Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis. (SPADHESION)
Primary Purpose
Spondyloarthritis, Treatment Adherence
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmacist's intervention
Sponsored by
About this trial
This is an interventional other trial for Spondyloarthritis focused on measuring treatment knowledge
Eligibility Criteria
Inclusion Criteria:
- 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
- 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:
- Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion
- History of psychological problems
- Patients who need other persons to manage their treatment.
Sites / Locations
- Hôpital Cochin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pharmacist's intervention
Control
Arm Description
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.
Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Changes in disease activity
BASDAI score comparison between the two arms after 6 month of follow up.
Satisfaction of patients after receiving pharmacist's intervention
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04001673
Brief Title
Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.
Acronym
SPADHESION
Official Title
Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Ornella Conort
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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:
Intervention arm: intervention of a pharmacist who will explain bDMARDs management.
Control arm, without intervention.
Two primary end-points are defined:
the changes from baseline to M6 in the patients' knowledge score about subcutaneous bDMARD management
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Treatment Adherence
Keywords
treatment knowledge
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist's intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention.
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist's intervention
Intervention Description
Information about bDMARDs management.
Primary Outcome Measure Information:
Title
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
Description
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
Title
Improvement in knowledge about bDMARDs management.
Description
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
Secondary Outcome Measure Information:
Title
Changes in disease activity
Description
BASDAI score comparison between the two arms after 6 month of follow up.
Time Frame
6 months of follow-up
Title
Satisfaction of patients after receiving pharmacist's intervention
Description
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.
Time Frame
6 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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:
Patients who have had a change in the treatment of SpA during the 3 months prior or after the inclusion
History of psychological problems
Patients who need other persons to manage their treatment.
Facility Information:
Facility Name
Hôpital Cochin
City
Paris
State/Province
Ille De France
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.
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