Evaluating the Impact of an Initial Standardized Global Review in Patients With Early Axial Spondyloarthritis: a Multicenter Randomized Cluster-controlled Study

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will be a pragmatic, cluster-randomized, controlled study with two parallel arms ( 'intervention' and 'usual care' (UC) arms) of one year duration. The study will be open-label, but centers randomized in the UC arm will not be aware of the intervention performed in the 'intervention' centers. The primary objective of this study will be to determine whether participation in a standardized global review (that includes assessment of disease domains and education ) as soon as possible after diagnosis of axial spondyloarthritis has a beneficial impact on patient knowledge of the disease at 12 months. The primary endpoint will be the change in the SPAKE (SPondyloArthritis Knowledge Questionnaire) questionnaire between M0 and M12.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults (but age \<80years) with a diagnosis of axial spondyloarthritis determined by the treating rheumatologist within the 12 months preceding the baseline visit, who have completed the informed consent and have the ability to complete all study activities.

Locations
Other Locations
France
CHU Besançon - Hôpital Jean Minjoz
NOT_YET_RECRUITING
Besançon
CHU Bordeaux - Hôpital Pellegrin
NOT_YET_RECRUITING
Bordeaux
CHRU Brest - Hôpital de La Cavale Blanche
NOT_YET_RECRUITING
Brest
CHU Caen
RECRUITING
Caen
CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
ACTIVE_NOT_RECRUITING
Clermont-ferrand
AP-HP - Hôpital Henri Mondor
RECRUITING
Créteil
CHD Vendée
ACTIVE_NOT_RECRUITING
La Roche-sur-yon
AP-HP - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
CH Le Mans
ACTIVE_NOT_RECRUITING
Le Mans
GHICL - Hôpital Saint Philibert
NOT_YET_RECRUITING
Lomme
AP-HM - Hôpital St Marguerite
ACTIVE_NOT_RECRUITING
Marseille
AP-HP - Hôpital Cochin
RECRUITING
Paris
AP-HP - Hôpital La Pitié Salpétrière
RECRUITING
Paris
AP-HP - Hôpital Lariboisière
NOT_YET_RECRUITING
Paris
AP-HP - Hôpital Saint Antoine
RECRUITING
Paris
HCL - Hôpital Lyon Sud
RECRUITING
Pierre-bénite
CHU Rouen - Hôpital Charles-Nicolle
RECRUITING
Rouen
CHU Saint Etienne - Hôpital Nord
NOT_YET_RECRUITING
Saint-priest-en-jarez
CHU Strasbourg - Hôpital de Hautepierre
RECRUITING
Strasbourg
Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet
RECRUITING
Toulouse
CHU Tours - Hôpital Trousseau
RECRUITING
Tours
Contact Information
Primary
Anna Molto
anna.molto@aphp.fr
+33158412576
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2027-05
Participants
Target number of participants: 154
Treatments
Experimental: Intervention arm
No_intervention: Usual care arm
Sponsors
Leads: Association de Recherche Clinique en Rhumatologie
Collaborators: RCTs

This content was sourced from clinicaltrials.gov

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