Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- anticoagulation compliance
研究概览
简要总结
There is a need to determine actual compliance of direct oral anticoagulants and how to improve this to reduce risk of stroke in patients with atrial fibrillation. Mobile health tools have been implemented world-wide in various patient populations as means of reducing cardiovascular risk and improving disease management. Results of these interventions have been mixed with some interventions demonstrating significant improvement while others demonstrated no difference between the intervention group and the control group. More importantly, these studies indicate that implementation of mobile health tools is feasible in various patient populations and it may just be a matter of finding the correct intervention for a given disease state. The aim of this study is to increase awareness of atrial fibrillation as a means of improving compliance with anticoagulant medication.
详细描述
The primary hypothesis of this study is that patients with atrial fibrillation will have improved compliance with apixaban therapy if they complete a daily measurement of heart rhythm via a smartphone electrocardiogram monitor, as compared to patients managed in a conventional manner.
Primary Endpoint
- Primary Endpoint 1: is the percent compliance with apixaban therapy as measured by the amount of apixaban medication that was consumed per month. Compliance is defined as "the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen." Percent compliance will be measured as a continuous variable and strict cutoffs for 'compliant' and 'non-compliant' status will not be imposed.
Secondary Endpoints 2. Secondary Endpoint 1: is the number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure. Given the low numbers of patients in this study, this will be a composite endpoint of all of these outcomes, since there is insufficient sample size to examine each outcome individually. 3. Secondary Endpoint 2: is the self assessment of atrial fibrillation symptom severity through the use of a standardized scale.
While the secondary endpoints are not directly related to the primary endpoint, there is a possibility that the intervention may lead to changes in health maintenance behavior, which may lead to differences in the secondary endpoints. While this study may not be powered to differentiate between these secondary endpoints, if a trend is noted, this may be hypothesis generating for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Non-valvular atrial fibrillation that is either paroxysmal, persistent or permanent
- •CHA2DS2VASc score of 2 or more
- •Eligible for therapy with apixaban for at least 6 months
- •Possession of a smartphone capable of pairing with the AliveCor Kardia cardiac monitor
排除标准
- •Contraindication to anticoagulation with apixaban for at least 6 months
- •No access to a smartphone capable of pairing with the AliveCor Kardia cardiac monitor
- •Unable to provide informed consent for this protocol
结局指标
主要结局
anticoagulation compliance
时间窗: 12 months
percent compliance with apixaban therapy
次要结局
- AF symptom severity(12 months)
- composite of deaths, strokes, and hospitalizations(12 months)