NCT04723407

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 22, 2021

Last Update Submit

January 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • post-traumatic stress

    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

Study Arms (2)

Exposed patients

Those who had the management strategy implemented by the service during confinement

Other: questionnaires

Unexposed patients

Those who could not benefit from this strategy

Other: questionnaires

Interventions

Questionnaire completion

Exposed patientsUnexposed patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients who object to the use of their data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Rhumatologie

Limoges, France

Location

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Corinne TRAPY

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 25, 2021

Study Start

February 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations