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

Dr Ornella Conort

Status: Completed

Conditions: Treatment Adherence; Spondyloarthritis

Treatments: Behavioral: Pharmacist's intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04001673

2016-A01897-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Pharmacist's intervention

Active Comparator group

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.

Treatment:

Behavioral: Pharmacist's intervention

Control

No Intervention group

Description:

Evaluation of knowledge and adherence of patients treated by bDMARDs who did not receive pharmacist's intervention.