Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

Dr Ornella Conort80 enrolled

Overview

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: * Intervention arm: intervention of a pharmacist who will explain bDMARDs management. * Control arm, without intervention. Two primary end-points are defined: 1. the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Spondyloarthritis Treatment Adherence

Interventions

Pharmacist's interventionBEHAVIORAL

Information about bDMARDs management.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital Cochin

Paris, Ille de France, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months of follow-up

Secondary Outcomes

Changes in disease activity

BASDAI score comparison between the two arms after 6 month of follow up.

Time frame: 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.

Time frame: 6 months of follow-up

Data from ClinicalTrials.gov

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