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 : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : January 9, 2018
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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)|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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.
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
|Contact: Christelle SORDET, MD||+33 88 12 81 firstname.lastname@example.org|
|Principal Investigator:||Christelle SORDET, MD||CHU de Strasbourg|