MH-Rx Study (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)

Part of paid clinical trials in Houston, Texas.

Sponsor
Texas Southern University
Study ID
NCT07842341
Status
Recruiting
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Conditions

  • Chronic Hypertension in Pregnancy
  • Gestational Hypertension
  • Hypertensive Disorders of Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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 — BEHAVIORAL
    Subjects in the experimental arm (intervention group) will receive a TelliHealth BP01 remote blood pressure monitoring kit and access to the TSU MH Rx app. They will complete self-led BP checks at least three times weekly until 14 weeks postpartum, with automated text/app alerts for abnormal readings. They will also complete self-administered assessments at specified time points: the modified PREPARE NMHRN survey, PHQ-9 depression survey, and GAD-7 anxiety survey at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum; the PCPC-US prenatal experience survey at 32-36 weeks; and the PCMC-US intrapartum experience and participant satisfaction surveys at 10-14 weeks postpartum. Abnormal NMHRN, PHQ-9, and GAD-7 results will trigger electronic alerts and appropriate resources, while GAD-7 and PHQ-9 scores will be reviewed using a tiered management plan. Any PHQ-9 question 9 (suicidal ideation) score ≥1 will prompt same-business-day contact, provision of 988 Suicide and Crisis
  • Active Comparator (Control group) — BEHAVIORAL
    Subjects in the Active comparator arm (control group) will receive a TelliHealth BP01 remote blood pressure monitoring kit and access to the TSU MH Rx app. They will complete self-led BP checks at least three times weekly until 14 weeks postpartum, with automated text/app alerts for abnormal readings. They will also complete self-administered assessments at specified time points: the modified PREPARE NMHRN survey, PHQ-9 depression survey, and GAD-7 anxiety survey at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum; the PCPC-US prenatal experience survey at 32-36 weeks; and the PCMC-US intrapartum experience and participant satisfaction surveys at 10-14 weeks postpartum. Abnormal NMHRN, PHQ-9, and GAD-7 results will trigger electronic alerts and appropriate resources, while GAD-7 and PHQ-9 scores will be reviewed using a tiered management plan. Any PHQ-9 question 9 (suicidal ideation) score ≥1 will prompt same-business-day contact, provision of 988 Suicide and Crisis

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Sep 25, 2026
Status verified
Oct 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM)
    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.
  • Active Comparator: Active Comparator (Control group)
    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.

Primary Outcome Measure

Change in mean systolic blood pressure [ Time Frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Southern University Nabrit Science Building, 3100 Cleburne St.HoustonTexas77004
Veronica Ajewole-Mwema, PharmD, BCOP
[email protected]
713-313-1217
Mark Ibarra-Garza, B.Sc, CCRP
[email protected]
713-313-4349

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By research site
Texas Southern University Nabrit Science Building, 3100 Cleburne St.· Houston, TX

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