此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Mobile Health Program for Post-Preeclampsia Hypertension

2026年7月27日 更新者：Malamo Countouris、University of Pittsburgh

Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • 招聘中
        • UPMC Magee Womens Hospital
        • 接触：
        • 接触：
        • 首席研究员：
          • Malamo Countouris, MD, MS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.
  • Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).

Exclusion Criteria:

  • Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).
  • Males will also be excluded from this study as it focuses on pregnancy related conditions.
  • Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 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：Coaching Application + HBPM
A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring and provide guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control. The application is connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 3-month intervention duration and a Bluetooth blood pressure cuff.
行为的：辅导申请
为家庭血压监测提供教育和支持的数字应用程序。
行为的：居家血压监测
用于在家中测量血压的设备，具有用于自动收集的蓝牙连接。
有源比较器：Enhanced usual care with WebMD
Enhanced usual care participants will receive a smartphone for the 3-month intervention duration and the wireless Bluetooth blood pressure cuff. Through this, enhanced usual care participants will have access to WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants will also receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform.
行为的：居家血压监测
用于在家中测量血压的设备，具有用于自动收集的蓝牙连接。
其他：网络医学博士
基于智能手机的健康教育和/或监测应用程序。

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
Change in systolic blood pressure from baseline to 3 months
大体时间：Baseline, 3 Months
Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.
Baseline, 3 Months

次要结果测量

结果测量
措施说明
大体时间
Change in diastolic BP and mean arterial pressure from baseline to 3 months
大体时间：Baseline, 3 months
Change in diastolic BP and mean arterial pressure from baseline to 3 months
Baseline, 3 months
Adherence to antihypertensive medications at 3 months and 6 months
大体时间：Baseline, 6 months
Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.
Baseline, 6 months
Proportion with BP controlled <130/80 mmHg at 3 months and 6 months
大体时间：Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Adherence to home blood pressure monitoring
大体时间：Baseline, 3 months
Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence.
Baseline, 3 months
Feasibility of study measured using enrollment, survey completion, and retention of participants
大体时间：Baseline, 3 Month, 6 Month
Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study
Baseline, 3 Month, 6 Month
Durable change in systolic blood pressure measures at 6 months
大体时间：Baseline, 6 months
Durable change in SBP measures at 6 months between intervention and usual care arms
Baseline, 6 months
Durable change in diastolic BP measures at 6 months
大体时间：Baseline, 6 months
Durable change in DBP measures at 6 months between intervention and usual care arms
Baseline, 6 months
Blood pressure at 3 months
大体时间：Baseline, 3 months
Systolic, diastolic, and mean arterial blood pressure at 3 months
Baseline, 3 months
Blood pressure at 6 months
大体时间：Baseline, 6 months
Systolic, diastolic, and mean arterial blood pressure at 6 months
Baseline, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Pittsburgh

合作者

McKamish Family Foundation

调查人员

  • 首席研究员：Malamo Countouris, MD, MS、University of Pittsburgh

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月22日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY25070197

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The study team will share all of the individual participant data collected during the trial, after deidentification.

IPD 共享时间框架

The data will be available 12 months following publication of the primary results of this trial.

IPD 共享访问标准

Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator at countourisme@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be provided directly by the study investigators. Costs associated with producing datasets and analysis will be the responsibility of investigators seeking the data.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅