COMorbidities and EDucation in SPondyloArthritis Study

Axial Spondyloarthritis Clinical Trial

— COMEDSPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374749
• Other study ID #: P140401
• Status: Completed
• Phase: N/A
• First received: January 1, 2015
• Last updated: November 17, 2017
• Start date: March 23, 2015
• Est. completion date: October 16, 2017

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: October 16, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

Behavioral:
• self-assessment/self-management
Nurse led-program of self-assessment/ self-management of spondyloarthritis
• Comorbidities (detection/prevention)
Standardized assessment of comorbidities by nurses

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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