Community Support + MTM for Pregnancy-Induced Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized controlled trial will evaluate whether adding Community Health Worker (CHW)/Social Worker (SW)-led support for non-medical health related needs (NMHRN) and clinician-led Medication Therapy Management (MTM) to remote blood pressure monitoring improves outcomes for pregnant women with chronic hypertension or gestational hypertension (i.e high blood pressure that was present before pregnancy or developed during pregnancy).
All participants will monitor their blood pressure at home, use the TSU MH Rx app, and complete assessments related to social needs, depression, anxiety, pregnancy care experiences, and satisfaction. Only participants in the intervention group will receive targeted virtual social needs support and virtual regular MTM sessions focused on medications, self-care, adherence, and risk reduction. The study will assess blood pressure and maternal outcomes, feasibility, and participant satisfaction with the combined intervention.
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
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
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