Hôpital Cochin
Paris, Ille de France, 75014, France
NCT Number: NCT04001673
There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.
The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, Ille de France, 75014, France
This is an interventional, controlled, open-label and monocentric study. 80 patients are planned to be included.
After written informed consent will be obtained, the patients will be randomized in two arms:
Two primary end-points are defined:
As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Information about bDMARDs management.
Time frame: 6 months of follow-up
MPR score comparison between the two arms after 6 month of follow up. MPR represents the number of subcutaneous bDMARDs supplied by a pharmacy divided by the number of theorical subcutaneous bDMARDs that the patient should have taken within the observation period (e.g. during the 4 months preceeding the baseline or the M6 visit), expressed in percentage.
Time frame: 6 months of follow-up
Knowledge level comparison (well-known, not known, partially known) evaluated by self-questionnaire between the two arms after 6 months of follow-up.
Time frame: 6 months of follow-up
BASDAI score comparison between the two arms after 6 month of follow up.
Time frame: 6 months of follow-up
Answer comparison to the 4-Likert self-questionnaire between the two arms after 6 months of follow-up. The Likert Scale is a four point scale, from not at all satisfied to completely satisfied.
Dr Ornella Conort
Other
Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
Acronym: SPADHESION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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