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

NCT04499001 | Unknown

• 1 other identifier: 2020-A01380-39
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid; Spondyloarthritis; Biological Therapy

Keywords

knowledge; safety skills; pharmaceutical consultation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation

  6 months of follow-up

• Satisfaction of patients on the pharmaceutical interview 3 months apart

  3 months of follow-up

• Change in rate of patients treated by biosimilar after the pharmaceutical consultation

  6 months of follow-up

Interventions

Pharmacist's consultation OTHER

Information about bDMARDs management.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Cochin: lead

Study Sites (1)

Hôpital Cochin

Paris, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases

Study Officials

• Cécile Bottois, Dr

  Hôpital Cochin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Bottois, Dr

CONTACT

+33 1 58 41 23 02; cecile.bottois@aphp.fr

Ornella Conort, Dr

CONTACT

+ 33 1 58 41 23 07; ornella.conort@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 5, 2020
• Study Start: October 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)