RecruitingNot applicable

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for pregnant women with high blood pressure that started before or during pregnancy. It tests whether adding online support for social needs and medicine care visits to home blood pressure checks improves blood pressure and pregnancy health. Everyone will check their blood pressure at home and use the TSU MH Rx app, but only one group will get the added support.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are female and pregnant, at 34 weeks or earlier.
  • Can provide medical proof of pregnancy and how far along you are.
  • Are 18 to 45 years old.
  • Have high blood pressure that started before or during pregnancy.
  • Currently take at least one medicine.
  • Use a smartphone.
  • Can speak and read English.
  • Can fill out surveys on your own and check your blood pressure at home.

Who can't join

  • Cannot legally agree to take part in the study.
  • Cannot attend study sessions and complete surveys during pregnancy and for 14 weeks after giving birth.
  • Cannot speak and read English.
  • Cannot or do not want to give reliable contact details, such as a phone number, email, or address.
  • Cannot or do not want to share the basic health history needed to check if you qualify.
  • Cannot or do not want to provide medical proof of pregnancy and how far along you are.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TX