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Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)

2026年5月19日 更新者:University of Nebraska

Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure

The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.

研究概览

研究类型

介入性

注册 (估计的)

404

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

  • 姓名:Sajid Shahul, MD, PhD
  • 电话号码:773-398-2956
  • 邮箱:sshahul@unmc.edu

研究联系人备份

  • 姓名:Mridula Ghotane, MPH
  • 电话号码:445-260-9532
  • 邮箱:mghotane@unmc.edu

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

接受健康志愿者

不

描述

Inclusion Criteria:

  • Black/ African American patients
  • Age: 19 and 50 years of age
  • Diagnosis: Hypertension Disorders of Pregnancy
  • Enrolled in STAMPP-HTN for first 6 weeks postpartum

Exclusion Criteria:

  • Age: <19 years
  • Significant Kidney or Liver disease that may limit antihypertensive medication adjustment

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:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Collaborative Care Intervention
Participants assigned to this arm will receive a collaborative care intervention that includes home blood pressure monitoring using a provided device and support from community health workers. The intervention includes education on hypertension management, assistance with care coordination, and support with healthcare navigation. Participants will regularly measure blood pressure and receive ongoing guidance throughout the 12-month postpartum follow-up period.
Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support. CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health. Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.
有源比较器:Standard Postpartum Care
Participants assigned to this arm will receive standard postpartum care. In addition, participants will be provided with a home blood pressure monitoring device and instructed to measure their blood pressure regularly. No additional community health worker support will be provided.
Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration. Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.

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
Blood Pressure Control (BP <130/80 mmHg)
大体时间:Baseline (6 weeks) postpartum to 12 months postpartum
Primary endpoint - The proportion of patients achieving a target blood pressure of less than 130/80 mmHg. Blood pressure will be analyzed both as a dichotomous variable (normal <130/80 mmHg vs. elevated) and as a continuous variable (mean systolic and diastolic readings).
Baseline (6 weeks) postpartum to 12 months postpartum

次要结果测量

结果测量
措施说明
大体时间
Patient Activation Measure (PAM-13)
大体时间:At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Evaluation of survey-based mechanisms of action to determine if they mediate the impact of the Collaborative Care intervention on blood pressure outcome. It assesses patient engagement and activation. A 13-item survey instrument with scores ranging from a minimum of 0 to a maximum of 100. Higher scores indicate a better outcome (greater patient engagement and activation).
At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Morisky Medication Adherence Scale (MMAS-8)
大体时间:At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
A survey-based mechanism of action evaluated via an 8-item self-report survey scale to determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. It measures medication adherence behavior. Scores range from a minimum of 0 to a maximum of 8, where higher scores indicate a better outcome (higher medication adherence). Scores are categorized into low (<6), medium (6 to <8), and high (8) adherence.
At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Trust in Physician Scale
大体时间:At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
An 11-item exploratory survey instrument used to evaluate trust in the health care system and determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. Scores range from a minimum of 11 to a maximum of 55, where higher scores indicate a better outcome (greater trust in the healthcare provider).
At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Severe Maternal Morbidity (SMM) Composite Rate
大体时间:Baseline (6weeks) postpartum to 12 months (1 year) postpartum
Composite Endpoint - Incidence rates of severe maternal morbidity events to assess the efficacy of the Collaborative Care model in reducing overall maternal risk. This composite variable tracks the occurrence of any unplanned emergency department (ED) visit, unplanned hospitalization, or the presence of a severe morbidity event. Severe morbidity events are strictly defined as the clinical occurrence of severe hypertension, acute heart failure, pulmonary edema, eclampsia, acute renal failure, shock, sepsis, cardiac arrest, arrhythmias, myocardial infarction, pulmonary embolism, stroke, or death.
Baseline (6weeks) postpartum to 12 months (1 year) postpartum

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。

调查人员

  • 首席研究员:Sajid Shahul, MD, PhD、Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (估计的)

2026年7月1日

初级完成 (估计的)

2031年6月30日

研究完成 (估计的)

2031年6月30日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年5月26日

上次提交的符合 QC 标准的更新

2026年5月19日

最后验证

2026年5月1日

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)?

不

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

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