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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Non-radiographic Spondyloarthritis

Treatments: Other: Education program

Study type: Interventional

Funder types: Other

Identifiers

NCT03360864

6661

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Therapeutic Education Program

Experimental group

Description:

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.

Treatment:

Other: Education program

No therapeutic Education Program

No Intervention group

Description:

Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.