Blood Pressure MonitoringHERHEARTNCT07457970
Community Health Worker Coaching to Reduce Cardiovascular Risk Among Women After a Hypertensive Disorder of Pregnancy
A study testing Enhanced Care Group and Remote Blood Pressure Monitoring alone in people with Blood Pressure Monitoring and Hypertension (HTN), run by University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Blood Pressure Monitoring, Hypertension (HTN), Pregnancy
- What is being tested?
- Enhanced Care Group and Remote Blood Pressure Monitoring alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to 15 Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 28 weeks gestation
- A current hypertensive disorders in pregnancy or chronic hypertension
- Singletons
- Access to phone
- Plan to deliver at Prisma Health-Midlands Hospital.
Who cannot join
- Multiples
- Fetal anomaly
- Don't speak English
- Already delivered a baby greater than 14 days ago.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Jihong Liu, ScD, 8037776854, jliu@mailbox.sc.edu
Andrew Mather, MD
About this study
Official title: Community Health Worker Coaching to Reduce CVD Disease Risk Among Women After a Hypertensive Disorder of Pregnancy
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.
Read the 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.
- Conditions
- Blood Pressure Monitoring, Hypertension (HTN), Pregnancy
- Being tested
- Enhanced Care Group, Remote Blood Pressure Monitoring alone
- Keywords
- community health worker, lifestyle intervention, Blood pressure monitoring, postpartum, Cardiovascular risk
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Care GroupBehavioural
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 aloneBehavioural
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 group | Role | What they receive |
|---|---|---|
| Enhanced Care Group | Experimental | Remote blood pressure monitoring and CHW-led lifestyle program Receives: Behavioral: Enhanced Care Group |
| Remote Blood Pressure Monitoring alone | Active comparator | Remote BP monitoring alone Receives: Behavioral: Remote Blood Pressure Monitoring alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Change in mean systolic BP (mmHg), diastolic BP (mmHg), arterial pressure
Arterial pressure will be calculated using formula ((SBP+2DBP)/3).
Measured: 6 months
Secondary outcomes (6)
Weight change from delivery
Weight change will be calculated by substracting weight at 6 months from the delivery room weight in pounds
Measured: Weight change from delivery to 6 months postpartum
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Change in self-efficacy score in physical activity
Self-efficacy for overcoming common barriers to exercise will be assessed using a validated 5-item questionnaire (Marcus BH, 1992).
Measured: 6 months
Numbers of participants attending emergency department visits and being readmitted into hospitals
ED visits and hospital readmissions from delivery room until 6 months postpartum will be abstracted from medical records. Changes in total ED visits and hospital readmissions will be calculated.
Measured: From delivery to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start24 Apr 2026
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Midlands
- Responsible party
- Principal investigator, Jihong Liu, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457970
- Sponsor's protocol ID
- 2362858-1
- Other IDs
- 7355-SP
- Acronym
- HERHEART
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including baseline characteristics, outcome measures) that underlie the results reported in publications will be shared. The study protocol, statistical analysis plan, and data dictionary will also be made available.