Cardiovascular HealthHERENCT07701148
HERE: Health Empowerment and Resources After Pregnancy
A study testing Longitudinal patient navigation in people with Cardiovascular Health, run by Boston Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 23 years and older, women only
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Longitudinal patient navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gave birth at Boston Medical Center (BMC) in the past 4 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)
Who cannot join
- Diagnosed with cardiovascular disease
- Planning pregnancy in next 3 months
- Planning to move out of Massachusetts within the postpartum year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ruth Rodriguez, BS contact
United States1 site
Boston Medical Center
Boston, Massachusetts, 02118
Mara Murray Horwitz, MD MPH, 617-638-8034, Mara.MurrayHorwitz@bmc.org
About this study
Official 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
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
- Being tested
- Longitudinal patient navigation, Standard care
- Keywords
- Community wellness advocate, Remote blood pressure monitoring, Postpartum, Hypertensive disorders of pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal patient navigationOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: monthly for 12 months postpartum
Secondary outcomes (7)
Participation Satisfaction
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.
Measured: 4-6 and 12 months postpartum
Linkage to Primary Care
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.
Measured: 4-6 and 12 months postpartum
Cardiovascular Health (CVH)
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.
Measured: 2, 4-6, and 12 months postpartum
Cardiovascular Disease (CVD) Risk Assessment
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.
Measured: 12 months postpartum
Patient Activation
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.
Measured: 2, 4-6, and 12 months postpartum
Bridge Clinic Attendance
The measure will be the percentage of participants with a completed bridge clinic appointment between >6 weeks and 4 months postpartum.
Measured: 2, 4-6, and 12 months postpartum
CVD risk perception
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.
Measured: 2, 4-6, and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mara Murray Horwitz, MD, MPH, Principal investigator, Boston Medical Center, General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701148
- Sponsor's protocol ID
- H-46773
- Other IDs
- 1K23HL165097-01A1
- Acronym
- HERE
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07701148
- Acronym / sponsor ID
- HERE / H-46773
- Conditions
- Cardiovascular Health
- Keywords
- Community wellness advocate, Remote blood pressure monitoring, Postpartum, Hypertensive disorders of pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum patient navigation | Experimental | Other: Longitudinal 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. |
| Standard of care | Active comparator | Other: Standard 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. |
Who may qualify
- Ages
- 23 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gave birth at Boston Medical Center (BMC) in the past 4 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
Key exclusion criteria (3 listed)
- Diagnosed with cardiovascular disease
- Planning pregnancy in next 3 months
- Planning to move out of Massachusetts within the postpartum year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal patient navigationA 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. | Other | Postpartum patient navigation |
| Standard careStandard 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. | Other | Standard of care |
Primary outcome
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.
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.
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
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.
7 secondary outcomes
Participation Satisfaction
Time frame: 4-6 and 12 months postpartum
Linkage to Primary Care
Time frame: 4-6 and 12 months postpartum
Cardiovascular Health (CVH)
Time frame: 2, 4-6, and 12 months postpartum
Cardiovascular Disease (CVD) Risk Assessment
Time frame: 12 months postpartum
Patient Activation
Time frame: 2, 4-6, and 12 months postpartum
Bridge Clinic Attendance
Time frame: 2, 4-6, and 12 months postpartum
CVD risk perception
Time frame: 2, 4-6, and 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Health
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruth Rodriguez, BS contact
Mara Murray Horwitz, MD, MPH principal investigator
Boston Medical Center, General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal patient navigation in people with Cardiovascular Health, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Murray Horwitz, MD, MPH (617 638 8034, mara.murrayhorwitz@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: 4-6 and 12 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.