[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657634":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":59,"studyPopulation":53,"armGroups":60,"interventions":73,"overallOfficials":82,"centralContacts":89,"locations":97,"responsibleParty":114,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":53,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":53,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":152,"whyStopped":53,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Texas Southern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"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)",[14,18,21,25,29,33,36,39,43,47,50],{"measure":15,"description":16,"timeFrame":17},"Recruitment rates","Measures feasibility by assessing how efficiently eligible participants are recruited into the study. Recruitment performance helps determine scalability of the intervention.","From start of recruitment through completion of enrollment (up to 27 months)",{"measure":19,"description":20,"timeFrame":12},"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.",{"measure":22,"description":23,"timeFrame":24},"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\u002Fcharging 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\u002Fapp alert delivery, and other troubleshooting).","Survey at study completion or 10-14 weeks postpartum; technical support tickets from randomization through 10-14 weeks postpartum (up to 54 weeks)",{"measure":26,"description":27,"timeFrame":28},"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\u002FSocial 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.","Study completion or 10-14 weeks postpartum",{"measure":30,"description":31,"timeFrame":32},"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.","Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum",{"measure":34,"description":35,"timeFrame":32},"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.",{"measure":37,"description":38,"timeFrame":32},"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.",{"measure":40,"description":41,"timeFrame":42},"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.","At 32-36 weeks' gestation",{"measure":44,"description":45,"timeFrame":46},"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.","At 10-14 weeks postpartum",{"measure":48,"description":49,"timeFrame":12},"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.",{"measure":51,"description":52,"timeFrame":12},"Duration and Type of MTM and CHW\u002FSW Related Activities","Evaluates the Duration and type of MTM and CHW\u002FSW related activities received by participants in the intervention arm.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":6,"observationalModel":53,"timePerspective":53,"maskingInfo":57},"RANDOMIZED","PARALLEL",{"masking":58,"maskingDescription":53,"whoMasked":53},"NONE","This randomized controlled trial will evaluate the effectiveness of combining Community Health Worker (CHW)\u002FSocial 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).\n\nAll 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\u002Fapp 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\u002FOBGYN follow-up.\n\nOnly intervention-arm subjects will receive virtual CHW\u002FSW-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\u002FSW check-ins; those without identified social needs will receive general support rather than tailored social needs services.\n\nThe study will assess BP outcomes, maternal outcomes as well as the overall feasibility and patient satisfaction with the CHW\u002FSW-led NMHRN + Clinician-Led MTM intervention.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"CHW\u002FSW-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\u002Fneonatal outcomes. They will also receive virtual CHW\u002FSW-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\u002FSW check-ins at each of these three points; those without identified social needs will receive general check-ins rather than targeted interventions.",[66],"Behavioral: Community Health Worker (CHW)\u002FSocial Worker (SW)-led non-medical health related needs (NMHRN) intervention + Clinician-Led Medication Therapy Management (MTM) with remote blood pressure monitoring",{"label":68,"type":69,"description":70,"interventionNames":71},"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\u002FSocial 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.",[72],"Behavioral: Active Comparator (Control group)",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":53},"BEHAVIORAL","Community Health Worker (CHW)\u002FSocial 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\u002Fapp alerts for abnormal readings.\n\nThey 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",[62],{"type":75,"name":68,"description":80,"armGroupLabels":81,"otherNames":53},"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\u002Fapp alerts for abnormal readings.\n\nThey 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",[68],[83,86],{"name":84,"affiliation":5,"role":85},"Mark Ibarra-Garza, B.Sc, CCRP","STUDY_DIRECTOR",{"name":87,"affiliation":5,"role":88},"Veronica Ajewole-Mwema, PharmD, BCOP","PRINCIPAL_INVESTIGATOR",[90,94],{"name":87,"role":91,"phone":92,"phoneExt":53,"email":93},"CONTACT","713-313-1217","veronica.ajewole@tsu.edu",{"name":84,"role":91,"phone":95,"phoneExt":53,"email":96},"713-313-4349","mark.ibarragarza@tsu.edu",[98],{"facility":99,"status":53,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Texas Southern University Nabrit Science Building, 3100 Cleburne St.","Houston","Texas","77004","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-95.36327,29.76328,{"lat":109,"lon":108},[112,113],{"name":87,"role":91,"phone":92,"phoneExt":53,"email":93},{"name":84,"role":91,"phone":95,"phoneExt":53,"email":96},{"type":115,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[117],{"name":118,"class":119},"Health Resources and Services Administration (HRSA)","FED","100657634","mh-rx-study-baby-on-board-check-in-on-you-your-medication--your-blood-pressure-100657634",false,"NCT07842341","MH-Rx Study (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)","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)","Inclusion Criteria:\n\n* Female, pregnant ≤34 weeks\n* Pregnancy Status: Pregnant, up to 34 weeks of gestation. Able to provide medical confirmation of pregnancy\n* Age 18-45\n* Diagnosis of chronic hypertension or Gestational Hypertension ( i.e: high blood pressure that was present before pregnancy or developed during pregnancy).\n* Currently taking ≥1 medication\n* Smartphone user\n* Able to speak and read English\n* Ability to participate in self-led surveys and perform remote blood pressure monitoring\n\nExclusion Criteria:\n\n* Inability to Provide Legal Consent: Individuals who cannot legally consent to participate in the research study will be excluded.\n* 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.\n* Language Barrier: Individuals who do not speak and read English.\n* Inability or Unwillingness to Provide Required Information: Individuals who are unable or unwilling to provide reliable contact information (phone, email, or address for app\u002Ftext-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).","FEMALE","18 Years","45 Years",{"count":131,"type":132},158,"ESTIMATED","INTERVENTIONAL",[135],"NA","This randomized controlled trial will evaluate whether adding Community Health Worker (CHW)\u002FSocial 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).\n\nAll 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.",[138,139,140],"Hypertensive Disorders of Pregnancy","Chronic Hypertension in Pregnancy","Gestational Hypertension",[138,142,140,143,144,145,146,147,148,149,150,151],"Preeclampsia","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","NOT_YET_RECRUITING","2026-09-21",{"date":155,"type":156},"2026-09-25","ACTUAL",{"date":158,"type":132},"2026-09-09",{"date":160,"type":132},"2029-12-30",{"name":5,"class":6},1]