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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03360864
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Education program
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 16, 2020
Anticipated Primary Completion Date :
Jan 16, 2022
Anticipated Study Completion Date :
Jan 16, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hôpitaux Universitaires de Strasbourg Strasbourg France 67000

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Christelle SORDET, MD, CHU de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT03360864
Other Study ID Numbers:
  • 6661
First Posted:
Dec 4, 2017
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020
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:
Spondylitis
Spondylarthritis

Study Results

No Results Posted as of Oct 27, 2020