Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Average change in systolic blood pressure (SBP) in experimental vs. control group
研究概览
简要总结
In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years
- •SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office
- •speaking and reading English
- •having an iPhone 8 or newer or an Android x or newer
排除标准
- •currently taking antihypertensive medication
- •self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
- •current participation in a lifestyle modification program or research study
- •self-report of being currently pregnant
研究组 & 干预措施
AI-Based Lifestyle Recommendations Group
Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data.
干预措施: AI-Based Lifestyle Recommendations (Behavioral)
Control Group
Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor.
干预措施: No Lifestyle Recommendations (Other)
结局指标
主要结局
Average change in systolic blood pressure (SBP) in experimental vs. control group
时间窗: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient.
Average change in diastolic blood pressure (DBP) in experimental vs. control group
时间窗: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient.
次要结局
- Number of patients in experimental group that followed lifestyle recommendations(Initial 2 week data collection, weekly lifestyle recommendations, 6 months total)
研究者
Sujit Dey
Principal Investigator
University of California, San Diego