COMorbidities and EDucation in SPondyloArthritis Study

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Behavioral: self-assessment/self-management
* Behavioral: Comorbidities (detection/prevention)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 and under 80 years Axial Spondyloarthritis according to the ASAS criteria (Assessment of SpondyloArthritis international Society) Disease duration of at least one year Activity of SpA to be stable according to the treating rheumatologist for at least three months before the date of inclusion Lack of elective surgery during the 6 months after inclusion Able to understand and adhere to the study treatments Development of a medical examination results given to the patient Informed Consent signed and dated Exclusion Criteria: Pregnant women (any method of contraception will be accepted) Patients who have had a change in the treatment of SpA during the 3 months prior to inclusion History of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol No affiliation to a social security regime -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: comorbidities<br>Evaluation of the prevalence and the presence of the risks factors of the four most frequently observed comorbidities in spondyloarthritis (cardiovascular diseases, cancers, infections osteoporosis and gastro-intestinal) as it is recommended by the French Society of Rheumatology. | Behavioral: Comorbidities (detection/prevention)<br>* Standardized assessment of comorbidities by nurses<br>|
| Active Comparator: self-assessment<br>During the initial visit, the clinical research nurse exempt a learning program of assessment of disease activity/severity : for assessing the activity in SpA; for the calculation of BASDAI and the ASDAS-CRP for the transfer technique and for the calculation of the disease activity on a monthly basis during the next 12 months. for the risk of tobacco exposure for the benefit of an NSAID intake in case of painful episode of the disease for the benefit of home exercises for the spine and indication of a treatment under the supervision of a physiotherapist in case of severe disease for learning the patient to calculate his BASDAI and ASDAS-CRP Then, the patient will return home with his calculator and his notebook. Each month, the patient will be asked to perform the BASDAI and ASDAS-CRP calculations and to report the data on the notebook. 12 months later, the patient comes for a visit in the current practice to assess both such program and comorbidities. | Behavioral: self-assessment/self-management<br>* Nurse led-program of self-assessment/ self-management of spondyloarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities | Changes after 12 months in the comorbidity composite score. Such composite score has been established prior the study and is taking into account the optimal management of patients (e.g. Normal blood pressure, no smoking,....) . Such score will be calculated at baseline and at the one year visit in the two groups. | 1 year later | 
| self-assessment/self-management | The level of coping after 12 months based on the question#8 ( 0-10 NRS) of the RAID score. Such outcome will be evaluated at both the baseline and the one year visits in both groups. | 1 year later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of comorbidities in Spondyloarthritis | This analysis will be purely descriptive and will include the percentage of patients with: History of cardiovascular diseases Hypertension Diabetes Hyperlipidemia History of skin cancer, colon, uterus, breast, prostate Percentage of patients at high risk of cancers when these risks are known (eg, family history of breast cancer, colon) History of tuberculosis, HIV, or hospitalization for severe infections. | 1 year later | 
| Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening | The percentage of patients adhering to these recommendations will be assessed. | 1 year later | 
| 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 | The final value of BASDAI and ASDAS-CRP will be compared in the two groups of patients by adjusting the analysis of the initial value. The final visit BASFI value will be compared in the two groups of patients by adjusting the analysis of the initial value | 1 year later | 
| Patient compliance program self-management of Spondyloarthritis | Compliance will be assessed by the percentage of the collections of the disease activity (BASDAI, ASDAS-CRP) actually made by the patient with regard the theoretical number one (e.g. monthly). | 1 year later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axial Spondyloarthritis, Education, Co-morbidities, Nurse