Community Health Worker Coaching to Reduce CVD Disease Risk Among Women After a Hypertensive Disorder of Pregnancy
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of South Carolina
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Rates of Blood Pressure Control
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Enhanced Care Group
Remote blood pressure monitoring and CHW-led lifestyle program
Intervention: Enhanced Care Group (Behavioral)
Remote Blood Pressure Monitoring alone
Remote BP monitoring alone
Intervention: Remote Blood Pressure Monitoring alone (Behavioral)
Outcomes
Primary Outcomes
Rates of Blood Pressure Control
Time Frame: 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
Time Frame: 6 months
Arterial pressure will be calculated using formula ((SBP+2DBP)/3).
Secondary Outcomes
- 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)
Investigators
Jihong Liu
Professor
University of South Carolina