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Completed

NCT Number: NCT02374749

COMorbidities and EDucation in SPondyloArthritis Study

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

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin

Paris, 75014, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

self-assessment/self-management

Behavioral

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

Comorbidities (detection/prevention)

Behavioral

Standardized assessment of comorbidities by nurses

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: COMEDSPA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2015
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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