Technology-Enabled Remote Hypertension Management To Advance Health Equity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 主要终点
- Difference in SBP change
研究概览
简要总结
The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.
详细描述
The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg. Participants will be subsequently monitored for up to 12 more months.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years - 100 years
- •uncontrolled hypertension: as defined as SBP > 140 or DBP > 90 on 2 successive clinic visits
排除标准
- •hearing impaired
- •visually impaired
- •cognitively impaired
- •hospice care
- •on hemodialysis at enrollment
- •New York Heart Association Class IV heart failure
研究组 & 干预措施
No intervention
Patients meeting inclusion care undergoing usual care in control clinics.
Technology-enabled blood pressure management
The intervention will consist of a technology-enabled remote hypertension management program. Participants will be given a cellular blood pressure (BP) cuff and patients with heart failure and chronic kidney disease stage 3b-5 will be given a scale also. Patients will undergo a series of protocolized software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg. Patients will be subsequently monitored for up to 12 more months. If their blood pressure increases, they can re-enter active management.
干预措施: Technology-enabled blood pressure management (Other)
结局指标
主要结局
Difference in SBP change
时间窗: 6 months after enrollment
Difference in mean change in systolic blood pressure (SBP)
次要结局
- Difference in DBP change(6 months after enrollment)
- HEDIS proportion(6 months after enrollment)