Health TrialsbyHealthPanel

HERE: Health Empowerment and Resources After Pregnancy

ConditionCardiovascular Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age23+
SponsorBoston Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed with cardiovascular disease

Planning pregnancy in next 3 months

Planning to move out of Massachusetts within the postpartum year

Trial design

Design model

Parallel

Treatments tested in this trial

  • Longitudinal patient navigation

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Postpartum patient navigationExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4-6 and 12 months postpartum
2

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.

Time frame
4-6 and 12 months postpartum
3

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

Time frame
monthly for 12 months postpartum
4

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.

Time frame
monthly for 12 months postpartum

Secondary outcomes

1

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.

Time frame
4-6 and 12 months postpartum
2

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.

Time frame
4-6 and 12 months postpartum
3

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.

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

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.

Time frame
12 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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