An interventional study of 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 and Active Comparator (Control group) in Hypertensive Disorders of Pregnancy, Chronic Hypertension in Pregnancy and Gestational Hypertension, sponsored by Texas Southern University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Texas Southern University · Not applicable, Interventional, and Other
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.
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.
262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.
This study's planned enrollment of 158 is close to the median of 147 across 174 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →Texas Southern University is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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)
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
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
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.
Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
Recruitment rates
Measures feasibility by assessing how efficiently eligible participants are recruited into the study. Recruitment performance helps determine scalability of the intervention.
Time frame: From start of recruitment through completion of enrollment (up to 27 months)
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.
Time frame: 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
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).
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)
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.
Time frame: Study completion or 10-14 weeks postpartum
Scores and Follow-up Interventions from Self-Administered Non-Medical Health Related Needs evaluation (modified Prepare survey)
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.
Time frame: Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum
Scores and Follow-up Interventions from Self-Administered Anxiety symptom survey (Generalized Anxiety Disorder 7-Item Scale, GAD-7)
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.
Time frame: Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum
Scores and Follow-up Interventions from Self-Administered Depressive symptom survey (Patient Health Questionnaire-9, PHQ-9)
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.
Time frame: Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum
Scores and Follow-up Interventions from Self-Administered assessment of prenatal care experience (26-Item Person-Centered Prenatal Care Scale, United States: PCPC-US)
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.
Time frame: At 32-36 weeks' gestation
Scores and Follow-up Interventions from Self-Administered assessment of intrapartum care experience (35-Item Person-Centered Maternity Care Scale, United States: PCMC-US)
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.
Time frame: At 10-14 weeks postpartum
Blood Pressure Readings and Interventions
Evaluates the Blood pressure readings of participants, alert triggers for abnormal BP reading, the action taken by participants, and the interventions received.
Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
Duration and Type of MTM and CHW/SW Related Activities
Evaluates the Duration and type of MTM and CHW/SW related activities received by participants in the intervention arm.
Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
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Texas Southern University