240 Participants NeededMy employer runs this trial

Community Health Worker Coaching for Hypertension After Pregnancy

(HERHEART Trial)

JL
AM
Overseen ByAndrew Mather, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Enhanced Care Group program helps women who experienced high blood pressure during pregnancy better manage their health. The program combines remote blood pressure monitoring with support from a community health worker to improve heart health, enhance mental well-being, and reduce hospital visits. Women who are around 28 weeks pregnant, have high blood pressure, and plan to deliver at Prisma Health-Midlands Hospital might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative healthcare solutions that could benefit future mothers.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced program is safe for women with hypertension after pregnancy?

Research has shown that community health workers (CHWs) effectively support women after pregnancy and are generally well-received. In studies on postpartum care, CHWs improve patient satisfaction and information levels. They assist with blood pressure monitoring, crucial for women who experienced high blood pressure during pregnancy. One study found this method practical and promising for safely aiding women after childbirth.

The enhanced care program includes home blood pressure monitoring and lifestyle support from CHWs. This approach has been tested in similar situations and has yielded good results without major safety issues. By focusing on lifestyle changes and monitoring instead of medication, it is less likely to cause side effects. Overall, the emphasis on education and support from trained health workers makes this approach a safe option based on current evidence.12345

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker Coaching for Hypertension After Pregnancy because it combines remote blood pressure monitoring with a community health worker (CHW)-led lifestyle program. Unlike traditional treatments that often rely solely on medication to manage blood pressure, this approach emphasizes personalized coaching and lifestyle changes, which can be more sustainable and empowering for new mothers. By integrating technology with human support, this method aims to improve long-term health outcomes and reduce the risk of future cardiovascular issues.

What evidence suggests that this trial's treatments could be effective for hypertension after pregnancy?

Research has shown that a new program, which combines home blood pressure monitoring with a lifestyle program led by a community health worker, may help women manage high blood pressure after pregnancy. In this trial, participants in the Enhanced Care Group will receive this combined approach. Early results from a study with the first 30 participants showed that their systolic blood pressure dropped by an average of 8.03 mmHg from the start to the follow-up. Community health workers can also enhance understanding and satisfaction with blood pressure monitoring. This suggests that including a community health worker on the care team could improve blood pressure control and heart health for women after giving birth.23467

Are You a Good Fit for This Trial?

This trial is for women who are at least 28 weeks pregnant with a single baby, have high blood pressure during pregnancy or chronic hypertension, can use a phone, and plan to deliver at Prisma Health-Midlands Hospital.

Inclusion Criteria

* 28 weeks gestation
* Singletons
* Access to phone
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote blood pressure monitoring and lifestyle coaching for 6 weeks postpartum

6 weeks
Daily BP monitoring for 2 weeks, 3-5 times per week for weeks 3-6

Extended Monitoring

Continued BP monitoring for participants with high BP or on medication, and weekly health coaching for 10 weeks

6 months
3 times per week BP monitoring, 10 weekly coaching calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Care Group

Trial Overview

The study compares two groups: one uses remote blood pressure monitoring alone; the other gets this plus coaching from a community health worker on healthy lifestyle habits. The goal is to see which approach better improves heart health after pregnancy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Care GroupExperimental Treatment1 Intervention
Group II: Remote Blood Pressure Monitoring aloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials
233
Recruited
122,000+

Prisma Health-Midlands

Collaborator

Trials
24
Recruited
2,800+

Citations

Study Details | NCT07457970 | Community Health Worker ...

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 ...

ENHANCED SUPPORT FOR WOMEN WITH ...

Preliminary results show from the first 30 participants show a significant decline in BP from enrollment to follow up {SBP: -8.03 ± 15.34 mmHg ( ...

Early Outcomes of an Extended Postpartum Hypertension ...

Hypertensive disorders of pregnancy affect up to 20% of pregnant individuals and significantly increase long-term cardiovascular disease (CVD).

The Impact of Community Health Workers in a Pre-existing ...

This study evaluated whether community health workers (CHWs) improve education, satisfaction, and blood pressure monitoring in postpartum patients with HDP.

Advances in postpartum hypertension management

Postpartum hypertension care clinic visits within 6–12 weeks postpartum should include a BP check, education about lifestyle changes, and ...

Community Health Worker Coaching for Hypertension After ...

The goal of this clinical trial is to find out whether an enhanced program works better than remote blood pressure monitoring (RBPM) alone ...

ETD | ID: vh53ww96h | Emory Theses and Dissertations

An Enhanced Community Health Worker Support Program for Postpartum women with Hypertensive Disorders of Pregnancy at Grady Memorial Hospital ...