Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 898
- 试验地点
- 23
- 主要终点
- Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention
研究概览
简要总结
Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy.
The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients can be included if ALL the following criteria are met:
- •Provide written informed consent prior to participation
- •Female or male adult patients aged ≥ 20 years and < 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment.
排除标准
- •Patients should not be included if ANY ONE of the following criteria is met:
- •Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran [e.g., anaphylactic reaction or anaphylactic shock], severely impaired renal function [Creatinine clearance rate (Ccr) < 30 mL/min], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole)
- •Participate in other interventional trials currently or in the past 30 days
研究组 & 干预措施
SOC with advanced educational intervention
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention.
The educational intervention was based on material of the "Shared decision making of treatment of New Oral AntiCoagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.
干预措施: Dabigatran (Drug)
Standard of care (SOC) only
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
干预措施: Dabigatran (Drug)
结局指标
主要结局
Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention
时间窗: at 12 months
Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
次要结局
- Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention(at 3, 6, and 9 months)
- Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention(At 3, 6, 9, and 12 months)
- Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention(At 3, 6, 9, and 12 months)
- Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention(At 3, 6, 9, and 12 months)
- Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention(up to 12 months)
- Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention(up to 12 months)
- Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention(up to 12 months)