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临床试验/NCT07606027
NCT07606027尚未招募不适用

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

University of Nebraska0 个研究点目标入组 404 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
404

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

申办方类型
Other
责任方
Sponsor

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