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Clinical Trials/NCT03360864
NCT03360864
Unknown
Not Applicable

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

University Hospital, Strasbourg, France1 site in 1 country110 target enrollmentJanuary 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-radiographic Spondyloarthritis
Sponsor
University Hospital, Strasbourg, France
Enrollment
110
Locations
1
Primary Endpoint
BIOSECURE patient self-questionnaire
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2020
End Date
January 16, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

BIOSECURE patient self-questionnaire

Time Frame: 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.

Study Sites (1)

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