Non-radiographic Spondyloarthritis
Conditions
Keywords
Therapeutic education
Brief summary
To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation. The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP. Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.
Interventions
OTHEREducation program
Patient will participate to a education program.
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-radiological spondyloarthritis diagnosis (ASAS criteria) * Anti-TNFalpha biological treatment initiation required * Adult patient (age\>18years) * Capacity to understand self-questionnaires and address questions * Patient accepting to attend a therapeutic education program (TEP)
Exclusion criteria
* Previous Anti-TNFalpha biological treatment * Previous attendance to a TEP concerning biological or spondyloarthritis * Contraindication to Anti-TNFalpha treatment * Associated and unbalanced diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIOSECURE patient self-questionnaire | Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation | Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100. |
Countries
France
Contacts
Primary ContactChristelle SORDET, MD
Outcome results
None listed