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There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.
The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.
This is an interventional, controlled, open-label and monocentric study. 80 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
Two primary end-points are defined:
As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist's intervention | Active Comparator | Evaluation of knowledge and adherence of patients treated by bDMARDs before and after the intervention of a pharmacist that will give information concerning bDMARDs management. |
|
| Control | No Intervention | Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist's intervention | Behavioral | Information about bDMARDs management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention. | MPR score comparison between the two arms after 6 month of follow up. MPR represents the number of subcutaneous bDMARDs supplied by a pharmacy divided by the number of theorical subcutaneous bDMARDs that the patient should have taken within the observation period (e.g. during the 4 months preceeding the baseline or the M6 visit), expressed in percentage. | 6 months of follow-up |
| Improvement in knowledge about bDMARDs management. | Knowledge level comparison (well-known, not known, partially known) evaluated by self-questionnaire between the two arms after 6 months of follow-up. | 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in disease activity | BASDAI score comparison between the two arms after 6 month of follow up. | 6 months of follow-up |
| Satisfaction of patients after receiving pharmacist's intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | Ille de France | 75014 | France |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Answer comparison to the 4-Likert self-questionnaire between the two arms after 6 months of follow-up. The Likert Scale is a four point scale, from not at all satisfied to completely satisfied.
| 6 months of follow-up |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |