NCT04001673

Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dr Ornella Conort · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondyloarthritis
• Treatment Adherence

Interventions

Type	Name	Description
BEHAVIORAL	Pharmacist's intervention	Information about bDMARDs management.

Timeline

• Start date: 2017-02-15
• Primary completion: 2018-09-15
• Completion: 2018-09-15
• First posted: 2019-06-28
• Last updated: 2020-01-29

Locations

1 site across 1 country: France