Skip to main content
OpenTrials
Completed

NCT Number: NCT04001673

Pharmaceutical Intervention and Adherence to bDMARDs in Spondyloarthritis.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin

Paris, Ille de France, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist's intervention

Behavioral

Information about bDMARDs management.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Changes in disease activity

    Time frame: 6 months of follow-up

    BASDAI score comparison between the two arms after 6 month of follow up.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dr Ornella Conort

Other

Registry information

Official study title

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

Acronym: SPADHESION

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2019
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.