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| Name | Class |
|---|---|
| RCTs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental |
| |
| Usual care arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial standardized global review | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in patient knowledge of the disease. | The primary endpoint will be the change in the SPAKE questionnaire | Visits Day 0 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment | Treatment in both groups will be evaluated NSAID intake and % of patients receiving csDMARD/bDMARD/tsDMARD | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Molto | Contact | +33158412576 | anna.molto@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon - Hôpital Jean Minjoz | Not yet recruiting | Besançon | France |
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The study will be a cluster-randomized, controlled study with two parallel arms
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| 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 | Visits Day 0 and Month 12 |
| Adherence to axSpA treatments | Adherence to axSpA treatments in both groups will be evaluated by the CQR5 questionnaire | Visits Day 0 and Month 12 |
| Disease activity | Disease activity will be evaluated by the disease activity score (ASDAS) change in both groups | Visits Day 0 and Month 12 |
| Number of comorbidities | Number of comorbidities managed according to recommendations in both groups | Visit Month 12 |
| Function change | Function change in both groups between will be evaluated by the BASFI questionnaire | 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 | Visits Day 0 and Month 12 |
| Work impairment | Work impairment will be evaluated by the WPAI questionnaire | Visit Month 12 |
| Assessment of health services resources use | Assessment of health services resources use will be evaluated by self-questionnaire | 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 | 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 | Visits Day 0 and Month 12 |
| CHU Bordeaux - Hôpital Pellegrin | Not yet recruiting | Bordeaux | France |
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| CHRU Brest - Hôpital de La Cavale Blanche | Not yet recruiting | Brest | France |
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| CHU Caen | Recruiting | Caen | France |
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| CHU Clermont-Ferrand - Hôpital Gabriel-Montpied | Active, not recruiting | Clermont-Ferrand | France |
| AP-HP - Hôpital Henri Mondor | Recruiting | Créteil | France |
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| CHD Vendée | Active, not recruiting | La Roche-sur-Yon | France |
| AP-HP - Hôpital Bicêtre | Recruiting | Le Kremlin-Bicêtre | France |
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| CH Le Mans | Active, not recruiting | Le Mans | France |
| GHICL - Hôpital Saint Philibert | Not yet recruiting | Lomme | France |
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| AP-HM - Hôpital St Marguerite | Active, not recruiting | Marseille | France |
| AP-HP - Hôpital Cochin | Recruiting | Paris | France |
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| AP-HP - Hôpital La Pitié Salpétrière | Recruiting | Paris | France |
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| AP-HP - Hôpital Lariboisière | Not yet recruiting | Paris | France |
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| AP-HP - Hôpital Saint Antoine | Recruiting | Paris | France |
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| HCL - Hôpital Lyon Sud | Recruiting | Pierre-Bénite | France |
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| CHU Rouen - Hôpital Charles-Nicolle | Recruiting | Rouen | France |
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| CHU Saint Etienne - Hôpital Nord | Not yet recruiting | Saint-Priest-en-Jarez | France |
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| CHU Strasbourg - Hôpital de Hautepierre | Recruiting | Strasbourg | France |
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| Hopitaux de Toulouse (CHU) - Hôpital Pierre Paul Riquet | Recruiting | Toulouse | France |
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| CHU Tours - Hôpital Trousseau | Recruiting | Tours | France |
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