NCT02374749

COMorbidities and EDucation in SPondyloArthritis Study

COmorbidities and EDucation in SpondyloArthritis Study (COMEDSPA) Evaluation of Standardized Follow-up in Axial Spondyloarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 503 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment". This study with its two parts should be able to demonstrate: * The importance of a systematic evaluation of comorbidities in Spondyloarthritis, * The utility of a nurse-led program of self-assessment and self-management of the disease

Detailed description

Patients with spondyloarthritis will be invited by their rheumatologists to participate at this study in 21 centers in France. 500 patients are planned to be included. After written informed consent will be obtained, the patients will be randomized in two arms: * comorbidities * self-assessment/self-management The patients will be seen again in the same center 12 months later in order to collect the outcome measures The two primary objectives of this trial are : * To evaluate the impact of a nurse led program of self-assessment of disease activity/severity and self-management on the level of satisfaction/coping * To evaluate the impact of a nurse led program of assessment of comorbidities on the management of such comorbidities The Secondary objectives are: * To evaluate the prevalence of comorbidities in SpA; * To evaluate the level of adherence to recommendations of prevention of comorbidities; * To evaluate the impact of the nurse led program of self-assessment / self-management on the amount of NSAID (Non-steroidal Anti-Inflammatory Drugs) intake and the level of disability (e.g. functional disability)

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
BEHAVIORAL	self-assessment/self-management	Nurse led-program of self-assessment/ self-management of spondyloarthritis
BEHAVIORAL	Comorbidities (detection/prevention)	Standardized assessment of comorbidities by nurses

Timeline

• Start date: 2015-03-23
• Primary completion: 2017-10-16
• Completion: 2017-10-16
• First posted: 2015-03-02
• Last updated: 2025-09-05

Locations

1 site across 1 country: France