HERE: Health Empowerment and Resources After Pregnancy

NCT07701148 | Not Yet Recruiting

• 2 other identifiers: H-467731K23HL165097-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Health

Keywords

Community wellness advocate; Remote blood pressure monitoring; Postpartum; Hypertensive disorders of pregnancy

Outcome Measures

Primary Outcomes (4)

• Acceptability of the intervention

  Acceptability, the perception among stakeholders that the intervention is agreeable, will be measured using the 4-item Acceptability of Intervention Measure. Responses will be collected on a 5-point Likert scale (1-5), and the total score will range from 4-20. Total score will be evaluated as a continuous outcome with higher scores indicating greater acceptability. Results will be separately analyzed among participants, navigators, and other clinical staff.

  4-6 and 12 months postpartum

• Feasibility of the intervention

  Feasibility, the extent to which the intervention can be carried out, will be measured using the 4-item Feasibility of Intervention Measure. Responses will be collected on a 5-point Likert scale (1-5), and the total score will range from 4-20. Total score will be evaluated as a continuous outcome with higher scores indicating greater feasibility.

  4-6 and 12 months postpartum

• Fidelity of the intervention- Penetration

  Penetration or "reach" is defined as the percentage of eligible individuals who were screened. This fidelity related metric will be assessed using a protocol-based checklist and electronic health record data for reference monthly

  monthly for 12 months postpartum

• Fidelity of the intervention- Adherence

  Adherence is defined as the percentage of enrolled participants who were supported by the navigator. This fidelity related metric will be assessed using a protocol-based checklist and electronic health record data for reference monthly.

  monthly for 12 months postpartum

Secondary Outcomes (7)

• Participation Satisfaction

  4-6 and 12 months postpartum

• Linkage to Primary Care

  4-6 and 12 months postpartum

• Cardiovascular Health (CVH)

  2, 4-6, and 12 months postpartum

• Cardiovascular Disease (CVD) Risk Assessment

  12 months postpartum

• Patient Activation

  2, 4-6, and 12 months postpartum

Study Arms (2)

Postpartum patient navigation

EXPERIMENTAL

Participants 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.

Other: Longitudinal patient navigation

Standard of care

ACTIVE COMPARATOR

Participants 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.

Other: Standard care

Interventions

Longitudinal patient navigation OTHER

A 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.

Postpartum patient navigation

Standard care OTHER

Standard 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.

Standard of care

Eligibility Criteria

• Age: 23 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gave birth at Boston Medical Center (BMC) in the past 2 months
• Diagnosis of ≥1 hypertensive disorder of pregnancy during their most recent pregnancy
• Active prescription for ≥1 antihypertensive medication
• Scheduled for follow-up in the postpartum bridge clinic at BMC
• Planning to continue using Boston Medical Center for their health care
• Able and willing to provide informed consent and contact information in English, Spanish, or Haitian Creole (CWA will use hospital interpreter services as needed to communicate with patients with a language preference other than English)

You may not qualify if:

• Diagnosed with cardiovascular disease
• Planning pregnancy in next 3 months
• Planning to move out of Massachusetts within the postpartum year

Sponsors & Collaborators

• Boston Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mara Murray Horwitz, MD, MPH

  Boston Medical Center, General Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Murray Horwitz, MD, MPH

CONTACT

617 638 8034; mara.murrayhorwitz@bmc.org

Ruth Rodriguez, BS

CONTACT

ruth.rodriguez2@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)