Rheumatoid Arthritis
Conditions
Keywords
1 Rheumatoid arthritis, 2 Education, 3 Co-morbidities, 4 Nurse
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.
Interventions
BEHAVIORALComorbidities treatment
Comorbidities treatment:Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up
BEHAVIORALAuto-DAS
Auto-DASNumber of patients with a modification in their treatment between baseline and 6 months visits
Sponsors
1 French Society of Rheumatology
Roche Chugai
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
France
Outcome results
None listed