Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)

Conditions
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Non-radiographic Spondyloarthritis

Intervention / Treatment
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* Other: Education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Education Program<br>Patient randomized in this arm will attend a 1 day long validated Therapeutic Education Program. This program will take place within 6 months after biologic treatment initiation. | Other: Education program<br>* Patient will participate to a education program.<br>|
| No Intervention: No therapeutic Education Program<br>Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIOSECURE patient self-questionnaire | Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100. | Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic education