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临床试验/NCT07457970
NCT07457970招募中不适用

Community Health Worker Coaching to Reduce CVD Disease Risk Among Women After a Hypertensive Disorder of Pregnancy

University of South Carolina1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年4月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
Rates of Blood Pressure Control

研究概览

简要总结

The goal of this clinical trial is to find out whether an enhanced program works better than remote blood pressure monitoring (RBPM) alone for women who had high blood pressure during pregnancy. The enhanced program combines RBPM with a lifestyle program led by a community health worker (CHW).

The study will examine whether the enhanced program helps women better control their blood pressure, lowers their average resting blood pressure, improves heart health risk factors (such as weight, diet, physical activity), supports mental well-being, and reduces emergency department visits and hospital readmissions by 6 months after delivery.

详细描述

The investigators will enroll 240 eligible pregnant women between 28 weeks gestation until the delivery. All participants will have a current or past history of high blood pressure during pregnancy, chronic high blood pressure, and a single-baby pregnancy.

RBPM alone program:

Participants in this group will receive an automatic blood pressure (BP) cuff and wear the cuff for 6 weeks after childbirth. Participants will be asked to measure their BP every day during the first 2 weeks after delivery and 3-5 times per week during weeks 3-6. BP readings will be sent automatically to the electronic medical record. A clinical decision support system will identify missing readings or possible care needs. A nurse will send reminders, contact participants to discuss symptoms or medications, and refer them to their primary care providers when needed. At 7 weeks after delivery, BP monitoring and text messages will stop, and BP cuffs will be collected. After the initial 6 weeks after delivery, participants in the RBPM-only group will receive weekly messages with publicly available information about heart disease risk after high blood pressure in pregnancy, healthy lifestyle tips from professional organizations, and guidance on infant development.

Enhanced Care program During the first 6 weeks after delivery, participants in the enhanced care group will receive the same RBPM program described above. Starting at 7 weeks after delivery, women whose BP was normal during the first 6 weeks will stop BP monitoring. Women whose BP remains high (above 130/80 mmHg) or who are still taking BP medications will continue monitoring their BP three times per week until 6 months after delivery. Nurses will continue to provide reminders and support.

In addition, participants in the enhanced care group will receive 10-week health coaching led by a community health worker (CHW). This will include 10 weekly coaching calls by CHW. The coaching will focus on heart-healthy lifestyle behaviors that help lower BP and improve heart health. These include healthy weight loss goals (1-3 pounds per week), better nutrition, gradually increasing physical activity, stress management, and quitting tobacco use. Participants will be reminded to watch the weekly videos (~30 min long). The CHW will screen for social needs (such as food, housing, or transportation) and connect participants to available community services. Participants will receive a personalized weight-tracking graph.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 28 weeks gestation
  • A current hypertensive disorders in pregnancy or chronic hypertension
  • Singletons
  • Access to phone
  • Plan to deliver at Prisma Health-Midlands Hospital.

排除标准

  • Multiples
  • Fetal anomaly
  • Don't speak English
  • Already delivered a baby greater than 14 days ago.

研究组 & 干预措施

Enhanced Care Group

Experimental

Remote blood pressure monitoring and CHW-led lifestyle program

干预措施: Enhanced Care Group (Behavioral)

Remote Blood Pressure Monitoring alone

Active Comparator

Remote BP monitoring alone

干预措施: Remote Blood Pressure Monitoring alone (Behavioral)

结局指标

主要结局

Rates of Blood Pressure Control

时间窗: 6 months

Percentage of participants with controlled blood pressure (\<130/80 mmHg). Blood pressure will be measured three times for each participant, with 60 seconds rest between each measurement using Omron HEM-780 automated monitor. The average of three measures will be used for each visit.

Change in mean systolic BP (mmHg), diastolic BP (mmHg), arterial pressure

时间窗: 6 months

Arterial pressure will be calculated using formula ((SBP+2DBP)/3).

次要结局

  • Weight change from delivery(Weight change from delivery to 6 months postpartum)
  • Change in intake of fiber, trans-fat, and fruit and vegetables(6 months)
  • Change in physical activity(6 months)
  • Change in the self-efficacy score in diet(6 months)
  • Change in self-efficacy score in physical activity(6 months)
  • Numbers of participants attending emergency department visits and being readmitted into hospitals(From delivery to 6 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jihong Liu

Professor

University of South Carolina

研究点 (1)

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