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

Not Applicable

Active, not recruiting

• Conditions: Rheumatology; Rheumatoid Arthritis; Biotherapies
• Interventions: Device: nursing consultation

• Registration Number: NCT05762185
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Primary Completion: 2021-11-04
• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nursing consultation	nursing consultation	-

Primary Outcome Measures

Name	Time	Method
Variation of BIOSECURE score between baseline and after nurse consultation	one day	Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100.

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France