Community Support + MTM for Pregnancy-Induced Hypertension
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.12345Why 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?
Mark Ibarra-Garza, B.Sc, CCRP
Principal Investigator
Texas Southern University
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood pressure and maternal outcomes, feasibility, and participant satisfaction.
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
Subjects in the experimental arm (intervention group) will receive virtual Clinician-Led Medication Therapy Management (MTM) at randomization (weeks 0-2) and then every 4 weeks (±14 days) until 14 weeks postpartum. MTM includes medication reconciliation, assessment, maternal self-care education, review of labs, dosing recommendations, and guidance to improve adherence and reduce adverse maternal/neonatal outcomes. They will also receive virtual CHW/SW-led targeted non-medical health related needs (NMHRN) support at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum. All participants in the intervention arm will receive CHW/SW check-ins at each of these three points; those without identified social needs will receive general check-ins rather than targeted interventions.
Participants randomized to Active comparator arm (Control group) will receive standard prenatal and postpartum care as provided by their healthcare providers. Participants will not receive the Community Health Worker/Social Worker-led non-medical health-related needs intervention, or the clinician-led Medication Therapy Management through the study. Study assessments and outcome data will be collected according to the study schedule.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Texas Southern University
Lead Sponsor
Health Resources and Services Administration (HRSA)
Collaborator
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 ...
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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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