The Effect of an Artificial Intelligence-based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Average change in DBP from baseline to 24 weeks
研究概览
简要总结
This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Age ≥18 years
- •Stage 2 hypertension based on their most recent clinical measurement (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg per the 2017 American College of Cardiology/American Heart Association guidelines)
- •Speaking and reading English
- •Having an Apple iPhone 6s or later, or an Android phone running Android 8.0 or later
排除标准
- •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
结局指标
主要结局
Average change in DBP from baseline to 24 weeks
时间窗: 24 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks
时间窗: 12 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks
时间窗: 24 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks
时间窗: 24 weeks
Average change in systolic blood pressure (SBP) from baseline to 12 weeks
时间窗: 12 weeks
Average change in diastolic blood pressure (DBP) from baseline to 12 weeks
时间窗: 12 weeks
Average change in SBP from baseline to 24 weeks
时间窗: 24 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks
时间窗: 12 weeks
次要结局
- Average weekly percentage of active participants measuring their BP(24 weeks)
- Average weekly percentage of active participants syncing their wearable(24 weeks)
- Average weekly percentage of active participants answering the mobile app questionnaire(24 weeks)
- Number of manual clinician outreaches based on the escalation rules set for the study(24 weeks)
研究者
Sujit Dey
Principal Investigator
University of California, San Diego