Impact of a Pharmacist-Led Education Program on Medication Adherence and Treatment Effectiveness of Direct Oral Anticoagulants in Patients With Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
Atrial fibrillation (irregular heartbeat) increases the risk of stroke, and patients are commonly treated with direct oral anticoagulants (DOACs). However, when patients do not take these medications regularly, the drugs may not work effectively, increasing health risks.
In this study, called PharmAD-AF, specially trained pharmacists will meet with patients who have atrial fibrillation and are prescribed DOACs. They will offer personalized education and support to help patients take their medications as directed.
Researchers will compare groups of patients who receive this pharmacist-led education versus those who receive usual care. The main goals are to assess whether pharmacist support improves how consistently patients take their DOACs and how well the treatment prevents strokes while avoiding the side effects of DOAC therapy.
If successful, the study will demonstrate how pharmacist-led education can help patients stick to their treatment plan and reduce serious health risks, offering a practical way to improve heart-related care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •18 years of age or older
- •have a confirmed diagnosis of AF
- •are expected to begin DOAC therapy for at least 3 months for stroke prevention
排除标准
- •cannot understand DOAC-related education due to low literacy, language barriers, or cognitive impairment
- •have been on DOAC therapy for more than 6 months
- •using DOACs in off-label regimens
- •are pregnant or breastfeeding
研究组 & 干预措施
Patient education
Patients in this arm will receive a comprehensive DOAC education from trained pharmacists.
干预措施: Pharmacist-led patient education (Behavioral)
Usual care
Patients in this arm will receive only usual care, without pharmacists providing additional DOAC education materials.
干预措施: Usual Care (Other)
结局指标
主要结局
Medication adherence
时间窗: Medication adherence will be measured at 3 months and 6 months after the baseline visit.
Patients' adherence to DOACs will be assessed using the Adherence to Refills and Medications Scale (ARMS). The ARMS is a 12-item scale, including eight items on medication-taking adherence and four items on refill adherence. The total score ranges from 12 to 48, with higher scores indicating greater barriers to adherence. Unit of Measure: Score (points).
次要结局
- Composite thromboembolic events(Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit)
- Composite major bleeding events(Composite bleeding events will be measured at 1 year and 2 years after the baseline visit)
研究者
Chi-Chuan Wang
Associate Professor
National Taiwan University