Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs

• Conditions: Arthritis, Rheumatoid; Spondyloarthritis; Biological Therapy

• Registration Number: NCT04499001
• Lead Sponsor: Hôpital Cochin

Brief Summary

There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.

The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.

Detailed Description

This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.

Knowledge are assessed three time by self-administered questionnaire:

at baseline before the pharmacist's educational interview at three months apart at six months apart

One primary end-point is defined:

the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)

As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence, patients' satisfaction regarding the pharmacists' intervention and the effect of the interview on rate of patients treated by biosimilar are evaluated.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients must be able to understand and communicate in French and comply with the requirements of the study and must give his agreement (non-opposition) before any study assessment is performed.
• Patient at least 18 years of age
• Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or other)
• Admission in medical consultation in the rheumatology department
• Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab, Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab, Anakinra)

Exclusion Criteria

• Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from completing the study per protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation	6 months of follow-up	Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation.; Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge \> 84 Moderate knoledge : 64 to 84 Bad knowledge \< 64; Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation	6 months of follow-up	Adherence level comparison (high or low adherence) evaluated by self-questionnaire, Compliance Questionnaire for Rheumatology (CQR-5) from baseline to M3 and M6 after the consultation.; High adherence means a better outcome.
Satisfaction of patients on the pharmaceutical interview 3 months apart	3 months of follow-up	Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.
Change in rate of patients treated by biosimilar after the pharmaceutical consultation	6 months of follow-up	Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France