NCT03838939

Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis
• Spondyloarthritis

Interventions

Type	Name	Description
OTHER	Therapeutic education	Individual and group therapeutic education sessions will consist of : * acquisition by patient of self-care skills such as performing subcutaneous injection, * acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...

Timeline

• Start date: 2019-01-21
• Primary completion: 2021-12-10
• Completion: 2021-12-10
• First posted: 2019-02-12
• Last updated: 2021-12-22

Locations

1 site across 1 country: France