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

July 30, 2020 updated by: Cécile Bottois, Hôpital Cochin

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Hopital Cochin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cécile Bottois, Dr
        • Sub-Investigator:
          • Ornella Conort, Dr
        • Sub-Investigator:
          • Maxime Dougados, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical consultation in the rheumatology department

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
Time Frame: 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.
6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation
Time Frame: 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.
6 months of follow-up
Satisfaction of patients on the pharmaceutical interview 3 months apart
Time Frame: 3 months of follow-up
Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.
3 months of follow-up
Change in rate of patients treated by biosimilar after the pharmaceutical consultation
Time Frame: 6 months of follow-up
Comparison of patient treated by biosimilar rate from baseline to M3 and M6 after the consultation
6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Cochin

Investigators

  • Principal Investigator: Cécile Bottois, Dr, Hopital Cochin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

July 31, 2020

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (ACTUAL)

August 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01380-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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