NCT05154929已完成不适用
Improving Blood Pressure Control Through the myBPmyLife mHealth Application: A Wearables in Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) Center Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 4
- 主要终点
- Change in systolic blood pressure between baseline and 6-months
研究概览
简要总结
This study is enrolling eligible participants that have high blood pressure. Reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. This trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. All study activities will be completed online or via a mobile medical application. Participants will not have any face-to-face visits with the study team.
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
- •Self-reported history of hypertension and no hypertensive medication changes in the last 4 weeks.
- •A smartphone with a compatible Apple or Android operating system installed and able to download and use the myBPmyLife app including accepting all permissions
- •A valid email address
- •Fluent in spoken and written English
- •Signed written informed consent. (Note that each participant must be able to consent for themselves.)
排除标准
- •Contraindication to performing physical activity or following a sodium restriction diet. The participant must be able to walk and eat on their own without assistive devices.
- •Unstable symptoms or markedly elevated BP at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 millimeters of mercury (mmHg))
- •Known secondary causes of hypertension (e.g., adrenal insufficiency, pheochromocytoma), heart failure, or end-stage renal disease
- •Difficulty using an upper arm blood pressure cuff due to biceps size or end-stage renal disease or difficulty comfortably wearing a smartwatch
- •Wrist too large to wear a smartwatch comfortably.
- •Daily sodium intake less than 1500 mg/day as measured by the sodium screener
- •Currently pregnant or planning to become pregnant in the next six months
结局指标
主要结局
Change in systolic blood pressure between baseline and 6-months
时间窗: Baseline, 6 months
次要结局
- Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)(Baseline, every 60 days from 0 days to 60 days to 120 days to 180 days (i.e., approximately 2 months))
- Number of self-reported low-sodium food choices within 24 hours of a diet notification(within 24 hours of a diet notification)
- Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)(Baseline, up to 6 months)
- Number of steps taken within 60 minutes of a physical activity notification(within 60 minutes of a physical activity notification)
- Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)(Baseline, up to 6 months)
- Trends in weekly systolic BP over the 6-months (i.e., 180 days)(Baseline to weekly assessments that are available up to 24 weeks)
- Change in mean daily step count between baseline and 6-months (i.e., 180 days)(Baseline, up to 6 months)
- Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire(Baseline, up to 6 months)
研究者
Brahmajee K Nallamothu
Professor of Internal Medicine
University of Michigan
研究点 (4)
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