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There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.
The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.
This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.
Knowledge are assessed three time by self-administered questionnaire:
at baseline before the pharmacist's educational interview at three months apart at six months apart
One primary end-point is defined:
the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)
As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence, patients' satisfaction regarding the pharmacists' intervention and the effect of the interview on rate of patients treated by biosimilar are evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist's consultation | Other | Information about bDMARDs management. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation | Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation. Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge > 84 Moderate knoledge : 64 to 84 Bad knowledge < 64 Higher scores mean a better outcome. | 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation | Adherence level comparison (high or low adherence) evaluated by self-questionnaire, Compliance Questionnaire for Rheumatology (CQR-5) from baseline to M3 and M6 after the consultation. High adherence means a better outcome. | 6 months of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical consultation in the rheumatology department
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile Bottois, Dr | Contact | +33 1 58 41 23 02 | cecile.bottois@aphp.fr | |
| Ornella Conort, Dr | Contact | + 33 1 58 41 23 07 | ornella.conort@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cécile Bottois, Dr | Hôpital Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Recruiting | Paris | France |
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| Satisfaction of patients on the pharmaceutical interview 3 months apart | Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation. | 3 months of follow-up |
| Change in rate of patients treated by biosimilar after the pharmaceutical consultation | Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation | 6 months of follow-up |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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