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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
154
The intervention under study will be the initial standardized global review, which will be performed as soon as axial spondyloarthritis is diagnosed (less than 12 months from diagnosis is mandatory) and only at the baseline visit. This review includes both the assessment of different domains of the disease, but also the education and information on such different domains of the disease and its management The domains assessed during the intervention will be: diagnosis of spondyloarthritis, spondyloarthritis phenotype, disease activity, disease severity and function, treatment adherence and comorbidities. At the end of the intervention, a detailed medical report on this initial standardized global review will be produced and sent to the patient, their rheumatologist, their general practitioner, and their dispensing pharmacist.
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
NOT_YET_RECRUITINGCHU Bordeaux - Hôpital Pellegrin
Bordeaux, France
NOT_YET_RECRUITINGCHRU Brest - Hôpital de La Cavale Blanche
Brest, France
NOT_YET_RECRUITINGCHU Caen
Caen, France
RECRUITINGCHU Clermont-Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, France
ACTIVE_NOT_RECRUITINGAP-HP - Hôpital Henri Mondor
Créteil, France
RECRUITINGCHD Vendée
La Roche-sur-Yon, France
ACTIVE_NOT_RECRUITINGAP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France
RECRUITINGCH Le Mans
Le Mans, France
ACTIVE_NOT_RECRUITINGGHICL - Hôpital Saint Philibert
Lomme, France
NOT_YET_RECRUITING...and 11 more locations
The change in patient knowledge of the disease.
The primary endpoint will be the change in the SPAKE questionnaire
Time frame: Visits Day 0 and Month 12
Treatment
Treatment in both groups will be evaluated NSAID intake and % of patients receiving csDMARD/bDMARD/tsDMARD
Time frame: Visits Day 0 and Month 12
The ability to cope with the disease
The ability to cope with the disease will be evaluated by disease coping change between Day 0 and Month 12 in both groups using the Coping Scale from the RAID questionnaire
Time frame: Visits Day 0 and Month 12
Knowledge on b/tsDMARDs
Knowledge on b/tsDMARDs, only in patients with b/tsDMARD, will be evaluated by the BioSECURE'21 questionnaire
Time frame: Visits Day 0 and Month 12
Adherence to axSpA treatments
Adherence to axSpA treatments in both groups will be evaluated by the CQR5 questionnaire
Time frame: Visits Day 0 and Month 12
Disease activity
Disease activity will be evaluated by the disease activity score (ASDAS) change in both groups
Time frame: Visits Day 0 and Month 12
Number of comorbidities
Number of comorbidities managed according to recommendations in both groups
Time frame: Visit Month 12
Function change
Function change in both groups between will be evaluated by the BASFI questionnaire
Time frame: Visits Day 0 and Month 12
Quality of life change
Quality of life change in both groups will be evaluated by the ASAS-HI questionnaire
Time frame: Visits Day 0 and Month 12
Work impairment
Work impairment will be evaluated by the WPAI questionnaire
Time frame: Visit Month 12
Assessment of health services resources use
Assessment of health services resources use will be evaluated by self-questionnaire
Time frame: Visit Month 12
The patient's perception of the benefits of this type of initial global standardized review on patient's follow-up and the treating rheumatologist's perception of the benefits of this type of initial global standardized review on patient follow-up
The patient's perception of the benefits of this type of initial global standardized review on patient's follow-up and the treating rheumatologist's perception of the benefits of this type of initial global standardized review on patient follow-up will be evaluated by the Likert scale
Time frame: Visit Month 12
The sources of information accessed by patients
The sources of information accessed by patients in both groups be evaluated with the percentage of patients who participated in a therapeutic education programme
Time frame: Visits Day 0 and Month 12
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