NCT04806867

Brief Summary

The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

Trial Health

87
On Track

Trial Health Score

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

Enrollment
918

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

May 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

December 9, 2020

Last Update Submit

March 29, 2021

Conditions

Keywords

Chronic Inflammatory Rheumatism - COVID-19

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.

    Number of request for advice from the referring Rheumatologist by the student and/or the patient

    2 months

Secondary Outcomes (8)

  • Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied

    2 months

  • COVID-19 infection evaluation in the monitored patient population

    2 months

  • Proportion of patients informed about COVID-19

    2 months

  • Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied

    2 months

  • Evaluate the association between pain increase perceived by patients and the factors studied

    2 months

  • +3 more secondary outcomes

Interventions

All patients with Chronic Inflammatory Rheumatism who were contacted by telephone as part of the innovative organizational strategy and who did not object to the use of their data.

Eligibility Criteria

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

Patients with chronic inflammatory rheumatism

You may qualify if:

  • Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.

You may not qualify if:

  • Patients objecting to the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rhumatologie, CHu de Limoges

Limoges, 87000, France

Location

MeSH Terms

Conditions

COVID-19Rheumatic FeverArthritis, RheumatoidSpondylarthritisArthritis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Pascale PV Vergne-Salle, MD-PhD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 9, 2020

First Posted

March 19, 2021

Study Start

May 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 31, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations