Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis. (SPADHESION)

January 27, 2020 updated by: Dr Ornella Conort

Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ille De France
      • Paris, Ille De France, France, 75014
        • Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Pharmacist's intervention
Information about bDMARDs management.
No Intervention: Control
Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
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.
6 months of follow-up
Improvement in knowledge about bDMARDs management.
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.
6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in disease activity
Time Frame: 6 months of follow-up
BASDAI score comparison between the two arms after 6 month of follow up.
6 months of follow-up
Satisfaction of patients after receiving pharmacist's intervention
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.
6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Ornella Conort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

September 15, 2018

Study Completion (Actual)

September 15, 2018

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01897-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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