Initial Standardized Global Review in Axial Spondyloarthritis (REVINSPA)

Association de Recherche Clinique en Rhumatologie

Status

Enrolling

Conditions

Axial Spondylarthritis (axSpA)

Treatments

Other: Initial standardized global review

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07141017

2024-A02314-43

Details and patient eligibility

About

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.

Enrollment

154 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).