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

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT07457970
Status
Recruiting
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Conditions

  • Blood Pressure Monitoring
  • Hypertension (HTN)
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Care Group — BEHAVIORAL
    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 v
  • Remote Blood Pressure Monitoring alone — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 24, 2026
Status verified
Apr 2026
Primary completion
Jul 15, 2029
Completion
Jul 15, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Enhanced Care Group
    Remote blood pressure monitoring and CHW-led lifestyle program
  • Active Comparator: Remote Blood Pressure Monitoring alone
    Remote BP monitoring alone

Primary Outcome Measure

Rates of Blood Pressure Control [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South CarolinaColumbiaSouth Carolina29208
Jihong Liu, ScD
[email protected]
8037776854
Andrew Mather, MD (SUB_INVESTIGATOR)

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By research site
University of South Carolina· Columbia, SC

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