NCT04815161Unknown不适用
ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
Oslo University Hospital0 个研究点目标入组 200 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Rate of adherence
研究概览
简要总结
The ASTORIA study is a prospective cohort single-armed multicenter observational study that aims to assess adherence to rivaroxaban using a high technological electronical pillbox connected to a phone application in a group of atrial fibrillation patients with indication of long term anticoagulation treatment in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female or male patient with age > 18 years
- •Patients with atrial fibrillation
- •Patients initiated, continued on or switched to rivaroxaban for the indication atrial fibrillation with intended lifelong treatment (CHA2 DS2-VASc score ≥ 1).
- •The patient must agree to the use of the electronic medication adherence monitoring device, the so-called Pilloxa box and need to have a sufficient understanding of the app and functionality in conjunction with the use of the Pilloxa box.
- •Signed informed consent
- •No participation in an investigational program with interventions outside of routine clinical practice
- •No contra-indications according to the local marketing authorization
排除标准
- •Participation in an investigational program with interventions outside of routine clinical practice
- •Contra-indications according to the local marketing authorization
结局指标
主要结局
Rate of adherence
时间窗: 2 years
The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.
次要结局
- Persistence rate(2 years)
- Rates of different patient experiences(2 years)
- Rates of risk factors(2 years)
研究者
Dan Atar
Principal Investigator
Oslo University Hospital
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