Clinical trial NCT04499001: Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Spondyloarthritis
Biological Therapy
Keywords: knowledge
safety skills
pharmaceutical consultation
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical consultation in the rheumatology department

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
timeFrame: 6 months of follow-up
Secondary outcomes:
measure: Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation
timeFrame: 6 months of follow-up
measure: Satisfaction of patients on the pharmaceutical interview 3 months apart
timeFrame: 3 months of follow-up
measure: Change in rate of patients treated by biosimilar after the pharmaceutical consultation
timeFrame: 6 months of follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Hôpital Cochin
name: Cécile Bottois, Dr
role: PRINCIPAL_INVESTIGATOR
References: