Hypertensive Disorders of PregnancyNCT07842341
MH-Rx Study (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)
A study testing 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 in people with Hypertensive Disorders of Pregnancy and Chronic Hypertension in Pregnancy, run by Texas Southern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy, Chronic Hypertension in Pregnancy, Gestational Hypertension
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Southern University Nabrit Science Building, 3100 Cleburne St.
Houston, Texas, 77004
Veronica Ajewole-Mwema, PharmD, BCOP, 713-313-1217, veronica.ajewole@tsu.edu
Mark Ibarra-Garza, B.Sc, CCRP, 713-313-4349, mark.ibarragarza@tsu.edu
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Hypertensive Disorders of Pregnancy, Chronic Hypertension in Pregnancy, Gestational Hypertension
- Being tested
- 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)
- 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
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 monitoringBehavioural
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Comparator (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
Secondary outcomes (11)
Recruitment rates
Measures feasibility by assessing how efficiently eligible participants are recruited into the study. Recruitment performance helps determine scalability of the intervention.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start25 Sep 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Southern University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Mark Ibarra-Garza, B.Sc, CCRP, Study director, Texas Southern UniversityVeronica Ajewole-Mwema, PharmD, BCOP, Principal investigator, Texas Southern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842341
- Sponsor's protocol ID
- TSU IRB 2224
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07842341
- Acronym / sponsor ID
- TSU IRB 2224
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Texas Southern UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM) | Experimental | 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 monitoringSubjects 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 (Control group) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 monitoringSubjects 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 | Behavioural | CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM) |
| 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 | Behavioural | Active Comparator (Control group) |
Primary outcome
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.
11 secondary outcomes
Recruitment rates
Time frame: From start of recruitment through completion of enrollment (up to 27 months)
Retention Rate
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
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
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)
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)
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)
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)
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)
Time frame: At 10-14 weeks postpartum
Blood Pressure Readings and Interventions
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
Time frame: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Ibarra-Garza, B.Sc, CCRP study director
Texas Southern University
Veronica Ajewole-Mwema, PharmD, BCOP principal investigator
Texas Southern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Hypertensive Disorders of Pregnancy and Chronic Hypertension in Pregnancy, run by Texas Southern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Ajewole-Mwema, PharmD, BCOP (713-313-1217, veronica.ajewole@tsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.