Postpartum Home Visiting (HEART at Home)

NCT07833904 | Active Not Recruiting

• 2 other identifiers: 202601109T32HL007081
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether HEART at Home (Home-based Engagement And Remote Treatment for Hypertension), a home-based postpartum hypertension care program, is feasible and acceptable for people with high blood pressure after delivery and the health care teams caring for them. The main questions it aims to answer are: Is HEART at Home feasible to deliver, including successful enrollment, completion of home visits and blood pressure monitoring, and delivery of the planned intervention? Is HEART at Home acceptable to participants and health care providers? The study will also explore changes in blood pressure control and track emergency room visits and hospital readmissions related to high blood pressure. Participants will: Measure their blood pressure at home using a provided blood pressure cuff and securely share their readings with the health care team. Receive home visits and phone or text check-ins from trained postpartum doulas for the first three months after delivery. Doulas will provide education, assist with blood pressure monitoring, and help participants connect with ongoing medical care. Have their blood pressure readings reviewed by nurses and doctors, who may adjust blood pressure medications as needed. At 12 weeks after delivery, a plan set for ongoing care with a primary care provider or heart specialist.

Conditions

Hypertensive Disorders of Pregnancy (HDP)

Keywords

postpartum hypertension; community-based care strategies; remote blood pressure monitoring; home visiting

Outcome Measures

Primary Outcomes (2)

• Adoption

  Completion of \>=1 home visit with blood pressure measurement and transmission to clinical team

  continuous across 12 weeks

• Reduction in Systolic BP

  Reduction in Systolic BP

  6 and 12 weeks postpartum

Secondary Outcomes (6)

• Reduction in Diastolic Blood Pressure

  6 weeks and 12 weeks postpartum

• Number of Blood-Pressure Lowering Medication Changes

  Continuous, 2-12 weeks postpartum

• Blood pressure Control

  6 and 12 weeks postpartum

• Fidelity

  continuous, 2-12 weeks postpartum

• Reach

  Baseline (3-5 days postpartum)

Other Outcomes (1)

• Number of unplanned care utilization events (ED visits or hospital readmissions)

  continous, 0-12 weeks postpartum

Study Arms (1)

HEART at Home Cohort

This study includes a single study population: postpartum individuals aged 18 years or older with a diagnosis of a hypertensive disorder of pregnancy who have persistent elevated blood pressure following delivery. There is no control group. All participants are enrolled prospectively. No participants are enrolled under a waiver of consent.Participants will be enrolled at the conclusion of the standard 14-day postpartum rBPM program and followed from weeks 3 through 12 postpartum. Participants will receive three in-person home visits conducted by trained PAT home visitors at approximately 4, 8, and 12 weeks postpartum, consistent with the standard PAT service delivery model.

Behavioral: HEART at Home

Interventions

HEART at Home BEHAVIORAL

The intervention integrates biweekly home visitor-led BP monitoring and health education, extended rBPM through 12 weeks, protocol-driven escalation to the clinical team, and clinician-supervised medication management and telehealth follow-up. Core components of HEART at Home include: 1) home visiting-based BP measurement and support for patient-initiated rBPM between visits, 2) cardiovascular risk assessment and patient education, 3) protocolized clinical escalation and pharmacologic management, and 4) facilitated linkage to longitudinal clinical care.

HEART at Home Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of HDP-including chronic hypertension, gestational hypertension, preeclampsia, eclampsia, HELLP syndrome, or chronic hypertension with superimposed preeclampsia- enrolled at time of delivery.

You may qualify if:

• Age ≥18 years
• Enrollment in the Barnes Jewish Hospital rBPM program; as per eligibility criteria above, patient has a physician-made diagnosis of HDP per American College of Obstetricians and gynecologists criteria
• Measured at least 4 days of blood pressure during initial program
• At least one blood pressure was made after monitoring day 7
• Confirmed at least two separate blood pressure ≥130/80 mm Hg at the end of the 14-day rBPM period
• Ability and willingness to participate in home visits and remote monitoring
• Able to communicate in English or Spanish without the need for interpretation services

You may not qualify if:

• Inability to provide informed consent
• Physician determination of inability to measure blood pressure at home due to comorbidities or other limiting conditions
• No access to a phone

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Parents as Teachers: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Vijay A, Oh I, Lewis A, Sabol BA, Frolova AI, Huffman MD, Mahmoud Z, Rampersad R. Postpartum blood pressure monitoring across hypertensive disorders of pregnancy. Pregnancy Hypertens. 2026 Sep 8;46:101520. doi: 10.1016/j.preghy.2026.101520. Online ahead of print.

  PMID: 42710173 BACKGROUND

Study Officials

• Aishwarya Vijay, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)