158 Participants NeededMy employer runs this trial

Community Support + MTM for Pregnancy-Induced Hypertension

VA
MI
Overseen ByMark Ibarra-Garza, B.Sc, CCRP
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Texas Southern University
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 additional support from Community Health Workers and Social Workers, combined with specialized medication management, can improve outcomes for pregnant women with high blood pressure. Participants will monitor their blood pressure at home and receive support through an app. The trial includes two groups: one will receive the extra support and regular medication check-ins, while the other will continue with standard prenatal care. This trial suits pregnant women, up to 34 weeks, who have high blood pressure and are currently taking at least one medication.

As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance prenatal care for women with high blood pressure.

What prior data suggests that this protocol is safe for pregnant women with hypertension?

Research has shown that Medication Therapy Management (MTM) is generally easy for people to handle. MTM helps individuals manage their medications by ensuring they are safe, effective, and taken correctly. No specific reports of serious side effects from MTM itself have emerged.

Adding support from a Community Health Worker (CHW) or Social Worker (SW) to address non-medical health needs represents a newer approach. However, studies have demonstrated that using CHWs in healthcare is safe, offering benefits like improved health outcomes without major safety concerns. Overall, these methods aim to support patients and enhance their health without harmful side effects.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines personalized support with medication management in a way that's different from typical care for pregnancy-induced hypertension. Unlike standard treatments that focus mainly on medication, this approach adds a unique layer of virtual support from Community Health Workers and Social Workers to address non-medical health needs. Additionally, it includes remote blood pressure monitoring to better manage and adjust treatments. This holistic strategy aims to improve adherence to treatment plans and reduce risks for both mother and baby, making it a promising option to explore.

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

In this trial, participants in the experimental arm will receive a combination of Community Health Worker (CHW) and Social Worker (SW)-led non-medical health-related needs (NMHRN) intervention, along with Clinician-Led Medication Therapy Management (MTM) and remote blood pressure monitoring. Research has shown that involving CHWs and SWs can significantly aid in managing high blood pressure, as patients working with CHWs are more likely to maintain control over their blood pressure. Additionally, MTM ensures patients use their medications correctly and adhere to treatment plans, resulting in better health outcomes. Combining these methods with home blood pressure monitoring has proven effective in managing high blood pressure, particularly during pregnancy. These strategies aim to lower blood pressure and reduce risks for both the mother and baby. Participants in the control group will receive standard prenatal and postpartum care without these additional interventions.678910

Who Is on the Research Team?

MI

Mark Ibarra-Garza, B.Sc, CCRP

Principal Investigator

Texas Southern University

VA

Veronica Ajewole-Mwema, PharmD, BCOP

Principal Investigator

Texas Southern University

Are You a Good Fit for This Trial?

This trial is for pregnant women who have high blood pressure, either from before pregnancy or developed during pregnancy. Participants must be able to monitor their blood pressure at home and use a mobile app.

Inclusion Criteria

Able to speak and read English
Pregnancy status: pregnant up to 34 weeks of gestation with medical confirmation
Smartphone user
See 5 more

Exclusion Criteria

Unavailable or unable to commit to required study sessions and self-led surveys during pregnancy and 14-week postpartum follow-up
Do not speak and read English
I am unable or unwilling to share my contact or medical information as required.
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 remote blood pressure monitoring and complete assessments related to social needs, depression, anxiety, and pregnancy care experiences. Intervention group receives virtual CHW/SW-led support and MTM sessions.

Up to 54 weeks
Virtual sessions at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure and maternal outcomes, feasibility, and participant satisfaction.

10-14 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • Community Health Worker (CHW)/Social Worker (SW)-led non-medical health related needs (NMHRN) intervention + Clinician-Led Medication Therapy Management (MTM) with remote blood pressure monitoring

Trial Overview

The study compares usual care with an added program where community health workers or social workers help address non-medical needs, and clinicians provide medication management—all done virtually—alongside remote blood pressure monitoring.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM)Experimental Treatment1 Intervention
Group II: Active Comparator (Control group)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Southern University

Lead Sponsor

Trials
1
Recruited
350+

Health Resources and Services Administration (HRSA)

Collaborator

Trials
88
Recruited
152,000+

Citations

Community health worker‐led interventions for hypertension

CHW‐delivered health coaching can assist people with hypertension to understand the significance of blood pressure control and acquire essential self‐care ...

Hypertensive Disorders of Pregnancy: Innovative ...

We review the state of current management of HDP and innovative strategies such as blood pressure self-monitoring, telemedicine, and community ...

CHW/SW-led Support and Medication Therapy ...

This study aims to compare the change in mean systolic blood pressure between intervention and control groups in pregnant women with hypertension, with a ...

Approaches and outcomes of community health worker's ...

This review sought to critically assess the scope, content, and outcomes of CHW interventions designed to reduce blood pressure (BP) in low- and ...

Addressing Hypertension in Pregnancy to Reduce ...

ASTHO | Learn strategies to address hypertension in pregnancy and reduce maternal morbidity and mortality.

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