Community Health Worker Coaching to Reduce Cardiovascular Risk Among Women After a Hypertensive Disorder of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Care Group, Remote Blood Pressure Monitoring alone.
- Who it may be relevant to
- Registry conditions: Blood Pressure Monitoring, Hypertension (HTN), Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Community Health Worker Coaching to Reduce CVD Disease Risk Among Women After a Hypertensive Disorder of Pregnancy
Overview
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.
Detailed description
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.
Interventions
- Behavioral Enhanced Care Group
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 - Behavioral Remote Blood Pressure Monitoring alone
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
Primary outcome measures
- Rates of Blood Pressure Control [Time frame: 6 months]
- Change in mean systolic BP (mmHg), diastolic BP (mmHg), arterial pressure [Time frame: 6 months]
Secondary outcome measures (6)
- Weight change from delivery [Time frame: Weight change from delivery to 6 months postpartum]
- Change in intake of fiber, trans-fat, and fruit and vegetables [Time frame: 6 months]
- Change in physical activity [Time frame: 6 months]
- Change in the self-efficacy score in diet [Time frame: 6 months]
- Change in self-efficacy score in physical activity [Time frame: 6 months]
- Numbers of participants attending emergency department visits and being readmitted into hospitals [Time frame: From delivery to 6 months postpartum]
Eligibility criteria
Inclusion criteria
- 28 weeks gestation
- A current hypertensive disorders in pregnancy or chronic hypertension
- Singletons
- Access to phone
- Plan to deliver at Prisma Health-Midlands Hospital.
Exclusion criteria
- Multiples
- Fetal anomaly
- Don't speak English
- Already delivered a baby greater than 14 days ago.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of South Carolina — Columbia
Identifiers
NCT: NCT07457970 · 2362858-1 · 7355-SP