COMorbidities and EDucation in SPondyloArthritis Study (COMEDSPA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Axial Spondyloarthritis

Treatments: Behavioral: Comorbidities (detection/prevention); Behavioral: self-assessment/self-management

Study type: Interventional

Funder types: Other

Identifiers

NCT02374749

P140401

Details and patient eligibility

About

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

Full 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)

Enrollment: 503 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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503 participants in 2 patient groups

comorbidities

Active Comparator group

Description:

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.

Treatment:

Behavioral: Comorbidities (detection/prevention)

self-assessment

Active Comparator group

Description:

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.

Treatment:

Behavioral: self-assessment/self-management