Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism — ERIBIO  

Rheumatoid Arthritis Clinical Trial

Official title: Impact of Association of Individual and Group Therapeutic Education Sessions on the Acquisition of Safety Skills by Patients With Chronic Inflammatory Rheumatism (CIR) Treated With Subcutaneous Biotherapy, Compared to Individual Therapeutic Education Sessions Alone

Status Completed

Clinical Trial Summary

The hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with CIR treated by subcutaneous biotherapies.

Clinical Trial Description

Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at M0) :

1. Experimental group (individual and group therapeutic education )

• M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".

• M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops :

"Subcutaneous injection education" and "biotherapy management".

• M6 (individual presential or by phone) Assessment of security skills and questionnaires.

• M12 (individual presential or by phone) Assessment of security skills and questionnaires.

2. Control group (individual therapeutic education alone ) :

• M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".

• M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".

• M6 (individual présential or by phone) Assessment of security skills and questionnaires.

• M12 (individual présential or by phone) Assessment of security skills and questionnaires. Group session proposed. ;

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

• NCT number: NCT03838939
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Completion date: December 10, 2021