HERE: Health Empowerment and Resources After Pregnancy
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Boston Medical Center
- Study ID
- NCT07701148
- Status
- Not Yet Recruiting
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Conditions
- Cardiovascular Health
Eligibility Criteria
- Sex
- FEMALE
- Age
- 23 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Longitudinal patient navigation — OTHERA Community Wellness Advocate (CWA) will provide longitudinal patient navigation-proactive check-ins, assistance with appointment attendance scheduling and planning, identification of barriers to care, follow-up after missed appointments, mental health and social needs screening, and connections to appropriate resources. The CWA will serve as a consistent point of contact throughout the postpartum year.
- Standard care — OTHERStandard care includes education on postpartum hypertension, a blood pressure cuff for self-monitoring, and assistance with scheduling follow-up care, including referral to a postpartum bridge clinic in General Internal Medicine.
Study Details
This study will examine whether a patient navigation program can help improve long-term heart health among people who experienced high blood pressure disorders during pregnancy at Boston Medical Center (BMC). Conditions such as preeclampsia and other hypertensive disorders of pregnancy increase a person's risk of developing cardiovascular disease later in life. However, many patients do not receive timely follow-up care after pregnancy, especially once routine postpartum care ends. about 60 participants will be randomly assigned to one of two groups. One group will receive standard care, which includes clinician-directed counseling about cardiovascular risk and recommendations for follow-up care. The other group will receive support from a patient navigator in addition to standard care. Patient navigators, also known as Community Wellness Advocates (CWAs), are trained staff who help patients connect with health services, understand their health risks, and navigate the healthcare system. The main goals of the study are to determine whether this navigation program is practical to implement and acceptable to patients and healthcare providers. Researchers will also examine whether the program improves follow-up with primary care, cardiovascular risk assessment, and engagement in heart-healthy behaviors. Information will be collected from medical records, surveys, and interviews with participants and healthcare staff. Participants will be followed for one year
Key Dates
- First listed
- Jul 14, 2026
- Start date
- Sep 30, 2026
- Status verified
- Jul 2026
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Postpartum patient navigationParticipants randomized to this intervention arm will receive longitudinal patient navigation from a Community Wellness Advocate (CWA) who will provide ongoing support after discharge at \~6-8 weeks post partum from the perinatal remote blood pressure monitoring (RBPM) program.
- Active Comparator: Standard of careParticipants randomized to this control arm will continue with standard care for a year after discharge from the hospital's perinatal RBPM program at \~6-8 weeks postpartum.
Primary Outcome Measure
Acceptability of the intervention [ Time Frame: 4-6 and 12 months postpartum ]
Central Contacts
- Mara Murray Horwitz, MD, MPH617 638 8034
- Ruth Rodriguez, BS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 |
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