HEART at Home: Improving Postpartum Cardiovascular Outcomes Through Implementation of a Hybrid Home-Based and Remote Blood Pressure Management Model for Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adoption
研究概览
简要总结
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.
详细描述
High blood pressure during and after pregnancy can put people at risk for serious health problems after delivery. Many patients do not receive enough follow-up care once they leave the hospital, and high blood pressure can continue or worsen in the weeks after childbirth.
This study will test whether a new care approach is practical and acceptable for patients and health care teams. The study combines home blood pressure monitoring, home visits by trained postpartum doulas, and telehealth visits with medical providers during the first three months after delivery. This novel intervention is called HEART at Home (Home-based Engagement And Remote Treatment for Hypertension).
People who recently gave birth and have ongoing high blood pressure will be invited to join the study. Participants will measure their blood pressure at home using a provided cuff and share their readings through a secure mobile system. Nurses and doctors will review these readings and adjust blood pressure medications when needed. Participants will also receive home visits and phone or text check-ins from trained postpartum doulas, who will provide education, help with blood pressure measurement, and support in connecting to ongoing medical care. At about 12 weeks after delivery, participants will have planning for future care with a primary care provider or heart specialist.
The study will collect information about how easy the program is to carry out, how often participants complete visits, and how helpful participants and providers find the program. The study will also track blood pressure control and any emergency room visits or hospital readmissions related to blood pressure. This information will be used to improve postpartum care for people with high blood pressure in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
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.
干预措施: HEART at Home (Behavioral)
结局指标
主要结局
Adoption
时间窗: continuous across 12 weeks
Completion of \>=1 home visit with blood pressure measurement and transmission to clinical team
Reduction in Systolic BP
时间窗: 6 and 12 weeks postpartum
Reduction in Systolic BP
次要结局
- 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))
- Time-Based Cost(continuous, 2-12 weeks)