Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Intervention arm: intervention of a pharmacist who will explain bDMARDs management. Control arm, without intervention. Two primary end-points are defined: the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management the changes from baseline to M6 in Medication Possession Ratio (MPR) As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.

Official Title
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Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.

Conditions
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Spondyloarthritis, Treatment Adherence

Intervention / Treatment
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* Behavioral: Pharmacist's intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients from Rheumatology Department at Cochin Hospital Diagnosis of Spondyloarthritis Under treatment with subcutaneous bDMARDs for at least 6 months Disease activity stable for at least 6 months No treatment modification 3 months before or after inclusion in the study Informed consent signed and dated Older than 18 years Patients who speak french Exclusion Criteria: Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion History of psychological problems Patients who need other persons to manage their treatment.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacist's intervention<br>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. | Behavioral: Pharmacist's intervention<br>* Information about bDMARDs management.<br>|
| No Intervention: Control<br>Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment knowledge