Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07701148

HERE: Health Empowerment and Resources After Pregnancy

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

23 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location contact

Mara Murray Horwitz, MD MPH

CONTACT

[email protected]

617-638-8034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Acceptability of the intervention

    Time frame: 4-6 and 12 months postpartum

    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.

  2. Feasibility of the intervention

    Time frame: 4-6 and 12 months postpartum

    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.

  3. Fidelity of the intervention- Penetration

    Time frame: monthly for 12 months postpartum

    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

  4. Fidelity of the intervention- Adherence

    Time frame: monthly for 12 months postpartum

    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.

Secondary outcomes

  1. Participation Satisfaction

    Time frame: 4-6 and 12 months postpartum

    Satisfaction will be measured using the 18-item Patient Satisfaction Questionnaire (PSQ-18). Each item is rated on a 5-point Likert scale (strongly agree to strongly disagree), and items are grouped into 7 dimensions of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each dimension is measured by 2-4 items. After reverse-coding negatively worded items, we will calculate the mean response score (1-5) for each dimension, with higher scores indicating greater satisfaction with care.

  2. Linkage to Primary Care

    Time frame: 4-6 and 12 months postpartum

    The measure will be the percentage of participants with a completed primary care visit, excluding Bridge clinic appointments, occurring between >6 weeks and 1 year postpartum.

  3. Cardiovascular Health (CVH)

    Time frame: 2, 4-6, and 12 months postpartum

    CVH will be defined using the American Heart Association's Life's Essential 8 construct, which scores each of 8 domains from 0 to 100 and generates an overall CVH score as the unweighted average of the 8 component scores (0 = worst, 100 = best heart health). The 8 components of CVH are- diet, physical activity, sleep, nicotine exposure, body mass index, blood lipids, blood glucose, and blood pressure. Diet, physical activity, sleep, and nicotine exposure will be assessed by self-report via survey. Body mass index, blood lipids, blood glucose, and blood pressure will be drawn from the electronic health record (using values closest to the assessment window), and EHR-documented tobacco use will corroborate self-reported nicotine exposure. Each domain subscore (0-100) will be calculated per Life's Essential 8 and generate the overall CVH score as the unweighted average of the 8 domains.

  4. Cardiovascular Disease (CVD) Risk Assessment

    Time frame: 12 months postpartum

    Cardiovascular disease risk assessment will be defined as completion of both glycemic control testing (OGTT or A1c) and lipids testing between >6 weeks and 1 year postpartum. This will be assessed from the electronic health record based on completed lab testing.

  5. Patient Activation

    Time frame: 2, 4-6, and 12 months postpartum

    Patient activation, a composite measure of knowledge, skills, and confidence to become actively engaged in one's own health care, will be assessed using the 10-item Consumer Health Activation Index (CHAI). Scores range from 0-100 and are categorized as follows: 0-79 = Low activation; 80-94 = Moderate activation; 95-100 = High activation.

  6. Bridge Clinic Attendance

    Time frame: 2, 4-6, and 12 months postpartum

    The measure will be the percentage of participants with a completed bridge clinic appointment between >6 weeks and 4 months postpartum.

  7. CVD risk perception

    Time frame: 2, 4-6, and 12 months postpartum

    Participants will be asked about their level of concern for their future heart health, on a 4-point scale. Descriptive statistics will be calculated on this outcome as an ordered categorical variable.

Study contacts

Contact information is provided by the study sponsor or research team.

Mara Murray Horwitz, MD, MPH

CONTACT

[email protected]

617 638 8034

Ruth Rodriguez, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

HERE: Health Empowerment and Resources After Pregnancy A Pilot Randomized Controlled Trial of Patient Navigation to Improve Linkage to Primary Care After Hypertensive Disorders of Pregnancy

Acronym: HERE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.