COMorbidities and EDucation in SPondyloArthritis Study

NCT02374749 | Completed

• 1 other identifier: P140401
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

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

Conditions

Axial Spondyloarthritis

Keywords

Axial Spondyloarthritis; Education; Co-morbidities; Nurse

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Frequency of comorbidities in Spondyloarthritis

  1 year later

• Frequency of compliance with general recommendations on vaccinations, screening for certain cancers and osteoporosis screening

  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

  1 year later

• Patient compliance program self-management of Spondyloarthritis

  1 year later

Study Arms (2)

comorbidities

ACTIVE COMPARATOR

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)

self-assessment

ACTIVE COMPARATOR

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

Interventions

self-assessment/self-management BEHAVIORAL

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

self-assessment

Comorbidities (detection/prevention) BEHAVIORAL

Standardized assessment of comorbidities by nurses

comorbidities

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to understand and adhere to the study treatments
• Development of a medical examination results given to the patient
• Informed Consent signed and dated

You may not qualify if:

• Pregnant women (any method of contraception will be accepted)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (2)

• Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen-Witrand A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA). Rheumatology (Oxford). 2021 Feb 1;60(2):888-895. doi: 10.1093/rheumatology/keaa480.

  PMID: 33063096 BACKGROUND

• Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial. Semin Arthritis Rheum. 2020 Aug;50(4):701-708. doi: 10.1016/j.semarthrit.2020.05.012. Epub 2020 May 27.

  PMID: 32521324 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Comorbidity

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maxime DOUGADOS, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: March 2, 2015
• Study Start: March 23, 2015
• Primary Completion: October 16, 2017
• Study Completion: October 16, 2017
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

FR (1)