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism According to a Management Strategy in the Rheumatology Department of Limoges University Hospital

Patients with chronic inflammatory rheumatism (RIC) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a "treat to target" strategy with rapid adaptation of treatments to the activity of their disease. according to French recommendations.

They are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (JAK inhibitors) They can also be treated transiently or over the long term with corticosteroids. These treatments expose them to greater infectious risks, especially with regard to COVID19.

The objective is on the one hand to assess the impact of the Covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France
        • Département de Rhumatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges

Description

Inclusion Criteria:

All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges.

Exclusion Criteria:

Patients who object to the use of their data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed patients
Those who had the management strategy implemented by the service during confinement
Other: questionnaires
Questionnaire completion
Unexposed patients
Those who could not benefit from this strategy
Other: questionnaires
Questionnaire completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-traumatic stress
Time Frame: Day 1
Presence or absence of post-traumatic stress disorder due to the COVID19 pandemic assessed by the Post-traumatic stress disorder Check-list version DSM-5 (PCL-5)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI20_0062 /RICOVID19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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