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NCT Number: NCT07842341

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

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.

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Key information

Conditions

Hypertensive Disorders of Pregnancy Cardiovascular Diseases Chronic Hypertension in Pregnancy Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Southern University Nabrit Science Building, 3100 Cleburne St.

Houston, Texas, 77004, United States

About this study

This randomized controlled trial will evaluate the effectiveness of combining 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 (BP) monitoring among 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 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. All participants 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 Lifeline information, and recommendation for immediate PCP/OBGYN follow-up.

Only intervention-arm subjects will receive virtual CHW/SW-led tailored social needs support sessions at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum, along with clinician-led medication therapy management (MTM) at randomization and every 4 weeks (±14 days). Virtual MTM includes medication reconciliation and assessment, review of labs and dosing, maternal self-care education, adherence counseling, and risk reduction. All intervention participants will receive CHW/SW check-ins; those without identified social needs will receive general support rather than tailored social needs services.

The study will assess BP outcomes, maternal outcomes as well as the overall feasibility and patient satisfaction with the CHW/SW-led NMHRN + Clinician-Led MTM intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Change in mean systolic blood pressure

    Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)

    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.

Secondary outcomes

  1. Recruitment rates

    Time frame: From start of recruitment through completion of enrollment (up to 27 months)

    Measures feasibility by assessing how efficiently eligible participants are recruited into the study. Recruitment performance helps determine scalability of the intervention.

  2. Retention Rate

    Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)

    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.

  3. Technical Reliability of the 4G Blood Pressure Monitoring Device, TSU MH-Rx App, and Text Alerts

    Time frame: Survey at study completion or 10-14 weeks postpartum; technical support tickets from randomization through 10-14 weeks postpartum (up to 54 weeks)

    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).

  4. Participant Satisfaction with study participation

    Time frame: Study completion or 10-14 weeks postpartum

    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.

  5. Scores and Follow-up Interventions from Self-Administered Non-Medical Health Related Needs evaluation (modified Prepare survey)

    Time frame: Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum

    Participant scores from self-administered assessment of non-medical health-related needs will be evaluated. The Non-Medical Health Related Needs evaluation (modified Prepare survey) has a standardized score that ranges from 0-22, where higher scores mean more social needs. The study will also document follow-up actions or interventions triggered by assessment results, including electronic alerts, resource referrals, study team follow-up, and other protocol-defined responses.

  6. Scores and Follow-up Interventions from Self-Administered Anxiety symptom survey (Generalized Anxiety Disorder 7-Item Scale, GAD-7)

    Time frame: Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum

    Participant scores from self-administered assessment of Anxiety symptom will be evaluated. The Anxiety symptom survey (GAD-7 survey) has a standardized score that ranges from 0-21, where higher scores mean worse anxiety symptom. The study will also document follow-up actions or interventions triggered by assessment results, including electronic alerts, resource referrals, study team follow-up, and other protocol-defined responses.

  7. Scores and Follow-up Interventions from Self-Administered Depressive symptom survey (Patient Health Questionnaire-9, PHQ-9)

    Time frame: Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum

    Participant scores from self-administered assessment of depressive symptoms will be evaluated. The Depressive symptom survey (PHQ-9 questionnaire) has a standardized score that ranges from 0-27, where higher scores mean worse Depressive symptom. The study will also document follow-up actions or interventions triggered by assessment results, including electronic alerts, resource referrals, study team follow-up, and other protocol-defined responses.

  8. Scores and Follow-up Interventions from Self-Administered assessment of prenatal care experience (26-Item Person-Centered Prenatal Care Scale, United States: PCPC-US)

    Time frame: At 32-36 weeks' gestation

    Participant scores from self-administered assessment of prenatal care experience will be evaluated. The prenatal experience survey (Person-Centered Prenatal Care scale: PCPC-US) has a standardized score that ranges from 0-100, where 0 is the worst prenatal experience and 100 is the best prenatal experience. The study will also document follow-up actions or interventions triggered by assessment results, including electronic alerts, resource referrals, study team follow-up, and other protocol-defined responses.

  9. Scores and Follow-up Interventions from Self-Administered assessment of intrapartum care experience (35-Item Person-Centered Maternity Care Scale, United States: PCMC-US)

    Time frame: At 10-14 weeks postpartum

    Participant scores from self-administered assessment of intrapartum care experience will be evaluated. The intrapartum experience survey (Person-Centered Maternity Care: PCMC-US) has a standardized score that ranges from 0-100, where 0 is the worst intrapartum experience and 100 is the best intrapartum experience. The study will also document follow-up actions or interventions triggered by assessment results, including electronic alerts, resource referrals, study team follow-up, and other protocol-defined responses.

  10. Blood Pressure Readings and Interventions

    Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)

    Evaluates the Blood pressure readings of participants, alert triggers for abnormal BP reading, the action taken by participants, and the interventions received.

  11. Duration and Type of MTM and CHW/SW Related Activities

    Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)

    Evaluates the Duration and type of MTM and CHW/SW related activities received by participants in the intervention arm.

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Sponsors and collaborators

Lead sponsor

Texas Southern University

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

MH-Rx Study: Comprehensive and Multi-Level Medication Therapy Management and Non-Medical Health Related Needs Targeted Intervention Model for Maternal Health Outcomes. (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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