Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.
SPADHESION
Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedFirst Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedJanuary 29, 2020
January 1, 2020
1.6 years
June 26, 2019
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
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.
6 months of follow-up
Improvement in knowledge about bDMARDs management.
Knowledge level comparison (well-known, not known, partially known) evaluated by self-questionnaire between the two arms after 6 months of follow-up.
6 months of follow-up
Secondary Outcomes (2)
Changes in disease activity
6 months of follow-up
Satisfaction of patients after receiving pharmacist's intervention
6 months of follow-up
Study Arms (2)
Pharmacist's intervention
ACTIVE COMPARATOREvaluation of knowledge and adherence of patients treated by bDMARDs before and after the intervention of a pharmacist that will give information concerning bDMARDs management.
Control
NO INTERVENTIONEvaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention.
Interventions
Eligibility Criteria
You may qualify if:
- Outpatients from Rheumatology Department at Cochin Hospital
- Diagnosis of Spondyloarthritis
- Under treatment with subcutaneous bDMARDs for at least 6 months
- Disease activity stable for at least 6 months
- Informed consent signed and dated
- Older than 18 years
- Patients who speak french
You may not qualify if:
- History of psychological problems
- Patients who need other persons to manage their treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Cochin
Paris, Ille de France, 75014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Pharmacist
Study Record Dates
First Submitted
June 26, 2019
First Posted
June 28, 2019
Study Start
February 15, 2017
Primary Completion
September 15, 2018
Study Completion
September 15, 2018
Last Updated
January 29, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share