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

NCT ID: NCT04499001

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Arthritis, Rheumatoid Spondyloarthritis Biological Therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Pharmacist's consultation

Information about bDMARDs management.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Cochin

OTHER

Sponsor Role lead

Responsible Party

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Cécile Bottois

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cécile Bottois, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cochin

Locations

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Hôpital Cochin

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile Bottois, Dr

Role: CONTACT

+33 1 58 41 23 02

Ornella Conort, Dr

Role: CONTACT

+ 33 1 58 41 23 07

Facility Contacts

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Cécile Bottois, Dr

Role: primary

+33 1 58 41 23 02

Ornella Conort, Dr

Role: backup

+33 1 58 41 23 07

Other Identifiers

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2020-A01380-39

Identifier Type: -

Identifier Source: org_study_id

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