Spondyloarthritis, Treatment Adherence
Conditions
Keywords
treatment knowledge
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.
Interventions
BEHAVIORALPharmacist's intervention
Information about bDMARDs management.
Sponsors
Dr Ornella Conort
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in disease activity | 6 months of follow-up | BASDAI score comparison between the two arms after 6 month of follow up. |
| Satisfaction of patients after receiving pharmacist's intervention | 6 months of follow-up | 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. |
Countries
France
Outcome results
None listed