Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499001
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2020-07-22
Brief Title:
Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs
Sponsor:
Hôpital Cochin
Organization:
Hôpital Cochin
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pharmacists educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis
The aim of this study is to assess the impact of a pharmacists 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 pharmacists 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
Knowledge are assessed three time by self-administered questionnaire
at baseline before the pharmacists 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None