Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.
NCT ID: NCT04001673
Last Updated: 2020-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2017-02-15
2018-09-15
Brief Summary
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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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Detailed Description
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After written informed consent will be obtained, the patients will be randomized in two arms:
* Intervention arm: intervention of a pharmacist who will explain bDMARDs management.
* Control arm, without intervention.
Two primary end-points are defined:
1. the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management
2. the changes from baseline to M6 in Medication Possession Ratio (MPR)
As secondary end-points, the changes in disease activity and patients' satisfaction regarding the pharmacists' intervention are evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Pharmacist's intervention
Evaluation of knowledge and adherence of patients treated by bDMARDs before and after the intervention of a pharmacist that will give information concerning bDMARDs management.
Pharmacist's intervention
Information about bDMARDs management.
Control
Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention.
No interventions assigned to this group
Interventions
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Pharmacist's intervention
Information about bDMARDs management.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Spondyloarthritis
* Under treatment with subcutaneous bDMARDs for at least 6 months
* Disease activity stable for at least 6 months
* No treatment modification 3 months before or after inclusion in the study
* Informed consent signed and dated
* Older than 18 years
* Patients who speak french
Exclusion Criteria
* History of psychological problems
* Patients who need other persons to manage their treatment.
18 Years
ALL
No
Sponsors
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Dr Ornella Conort
OTHER
Responsible Party
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Dr Ornella Conort
Pharmacist
Locations
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Hôpital Cochin
Paris, Ille de France, France
Countries
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Other Identifiers
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2016-A01897-44
Identifier Type: -
Identifier Source: org_study_id
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