Initial Standardized Global Review in Axial Spondyloarthritis

Official title

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

Overview

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.

Interventions

• Other Initial standardized global review
  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, spon

Primary outcome measures

• The change in patient knowledge of the disease. [Time frame: Visits Day 0 and Month 12]

Secondary outcome measures (12)

• Treatment [Time frame: Visits Day 0 and Month 12]
• The ability to cope with the disease [Time frame: Visits Day 0 and Month 12]
• Knowledge on b/tsDMARDs [Time frame: Visits Day 0 and Month 12]
• Adherence to axSpA treatments [Time frame: Visits Day 0 and Month 12]
• Disease activity [Time frame: Visits Day 0 and Month 12]
• Number of comorbidities [Time frame: Visit Month 12]
• Function change [Time frame: Visits Day 0 and Month 12]
• Quality of life change [Time frame: Visits Day 0 and Month 12]
• Work impairment [Time frame: Visit Month 12]
• Assessment of health services resources use [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 [Time frame: Visit Month 12]
• The sources of information accessed by patients [Time frame: Visits Day 0 and Month 12]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Patients who have already received a specific (or plan to receive in the coming 12 months) and dedicated program/global evaluation including education on the disease or treatments.
• Patients with any physical or mental condition that may affect understanding of the intervention or adherence to treatment (e.g. major depression or substance/alcohol use - might have impact on the outcomes of interest in the study).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 21 centers

• CHU Besançon - Hôpital Jean Minjoz — Besançon
• CHU Bordeaux - Hôpital Pellegrin — Bordeaux
• CHRU Brest - Hôpital de La Cavale Blanche — Brest
• CHU Caen — Caen
• CHU Clermont-Ferrand - Hôpital Gabriel-Montpied — Clermont-Ferrand
• AP-HP - Hôpital Henri Mondor — Créteil
• CHD Vendée — La Roche-sur-Yon
• AP-HP - Hôpital Bicêtre — Le Kremlin-Bicêtre
• … and 13 more centers

Identifiers

NCT: NCT07141017 · 2024-A02314-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗