Connected Health Blood Pressure Monitoring In Stroke and TIA Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed
研究概览
简要总结
The goal of this pilot project is to assess adherence with home blood pressure monitoring in hypertensive patients with a history of cerebral infarction and to determine if a social incentive improves adherence with monitoring. Enrolled subjects will all have a history of cerebral infarction and uncontrolled blood pressure, defined by SBP>140 or DBP>90 mm Hg at the time of enrollment. To be eligible subjects will also be required to own a smart phone (iOS or Android operating system). After enrollment, patients will be given a home blood pressure cuff with instructions to monitor their BP twice daily for 90 days. Subjects will be randomly assigned to a social incentive program, in which a social supporter receives updates via email and/or text message on the subject's adherence with BP monitoring and their average blood pressure. This study will provide important pilot data which will inform the design of future studies utilizing connected health and automated systems to improve home blood pressure monitoring and blood pressure control in patients with a history of stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult, age ≥ 18 years
- •History of ischemic stroke or high risk TIA (defined by ABCD2 ≥ 4)between 2 weeks and 12 months prior to enrollment
- •Hypertensive at time of enrollment, defined by SBP>140 mm Hg or DBP >90 mm Hg at the time of study screening
- •Must own a smart phone capable of interacting with the connected blood pressure cuff (Apple iPhone 3GS or higher; Android 4.0 or higher with Bluetooth connectivity)
- •Willingness and ability to sign informed consent by patient
排除标准
- •Moderate or severe disability, defined by modified Rankin Scale ≥
- •Expected residence in a rehabilitation hospital, nursing facility or assisted living community during the study period.
- •Upper arm circumference <9 inches or >17 inches
- •Inability to monitor BP in both of the upper arms (i.e. history of bilateral radical mastectomy, bilateral severe subclavian stenosis, or bilateral arterial venous fistulas for dialysis).
- •Blood pressure discrepancy between arms of >10 mm Hg.
- •Inability to follow-up at 90 days and return BP monitor
- •Active participation in another clinical trial
- •Pregnant women
结局指标
主要结局
Adherence With Home Blood Pressure Monitoring, Defined by the Proportion of Home Blood Pressure Recordings Successfully Completed
时间窗: 90 Days
Percentage of requested blood pressure measurements completed. Note that subjects were enrolled for 90 +/- 7 days, and so this calculation was completed at day 83, rather than day 90.
次要结局
- Number of Physician Visits(90 days)
- Number of Emergency Department Visits(90 days)
- Number of Patients Who Felt They Had Well-controlled Blood Pressure(90 days)
- Change in Systolic Blood Pressure Over Study Period(90 days)
- Number of Changes in Antihypertensive Medications (Dose Adjustment or Addition of a New Agent)(90 days)
- Number of Participates That Perceived the Blood Pressure Monitoring Device to be Easy to Use(90 days)
- Number of Patients That Perceived Blood Pressure Monitoring to be Useful(90 days)