Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Spondyloarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: None (Open Label)Masking Description: no maskingPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 statis...
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) : 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. 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.
Tracking Information
- NCT #
- NCT03838939
- Collaborators
- French Society of Rheumatology
- Investigators
- Principal Investigator: Françoise FAYET University Hospital, Clermont-Ferrand
Get Well Soon