A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 2
- 主要终点
- Change in systolic blood pressure (SBP)
研究概览
简要总结
This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.
详细描述
The primary and secondary outcomes will be determined in months 1 & 2. Participants will continue for another 4 months and during that time data for exploratory measures will be collected.
During the first 2 months of the study, a micro-randomized trial (MRT) will be performed within the App+JITAI group (N=200). This MRT is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants randomized to the App+JITAI will receive push notifications throughout the study, while those in the App alone group will not. The participants will not be told the group in which they are randomized, but they may know the group because of the number of push notifications.
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
- •Diagnosed with essential hypertension (HTN) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (EHR) and confirmed by participant self-report.
- •A smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications
- •A valid email address
- •Fluent in spoken and written English
排除标准
- •Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 mmHg)
- •Contraindication to a sodium restriction diet
- •An estimated sodium intake less than 1,500mg per day
- •Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
- •Estimated glomerular filtration rate (EGFR) <30 or end-stage renal disease on dialysis
- •Heart failure
- •Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications
- •Currently pregnant or intent to become pregnant during the study period
结局指标
主要结局
Change in systolic blood pressure (SBP)
时间窗: Baseline, 2 months
SBP measured by a wireless home blood pressure monitor
次要结局
- Percent of participants at a goal blood pressure (BP)(2 months)
- Changes in blood pressure (BP) medications(Baseline, 2 months)
- Change in weight over 2 months(Baseline, 2 months)
- Change in estimated sodium intake(Baseline, 2 months)
- Change in dietary nutrient intake(Baseline, 2 months)
研究者
Brahmajee K Nallamothu
Stevo Julius Research Professor of Cardiovascular Medicine and Professor of Internal Medicine
University of Michigan