Testing Strategies to Improving Warfarin Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- anticoagulation control
研究概览
简要总结
We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the Med-eMonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. Half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the Med-eMonitor only.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years old age or older
- •On warfarin managed at the AC clinic
- •Target INR 2.0-3.0 or 2.5-3.5
- •At maintenance phase of therapy (defined as stable INR with stable warfarin dosing over at least 2 consecutive visits)
排除标准
- •Do not have access to telephone line
- •Unwillingness to participate or to sign a consent form(refusal)
- •Inability to participate because of advances dementia, advanced Alzheimer's disease or other impairment affecting ability to provide informed consent and/or quality data or utilize the Med-eMonitor
- •Participation in a current study that does not permit participation in another study
- •End stage or terminal illness with anticipated life expectancy of 6 months or less
- •INR over the upper limit for the individual's range at the time of enrollment (e.g.,>3.0 or >3.5, depending on the target range)
- •Diagnosed with antiphospholipid antibody syndrome or abnormal INR prior to starting warfarin
研究组 & 干预措施
2
50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence
干预措施: Non-Lottery (Med-eMonitor only) (Behavioral)
1
50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence
干预措施: Lottery arm (Lottery and Med-eMonitor) (Behavioral)
结局指标
主要结局
anticoagulation control
时间窗: six months
次要结局
- adherence(six months)