Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spondyloarthritis
- Sponsor
- Dr Ornella Conort
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Dr Ornella Conort
Pharmacist
Hôpital Cochin
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
Time Frame: 6 months of follow-up
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.
Improvement in knowledge about bDMARDs management.
Time Frame: 6 months of follow-up
Knowledge level comparison (well-known, not known, partially known) evaluated by self-questionnaire between the two arms after 6 months of follow-up.
Secondary Outcomes
- Changes in disease activity(6 months of follow-up)
- Satisfaction of patients after receiving pharmacist's intervention(6 months of follow-up)