Axial Spondylarthritis (axSpA)
Conditions
Keywords
Rheumatology, Initial standardized global review
Brief 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.
Interventions
OTHERInitial 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, 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.
Sponsors
RCTs
Association de Recherche Clinique en Rhumatologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study will be a cluster-randomized, controlled study with two parallel arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in patient knowledge of the disease. | Visits Day 0 and Month 12 | The primary endpoint will be the change in the SPAKE questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ability to cope with the disease | Visits Day 0 and Month 12 | 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 |
| Knowledge on b/tsDMARDs | Visits Day 0 and Month 12 | Knowledge on b/tsDMARDs, only in patients with b/tsDMARD, will be evaluated by the BioSECURE'21 questionnaire |
| Adherence to axSpA treatments | Visits Day 0 and Month 12 | Adherence to axSpA treatments in both groups will be evaluated by the CQR5 questionnaire |
| Disease activity | Visits Day 0 and Month 12 | Disease activity will be evaluated by the disease activity score (ASDAS) change in both groups |
| Number of comorbidities | Visit Month 12 | Number of comorbidities managed according to recommendations in both groups |
| Treatment | Visits Day 0 and Month 12 | Treatment in both groups will be evaluated NSAID intake and % of patients receiving csDMARD/bDMARD/tsDMARD |
| Quality of life change | Visits Day 0 and Month 12 | Quality of life change in both groups will be evaluated by the ASAS-HI questionnaire |
| Work impairment | Visit Month 12 | Work impairment will be evaluated by the WPAI questionnaire |
| Assessment of health services resources use | Visit Month 12 | Assessment of health services resources use will be evaluated by self-questionnaire |
| 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 | 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 will be evaluated by the Likert scale |
| The sources of information accessed by patients | Visits Day 0 and Month 12 | The sources of information accessed by patients in both groups be evaluated with the percentage of patients who participated in a therapeutic education programme |
| Function change | Visits Day 0 and Month 12 | Function change in both groups between will be evaluated by the BASFI questionnaire |
Countries
France
Contacts
Primary ContactAnna Molto
Outcome results
None listed