Virtual Management of Rheumatoid Arthritis (ePRAT)

December 30, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Rheumatoid Arthritis at the Time of Telemedicine

The purpose of this study is to optimize the care of patients with RA seen in virtual consultation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be organized in two consecutive steps:

  1. A first descriptive step that will consist of a retrospective analysis of virtual consultation records of patients with RA during the pandemic and lockdown period in order to analyze on which criteria the patients were assessed and followed during this period.
  2. The second step will consist in evaluating the interest of the systematic use in virtual consultation of a patient reported outcome (PRO), the RAID (Rheumatoid Arthritis Impact of Disease) questionnaire; and analyze how its results influence the rheumatologist decision-making.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75014
        • Recruiting
        • Rheumatology Department, Cochin Hospital
        • Contact:
        • Principal Investigator:
          • Jérôme Avouac
        • Sub-Investigator:
          • Yannick ALLANORE

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rheumatoid arthritis followed in a tertiary center (University Hospital Cochin)

Description

Inclusion Criteria:

  • Patients with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria
  • Follow-up in the rheumatology department of Cochin Hospital
  • Affiliated with a social security scheme
  • Non-opposition to participating in the study
  • Patients with a valid email address (registration to the virtual consultation system)

Exclusion Criteria:

  • Opposition to participate to this research
  • Inability to understand or speak French
  • Patient under tutor or curator ship
  • patients under medical state help

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with rheumatoid arthritis
Patients seen in virtual consultation
Other: Rheumatoid Arthritis Impact of Disease questionnaire
Rheumatoid Arthritis Impact of Disease questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of face to face consultation, hospitalization and therapeutic modifications
Time Frame: Inclusion
The primary outcome will be the rate of face to face consultation, hospitalization and therapeutic modifications decided by the rheumatologist during the virtual consultation
Inclusion

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jérôme Avouac, MD, PhD, Assistance Publique - Hôpitaux de Paris

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 (Actual)

November 30, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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