Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Improvement in bDMARDS adherence at 6 months in patients who received a pharmaceutical intervention.
时间窗: 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.
Improvement in knowledge about bDMARDs management.
时间窗: 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.
次要结局
- Changes in disease activity(6 months of follow-up)
- Satisfaction of patients after receiving pharmacist's intervention(6 months of follow-up)
研究者
Dr Ornella Conort
Pharmacist
Hôpital Cochin