Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Participant Survey
研究概览
简要总结
The primary objective of this study is to assess the feasibility and effectiveness of a mobile-technology based system that integrates patient-facing and clinician-facing components to assist the management of hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •18 years or older with an established diagnosis of essential hypertension
排除标准
- •Patients on more than 2 antihypertensives at time of enrollment
- •Clinical diagnosis of secondary hypertension, that is, hypertension due to a secondary cause, including but not limited to the following:
- •Renal artery stenosis
- •Primary hyperaldosteronism
- •Cushing syndrome
- •Coarctation of the aorta
- •Drug-induced hypertension
- •Pheochromocytoma
- •Obstructive sleep apnea
- •Hospitalization for malignant hypertension or severe hypertension (including stroke, cardiac events, acute kidney injury) in the preceding 6 months
- •Hospitalization for unstable angina or myocardial infarction in the preceding 6 months
- •Prior diagnosis of heart failure or cardiomyopathy
- •Stroke or transient ischemic attack within prior 6 months
- •Prior organ transplantation
- •Failure to obtain informed consent
- •Pregnant or currently trying to become pregnant
- •Patients who are enrolled in other research studies
研究组 & 干预措施
Single-arm: Blood pressure intervention
Participants will use a mobile technology system comprising of a remote home blood pressure monitoring cuff and a mobile application integrated with a clinician-facing component to view and manage remote blood pressures. Participants will use this for 12 weeks, with assessment of blood pressure outcomes and anonymous surveys regarding the technology at 12 weeks.
干预措施: Mobile technology intervention (Combination Product)
结局指标
主要结局
Participant Survey
时间窗: 12 weeks
A survey regarding usability and feedback about the intervention completed by participants. Questions 1 through 5 were rated on a scale of 1 (strongly disagree) to 7 (strongly agree); question 6 was rated on a scale of 1 (extremely confident) to 5 (extremely doubtful).
Physician Survey
时间窗: 12 weeks
A survey regarding usability and feedback about the intervention completed by physicians. Physicians provided survey responses, but were not enrolled in the study. Questions 1, 2, and 3 were rated on a scale of 1 (strongly agree) to 7 (strongly disagree); question 4 was rated on a scale of 1 (extremely confident) to 5 (extremely doubtful); question 5 was rated on a scale of 1 (extremely pleased) to 7 (extremely displeased).
Change in Blood Pressure
时间窗: Assessed at baseline and week 12
Change in systolic and diastolic blood pressure (SBP and DBP).
次要结局
未报告次要终点
研究者
Paul Wang
Professor of Medicine
Stanford University