Clinical trial NCT02374749: COMorbidities and EDucation in SPondyloArthritis Study
Official title: COmorbidities and EDucation in SpondyloArthritis Study (COMEDSPA) Evaluation of Standardized Follow-up in Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis
Keywords: Axial Spondyloarthritis
Education
Co-morbidities
Nurse
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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)

Eligibility criteria: Inclusion Criteria:

1. Male or female over 18 and under 80 years
2. Axial Spondyloarthritis according to the ASAS criteria (Assessment of SpondyloArthritis international Society)
3. Disease duration of at least one year
4. Activity of SpA to be stable according to the treating rheumatologist for at least three months before the date of inclusion
5. Lack of elective surgery during the 6 months after inclusion
6. Able to understand and adhere to the study treatments
7. Development of a medical examination results given to the patient
8. Informed Consent signed and dated

Exclusion Criteria:

1. Pregnant women (any method of contraception will be accepted)
2. Patients who have had a change in the treatment of SpA during the 3 months prior to inclusion
3. History of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol
4. No affiliation to a social security regime

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Primary outcomes:
measure: Comorbidities
timeFrame: 1 year later
measure: self-assessment/self-management
timeFrame: 1 year later
Secondary outcomes:
measure: Frequency of comorbidities in Spondyloarthritis
timeFrame: 1 year later
measure: Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening
timeFrame: 1 year later
measure: Impact of self-assessment by the patient of his/her Spondyloarthritis activity (ASDAS-CRP (C Reactive Protein), BASDAI) on the activity and severity of the disease
timeFrame: 1 year later
measure: Patient compliance program self-management of Spondyloarthritis
timeFrame: 1 year later
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Maxime DOUGADOS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial. Semin Arthritis Rheum. 2020 Aug;50(4):701-708. doi: 10.1016/j.semarthrit.2020.05.012. Epub 2020 May 27.