Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial

Study Overview
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Brief Summary
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The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment…), cancers (e.g.mammography,…), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).

Detailed Description
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Patients with a stable definite Rheumatoid Arthritis will be invited by their rheumatologists to participate at this study in 20 centers in France. After written informed consent will be obtained, the patients will be randomized in two arms: comorbidities auto-DAS The patients will be seen again in the same center six months later in order to collect the outcome measures.

Official Title
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Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Comorbidities treatment
* Behavioral: Auto-DAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid Arthritis Stable (no change in therapy) Adult Able to collaborate Exclusion criteria Pregnant woman Change of the therapy for 3 months before the inclusion Alcoholism, toxicomania, psychological problem, sever co morbidity which could invalid the consent or limit the protocol compliance No social coverage affiliate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auto DAS<br>Auto-DASNumber of patients with a modification in their treatment between baseline and 6 months visits | Behavioral: Auto-DAS<br>* Auto-DASNumber of patients with a modification in their treatment between baseline and 6 months visits<br>|
| Active Comparator: Comorbidities treatment<br> | Behavioral: Comorbidities treatment<br>*  Comorbidities treatment:Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities treatment | Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities | 6 months later | 
| Auto-DAS: Patient education to calculate his Disease Activity Score | Number of patients with a modification in their treatment between baseline and 6 months visits | 6 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of comorbidities in Rheumatoid Arthritis |  | 6 months later | 
| Adhesion to the current recommendations concerning the prevention of co-morbidities |  | 6 months later | 
| Compliance and satisfaction of the patients concerning the DAS educational program |  | 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1 Rheumatoid arthritis, 2 Education, 3 Co-morbidities, 4 Nurse