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

Sponsor: Texas Southern University • ClinicalTrials.gov ID: NCT07842341

Registry updated: 2026-10-14

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Description

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.

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

Eligibility criteria

Inclusion Criteria: * Female, pregnant ≤34 weeks * Pregnancy Status: Pregnant, up to 34 weeks of gestation. Able to provide medical confirmation of pregnancy * Age 18-45 * Diagnosis of chronic hypertension or Gestational Hypertension ( i.e: high blood pressure that was present before pregnancy or developed during pregnancy). * Currently taking ≥1 medication * Smartphone user * Able to speak and read English * Ability to participate in self-led surveys and perform remote blood pressure monitoring Exclusion Criteria: * Inability to Provide Legal Consent: Individuals who cannot legally consent to participate in the research study will be excluded. * Availability Constraints: Individuals who are unavailable or unable to commit to the required study sessions and self-led surveys throughout the duration of their pregnancy and the 14-week postpartum follow-up period. * Language Barrier: Individuals who do not speak and read English. * Inability or Unwillingness to Provide Required Information: Individuals who are unable or unwilling to provide reliable contact information (phone, email, or address for app/text-based study communications), basic medical history needed to verify eligibility, or medical confirmation of pregnancy and gestational age (e.g., discharge summary, progress note, MyChart note, or signed medical release).

Conditions

Hypertensive Disorders of Pregnancy Chronic Hypertension in Pregnancy Gestational Hypertension

Locations

Texas Southern University Nabrit Science Building, 3100 Cleburne St. — Houston, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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