COMorbidities and EDucation in SPondyloArthritis Study (COMEDSPA)

August 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Axial Spondyloarthritis

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

503

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 75014
    - Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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
-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: comorbidities 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) Standardized assessment of comorbidities by nurses
Active Comparator: self-assessment 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 Nurse led-program of self-assessment/ self-management of spondyloarthritis

Participant Group / Arm

Intervention / Treatment

Active Comparator: comorbidities

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)

Standardized assessment of comorbidities by nurses

Active Comparator: self-assessment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities Time Frame: 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.	1 year later
self-assessment/self-management Time Frame: 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.	1 year later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of comorbidities in Spondyloarthritis Time Frame: 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.	1 year later
Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening Time Frame: 1 year later	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 Time Frame: 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	1 year later
Patient compliance program self-management of Spondyloarthritis Time Frame: 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).	1 year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

Principal Investigator: Maxime Dougados, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2015

Primary Completion (Actual)

October 16, 2017

Study Completion (Actual)

October 16, 2017

Study Registration Dates

First Submitted

January 1, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimated)

March 2, 2015

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

P140401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

COMorbidities and EDucation in SPondyloArthritis Study (COMEDSPA)