About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
28 weeks gestation
A current hypertensive disorders in pregnancy or chronic hypertension
Singletons
Access to phone
Disqualifiers
Multiples
Fetal anomaly
Don't speak English
Already delivered a baby greater than 14 days ago.
Trial design
Parallel
Treatments tested in this trial
Enhanced Care Group
BehavioralDuring 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
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Rates of Blood Pressure Control
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
Arterial pressure will be calculated using formula ((SBP+2DBP)/3).
Secondary outcomes
Weight change from delivery
Weight change will be calculated by substracting weight at 6 months from the delivery room weight in pounds
Change in intake of fiber, trans-fat, and fruit and vegetables
the 19-item PrimeScreen, a brief validated dietary survey, will be used to assessed the change in dietary quality.
Change in physical activity
SenseWear Armbands will be used to objectively measure physical activity at baseline and at 6 months postpartum. Key physical activity measures will include the number of steps per day and mins/day spent in moderate-to-vigorous physical activity.
Change in the self-efficacy score in diet
Self-efficacy for overcoming common barriers to eating a healthy diet will be assessed using the Self-Efficacy for Diet Questionnaire (Sallis JF, 1988).
Sponsors and contacts
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University of South Carolina
Lead sponsor
Prisma Health-Midlands
Collaborator