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

NCT03360864 | Unknown

• 1 other identifier: 6661
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-radiographic Spondyloarthritis

Keywords

Therapeutic education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Therapeutic Education Program

EXPERIMENTAL

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

No therapeutic Education Program

NO INTERVENTION

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

Interventions

Education program OTHER

Patient will participate to a education program.

Therapeutic Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Previous Anti-TNFalpha biological treatment
• Previous attendance to a TEP concerning biological or spondyloarthritis
• Contraindication to Anti-TNFalpha treatment
• Associated and unbalanced diseases

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Christelle SORDET, MD

  CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle SORDET, MD

CONTACT

3 88 12 81 16; christelle.sordet@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: January 16, 2020
• Primary Completion: January 16, 2022
• Study Completion: January 16, 2023
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

FR (1)