174 Participants NeededMy employer runs this trial

Community Health Worker Support for Postpartum Hypertension

(AW2H Trial)

JR
Overseen ByJesse Rattan, PhD, MPH, RN
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
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 pairing new mothers with a community health worker (CHW) can help lower blood pressure after pregnancy. High blood pressure during or after pregnancy, such as preeclampsia or gestational hypertension, increases the risk of heart disease later. Participants will receive a home blood pressure monitor and education on its use. Those in the CHW group will receive additional support, including help with medications and heart-healthy habits. Ideal candidates are new mothers who experienced high blood pressure related to their pregnancy and gave birth at the University of Alabama at Birmingham (UAB) Hospital. As an unphased trial, this study provides a unique opportunity for participants to contribute to valuable research that could enhance postpartum care for future mothers.

What prior data suggests that the Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program is safe?

Studies have shown that using community health workers (CHWs) to support patients is safe and well-received. Research indicates that these programs focus on education, guidance, and emotional support, which are generally low-risk activities. Reports of negative effects are rare because these programs do not involve medication or medical procedures.

In the Alabama Womb to Heart Solution (AW2H) trial, trained CHWs work with new mothers who have high blood pressure for six months. The program helps manage blood pressure through coaching and education. By focusing on non-medical support like home blood pressure checks, promoting healthy habits, and offering emotional support, it remains safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program because it offers a personalized approach to managing postpartum hypertension. Unlike standard treatments, which typically involve medication and education on self-monitoring blood pressure, this program incorporates the ongoing support of community health workers for six months. This hands-on support aims to improve health outcomes by providing continuous education and encouragement, potentially making it easier for new mothers to manage their blood pressure effectively. This approach could lead to better long-term cardiovascular health for postpartum women.

What evidence suggests that the Alabama Womb to Heart Solution (AW2H) Community Health Worker Program is effective for postpartum hypertension?

Research shows that using telehealth at home to monitor blood pressure after childbirth can reduce the likelihood of hospital readmission compared to regular care. Studies have found that community health workers (CHWs) improve adherence to health advice. Participants in similar programs tend to remain engaged, continuing with the program. In this trial, one group will receive usual care, while another group will receive usual care plus the Alabama Womb to Heart Solution (AW2H). This solution employs CHWs to help mothers monitor their blood pressure, take medications, and adopt heart-healthy habits. This method relies on evidence that personalized support and monitoring can effectively manage high blood pressure after childbirth.678910

Who Is on the Research Team?

JR

Jesse Rattan, PhD, MPH, RN

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 16-56 who delivered at UAB Hospital in the last six weeks (including pregnancy loss) and had high blood pressure during or after pregnancy. They must not be incarcerated, already in similar studies, or unwilling to be randomly assigned.

Inclusion Criteria

Speaks and writes in English
I am between 16 and 56 years old.
Delivered in the last six weeks at >=14 weeks gestational age, including pregnancy loss
See 2 more

Exclusion Criteria

Does not speak English
Currently incarcerated
Currently enrolled in other community health worker studies or services
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or usual care plus the AW2H CHW program for 6 months

6 months
Visits or contacts approximately 2 times per week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26 (in person or virtual)

Follow-up

Participants are monitored for systolic and diastolic blood pressure, and integration into primary care is assessed

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Alabama Womb to Heart Solution (AW2H) Community Health Worker (CHW) Program

Trial Overview

The study compares usual postpartum care with self-blood pressure monitoring versus the same care plus regular support from a trained community health worker for six months. Participants are randomly placed into one of these two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Usual Care + Alabama Womb to Heart Solution (AW2H) Community Health Worker ProgramExperimental Treatment2 Interventions
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

ConnectionHealth

Collaborator

Trials
2
Recruited
440+

Preeclampsia Foundation

Collaborator

Trials
4
Recruited
50,900+

Citations

(PDF) Postpartum cardio-obstetrics rehabilitation program ...

Six of 20 screened participants (30% recruitment) completed the intervention (100% retention). Overall adherence to scheduled sessions was 71%.

(PDF) Advances in postpartum hypertension management

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Clinical Outcomes Associated With a Remote Postpartum ...

Outcomes included postpartum readmission, office visit within 6 weeks postpartum, BP measurement within 10 days, and initiation of ...

Maternal and Child Health Resource Repository

Penn Medicine uses digital technology to help postpartum women take control of their blood pressure. Leveraging Technology, Maternal Health.

P³OPPY Project

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