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

Not Applicable

• Conditions: Non-radiographic Spondyloarthritis
• Interventions: Other: Education program

• Registration Number: NCT03360864
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-04
• Study Start: 2020-01-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27
• Primary Completion: 2022-01-16
• Study Completion: 2023-01-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Education Program	Education program	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France