Recruiting

CHW & MTM

Sponsor:

Texas Southern University

Code:

NCT07842341

Conditions

Hypertensive Disorders of Pregnancy

Chronic Hypertension in Pregnancy

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 45

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

Active Comparator (Control group)

Study Details

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

Study ID

NCT07842341

Start date

Sep 25, 2026

Status verified date

Oct, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

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

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)

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 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 and Locations

Central contacts

Veronica Ajewole-Mwema, PharmD, BCOP

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

Mark Ibarra-Garza, B.Sc, CCRP

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

Locations

Texas Southern University Nabrit Science Building, 3100 Cleburne St.

Recruiting

Houston, Texas, United States, 77004

Contacts

Veronica Ajewole-Mwema, PharmD, BCOP

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

Mark Ibarra-Garza, B.Sc, CCRP

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

More Information

Sponsor

Texas Southern University

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Texas Southern University on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.