A Pragmatic RCT of Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Mean change from baseline in systolic blood pressure at 1-year
研究概览
简要总结
High blood pressure, also known as hypertension, affects nearly half of all Americans and increases the risk for heart disease and stroke. Only about half of people with high blood pressure have it under control. New methods to control blood pressure are needed to reduce heart attack and stroke rates. The purpose of this study is to test whether a digital program that includes personalized health coaching and remote patient monitoring with a connected blood pressure cuff, all delivered on a smartphone or website, can improve blood pressure control compared with usual care among patients with high blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Clinical diagnosis of hypertension
- •18+ years of age
- •English-speaking
- •Receives primary care at Stanford Primary Care
排除标准
- •<18 years of age
- •Primary language not English
- •Active or prior enrollment in Omada Program
研究组 & 干预措施
Does not receive access to Omada Health program
Participants manage hypertension with usual care alone.
Receives access to Omada Health program
In addition to usual care, participants will gain access to the Omada Program, an online program that offers lifestyle self-management support for hypertension. Participants will be assigned a health coach and a hypertension specialist via Omada's secure app. Participants will receive hypertension education and resources and communicate with their care team through asynchronous, in-app messaging features. Participants will receive digital tools that connect with the Omada app to help track their food intake, physical activity, and blood pressure (BP). Participants who also have diabetes will receive a digital blood glucose meter and/or a continuous glucose monitor as well. The care team will support patients with lifestyle self-management support, adherence to their current medication regimen, improved BP control, and use of monitors for self-management of their BP and/or blood glucose values.
干预措施: Omada Hypertension Program (Other)
结局指标
主要结局
Mean change from baseline in systolic blood pressure at 1-year
时间窗: Baseline, 1 year
次要结局
- Mean change from baseline in A1c at 1-year(Baseline, 1 year)
- Mean change from baseline in weight at 1-year(Baseline, 1 year)
研究者
Steven Lin
Clinical Associate Professor of Medicine
Stanford University