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

Primary Purpose

Non-radiographic Spondyloarthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Education program
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-radiographic Spondyloarthritis focused on measuring Therapeutic education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Education Program

No therapeutic Education Program

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2017
Last Updated
October 23, 2020
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03360864
Brief Title
Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment
Acronym
ALSASP
Official Title
Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
January 16, 2022 (Anticipated)
Study Completion Date
January 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-radiographic Spondyloarthritis
Keywords
Therapeutic education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Education Program
Arm Type
Experimental
Arm 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.
Arm Title
No therapeutic Education Program
Arm Type
No Intervention
Arm Description
Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.
Intervention Type
Other
Intervention Name(s)
Education program
Intervention Description
Patient will participate to a education program.
Primary Outcome Measure Information:
Title
BIOSECURE patient self-questionnaire
Description
Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100.
Time Frame
Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle SORDET, MD
Phone
3 88 12 81 16
Ext
+33
Email
christelle.sordet@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle SORDET, MD
Organizational Affiliation
CHU de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle SORDET, MD
Phone
3 88 12 81 16
Ext
+33
Email
christelle.sordet@chru-strasbourg.fr

12. IPD Sharing Statement

Learn more about this trial

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

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