Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis Treated With Subcutaneous Biologic DMARDs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
研究概览
简要总结
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.
The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.
详细描述
This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.
Knowledge are assessed three time by self-administered questionnaire:
at baseline before the pharmacist's educational interview at three months apart at six months apart
One primary end-point is defined:
the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients must be able to understand and communicate in French and comply with the requirements of the study and must give his agreement (non-opposition) before any study assessment is performed.
- •Patient at least 18 years of age
- •Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or other)
- •Admission in medical consultation in the rheumatology department
- •Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab, Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab, Anakinra)
排除标准
- •Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from completing the study per protocol
结局指标
主要结局
Change in bDMARDS knowledge and skills at 3 and 6 months in patients who received a pharmaceutical consultation
时间窗: 6 months of follow-up
Knowledge level and score comparison (good or moderate or bad knowledge) evaluated by self-questionnaire (Biosecure) from baseline to M3 and M6 after the pharmaceutical consultation. Biosecure : Minimum = 0 ; Maximum = 100 Good knowledge \> 84 Moderate knoledge : 64 to 84 Bad knowledge \< 64 Higher scores mean a better outcome.
次要结局
- Change in bDMARDS adherence at 3 and 6 months in patients who received a pharmaceutical consultation(6 months of follow-up)
- Satisfaction of patients on the pharmaceutical interview 3 months apart(3 months of follow-up)
- Change in rate of patients treated by biosimilar after the pharmaceutical consultation(6 months of follow-up)
研究者
Cécile Bottois
Principal Investigator
Hôpital Cochin