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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499001
• Other study ID #: 2020-A01380-39
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2020
• Source: Hôpital Cochin
• Contact: Cécile Bottois, Dr
• Phone: +33 1 58 41 23 02
• Email: cecile.bottois[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Biological Therapy
• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• Pharmacist's consultation
Information about bDMARDs management.

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Cochin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation	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.	6 months of follow-up
Secondary	Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation	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.	6 months of follow-up
Secondary	Satisfaction of patients on the pharmaceutical interview 3 months apart	Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.	3 months of follow-up
Secondary	Change in rate of patients treated by biosimilar after the pharmaceutical consultation	Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation	6 months of follow-up