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

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ClinicalTrials.gov Identifier: NCT03360864
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non-radiographic Spondyloarthritis Other: Education program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : January 16, 2022
Estimated Study Completion Date : January 16, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Therapeutic 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.

 Other: Education program
Patient will participate to a education program.
No Intervention: No therapeutic Education Program
Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360864


Contacts
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Contact: Christelle SORDET, MD 3 88 12 81 16 ext +33 christelle.sordet@chru-strasbourg.fr

Locations
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France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Christelle SORDET, MD    3 88 12 81 16 ext +33    christelle.sordet@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Christelle SORDET, MD CHU de Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03360864    
Other Study ID Numbers: 6661
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Therapeutic education
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
 Musculoskeletal Diseases
Arthritis
Joint Diseases