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.
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).
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).
Parallel
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
BehavioralSubjects 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)
BehavioralSubjects 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
Change in mean systolic blood pressure
The primary clinical endpoint is the change in mean Systolic Blood Pressure (SBP) compared between the intervention and control groups. To be eligible in the primary analysis, participants must contribute to a minimum of 3 weeks of blood pressure data.
Recruitment rates
Measures feasibility by assessing how efficiently eligible participants are recruited into the study. Recruitment performance helps determine scalability of the intervention.
Retention Rate
Evaluates participant retention and continued engagement through the full study period, including remote BP monitoring and scheduled intervention or control assessments. Retention is used as a key feasibility indicator.
Technical Reliability of the 4G Blood Pressure Monitoring Device, TSU MH-Rx App, and Text Alerts
Technical reliability will be assessed using (1) participant ratings on four questions (items 19-22) of the MH-Rx Patient Satisfaction Survey, rated on a 5-point scale (1 = strongly disagree, 5 = strongly agree) covering device setup and use, cellular connection reliability, confidence that readings were transmitted, and battery/charging convenience, reported as the mean subscale score ranging from 1 to 5, where higher scores mean better perceived reliability; and (2) the total number of participant technical support tickets logged in the study's technical support-tracking system (JIRA), reported overall and by category (e.g., BP reading not transmitted or not displayed, device connectivity, app access or login, text/app alert delivery, and other troubleshooting).
Participant Satisfaction with study participation
Participant satisfaction with overall study participation will be assessed using a standardized (non-validated) satisfaction survey. The survey will evaluate participants' perceptions of the study procedures, remote blood pressure monitoring, TSU MH Rx app, study communications, assessments, and overall study experience. For participants in the intervention arm, satisfaction with the Community Health Worker/Social Worker-led social needs intervention sessions and clinician-led Medication Therapy Management sessions will also be assessed from eight questions (items 11-18) of the survey. All survey questions are rated on a 5-point scale (1 = strongly disagree, 5 = strongly agree). Reported as a single combined mean score, ranging from 1 to 5, where higher scores mean greater satisfaction.
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Texas Southern University
Lead sponsor
Health Resources and Services Administration (HRSA)
Collaborator
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