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

Non-radiographic Spondyloarthritis Clinical Trial

— ALSASP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360864
• Other study ID #: 6661
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: January 16, 2023

Study information

• Verified date: October 2020
• Source: University Hospital, Strasbourg, France
• Contact: Christelle SORDET, MD
• Phone: 3 88 12 81 16
• Email: christelle.sordet[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-radiographic Spondyloarthritis
• Spondylarthritis

Intervention

Other:
• Education program
Patient will participate to a education program.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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