COMorbidities and EDucation in SPondyloArthritis Study

Assistance Publique - Hôpitaux de Paris503 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

503

Conditions

Axial Spondyloarthritis

Interventions

self-assessment/self-managementBEHAVIORAL

Nurse led-program of self-assessment/ self-management of spondyloarthritis

Comorbidities (detection/prevention)BEHAVIORAL

Standardized assessment of comorbidities by nurses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Hôpital Cochin

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 year later

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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