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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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:
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:
The two primary objectives of this trial are :
The Secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| self-assessment | Active Comparator | During the initial visit, the clinical research nurse exempt a learning program of assessment of disease activity/severity :
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-assessment/self-management | Behavioral | Nurse led-program of self-assessment/ self-management of spondyloarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of comorbidities in Spondyloarthritis | This analysis will be purely descriptive and will include the percentage of patients with:
|
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Maxime DOUGADOS, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33063096 | Result | 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. | |
| 32521324 |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D015897 | Comorbidity |
| ID | Term |
|---|---|
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
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| Comorbidities (detection/prevention) | Behavioral | Standardized assessment of comorbidities by nurses |
|
| 1 year later |
| 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 |
| 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 |
| 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 |
| Result |
| 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. |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D004778 | Environment and Public Health |