Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

Not Applicable

Completed

• Conditions: Treatment Adherence; Spondyloarthritis
• Interventions: Behavioral: Pharmacist's intervention

• Registration Number: NCT04001673
• Lead Sponsor: Dr Ornella Conort

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.

Study Timeline

• Study Start: 2017-02-15
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-15
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist's intervention	Pharmacist's intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, Ille De France, France