COMorbidities and EDucation in SPondyloArthritis Study

Not Applicable

Completed

• Conditions: Axial Spondyloarthritis
• Interventions: Behavioral: Comorbidities (detection/prevention); Behavioral: self-assessment/self-management

• Registration Number: NCT02374749
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)

Study Timeline

• Study First Submitted: 2015-01-01
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Study Start: 2015-03-23
• Primary Completion: 2017-10-16
• Study Completion: 2017-10-16
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
comorbidities	Comorbidities (detection/prevention)	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.
self-assessment	self-assessment/self-management	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.

Primary Outcome Measures

Name	Time	Method
self-assessment/self-management	1 year later	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.
Comorbidities	1 year later	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening	1 year later	The percentage of patients adhering to these recommendations will be assessed.
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	1 year later	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
Frequency of comorbidities in Spondyloarthritis	1 year later	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.
Patient compliance program self-management of Spondyloarthritis	1 year later	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).

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France