Feasibility of Remote Blood Pressure Monitoring to Improve Management of Hypertensive Disorders of Pregnancy (RBPM)
SH RBPM: Feasibility of Remote Blood Pressure Monitoring to Improve Management of Hypertensive Disorders of Pregnancy
This study represents an innovative approach to hypertensive disorders of pregnancy surveillance by using remote blood pressure monitoring to address the unique challenges of hypertensive disorders of pregnancy management in a predominantly rural state. Transitioning from episodic in-clinic monitoring to continuous, patient-centered monitoring changes how high-risk patients and healthcare providers detect hypertensive episodes and advances the field by establishing clinical effectiveness and feasibility of remote blood pressure monitoring (RBPM), to provide evidence for scaling interventions that improve maternal health.
研究概览
详细说明
This is a prospective study enrolling women who are pregnant or newly postpartum to monitor their blood pressures remotely. Additionally, a retrospective control group will serve as a comparison group that will have clinical data collected from the EMR on patients who had previous hypertensive disorders.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sophia Connelly, BA
- 电话号码：605-312-3332
- 邮箱：Sophia.Connelly@sanfordhealth.org
研究联系人备份
- 姓名：Andrew Williams, PhD, MD
- 电话号码：701-777-6718
- 邮箱：Andrew.D.Williams@und.edu
学习地点
-
-
North Dakota
-
Fargo、North Dakota、美国、58104
- Sanford Health
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接触：
- Sophia Connelly, BA
- 电话号码：605-312-3332
- 邮箱：Sophia.Connelly@sanfordhealth.org
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接触：
- Peter VanEerden, MD
- 电话号码：(701) 234-3443
- 邮箱：Peter.VanEerden@sanfordhealth.org
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首席研究员：
- Peter VanEerden, MD
-
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women aged 18 years or older
- Either currently pregnant or within 10 days postpartum
- Singleton pregnancy
- Diagnosed with a hypertensive disorder during the current or the most recent pregnancy
- Able and willing to provide informed consent
Exclusion Criteria:
- Men will not be included in the study
- Women younger than 18 years of age
- Women with a multiple gestation pregnancy
- Those without a hypertensive disorder of pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Remote Monitoring Arm
Pregnant or newly postpartum women who are diagnosed with a hypertensive disorder of pregnancy and consent to monitor their blood pressures remotely. |
Participants will take their blood pressure at least twice daily until cleared by their OB, typically at their 6 week post-partum visit. Every time a participant takes their blood pressure, the cuffs will track the blood pressure and allow the participants to review previous blood pressures and document them for their provider. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Remote Blood Pressure Monitoring Adherence using the Homedics 700 Series Arm Blood Pressure Monitor or Equivalent for Women with Hypertensive Disorders of Pregnancy.
大体时间：Enrollment to 6 week post partum visit
|
Study will determine whether RBPM improves adherence to recommended blood pressure monitoring protocols compared to in clinic monitoring. The study will utilize the Homedics 700 Series Arm Blood Pressure Monitor or equivalent. The monitor will be provided to participants who will be asked to monitor and record their blood pressures at home twice daily (or more if they would like). |
Enrollment to 6 week post partum visit
|
|
Provider and Patient Satisfaction by surveying participants on their experience with remote blood pressure monitoring.
大体时间：Enrollment to 6 week post partum visit
|
Both participants and participant's primary OB provider will be surveyed on their satisfaction with RBPM. |
Enrollment to 6 week post partum visit
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The coded RBPM, EMR derived analytic datasets, and survey files will be stored on an access controlled UND servers, which meets NIH requirements for long term preservation and security. The combined and coded data will be shared with the ICPSR. This is a repository through the University of Michigan. The repository will make this data restricted from the public for the first 3 years, and users would need to request permission and a project proposal to access the data.
IPD 共享时间框架
Data will be made available upon approval and publication of any manuscripts.
IPD 共享访问标准
Users would need to request permission and a project proposal to access the data.
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