An observational study in Arthritis, Rheumatoid, Spondyloarthritis and Biological Therapy, sponsored by Hôpital Cochin. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Hôpital Cochin · Observational
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.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 60 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Hôpital Cochin is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with subcutaneous bDMARDs with inflammatory arthritis admitted in medical consultation in the rheumatology department
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Exclusion Criteria:
Information about bDMARDs management.
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.
Time frame: 6 months of follow-up
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.
Time frame: 6 months of follow-up
Satisfaction of patients on the pharmaceutical interview 3 months apart
Assessment of patients' satisfaction on the pharmaceutical interview at 3 months of the consultation.
Time frame: 3 months of follow-up
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
Time frame: 6 months of follow-up
Plan to share: No
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Hôpital Cochin