Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy (PRECI)

February 28, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

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
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

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

Description

Inclusion Criteria:

  • Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
  • Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion
  • Major patient
  • Patient having signed an informed consent

Exclusion Criteria:

  • Minor patient
  • Patient with cognitive impairment diagnosed by a physician
  • Patient under tutorship or curatorship
  • Patient deaf or hard of hearing
  • Patient not fluent in the French language (at the decision of the investigator)

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nursing consultation
Device: nursing consultation
nursing consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of BIOSECURE score between baseline and after nurse consultation
Time Frame: one day
Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100.
one day

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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 4, 2019

Primary Completion (Actual)

November 4, 2021

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2019_843_0045

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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