Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

Spondyloarthritis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001673
• Other study ID #: 2016-A01897-44
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: September 15, 2018

Study information

• Verified date: January 2020
• Source: Hôpital Cochin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis
• Treatment Adherence

Intervention

Behavioral:
• Pharmacist's intervention
Information about bDMARDs management.

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris	Ille De France

Sponsors (1)

Lead Sponsor	Collaborator
Dr Ornella Conort

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in disease activity	BASDAI score comparison between the two arms after 6 month of follow up.	6 months of follow-up
Secondary	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.	6 months of follow-up