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

NCT07842341 | Not Yet Recruiting

• 1 other identifier: TSU IRB 2224
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Hypertensive Disorders of Pregnancy; Preeclampsia; Gestational Hypertension; Remote Blood Pressure Monitoring; Medication Therapy Management; Community Health Worker; Non-Medical Health Related Needs; Maternal Health; Postpartum Care; Digital Health; Social Worker; Social Needs

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (11)

• Recruitment rates

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

• Retention Rate

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

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

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

• Participant Satisfaction with study participation

  Study completion or 10-14 weeks postpartum

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

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

Study Arms (2)

CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM)

EXPERIMENTAL

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.

Behavioral: 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

Active Comparator (Control group)

ACTIVE COMPARATOR

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.

Behavioral: Active Comparator (Control group)

Interventions

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

Active Comparator (Control group)

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

CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Texas Southern University: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Texas Southern University Nabrit Science Building, 3100 Cleburne St.

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Interventions

Community Health Workers; Methods; myotubularin; Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design

Study Officials

• Mark Ibarra-Garza, B.Sc, CCRP

  Texas Southern University

  STUDY DIRECTOR

• Veronica Ajewole-Mwema, PharmD, BCOP

  Texas Southern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Ajewole-Mwema, PharmD, BCOP

CONTACT

713-313-1217; veronica.ajewole@tsu.edu

Mark Ibarra-Garza, B.Sc, CCRP

CONTACT

713-313-4349; mark.ibarragarza@tsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 25, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)