Interest of a Standardized Monitoring of Rheumatoid Arthritis: The COMEDRA Trial
- Conditions
- Rheumatoid Arthritis
- Interventions
- Behavioral: Auto-DASBehavioral: Comorbidities treatment
- Registration Number
- NCT01315652
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 970
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Auto DAS Auto-DAS "Auto-DAS"Number of patients with a modification in their treatment between baseline and 6 months visits Comorbidities treatment Comorbidities treatment -
- Primary Outcome Measures
Name Time Method Comorbidities treatment 6 months later Number of actions initiated I order to treat or prevent Rheumatoid Arthritis comorbidities
Auto-DAS: Patient education to calculate his Disease Activity Score 6 months after Number of patients with a modification in their treatment between baseline and 6 months visits
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hôpital Cochin
🇫🇷Paris, France