Remote Patient Monitoring - Telehealth for Management of Women With Postpartum Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 428
- 试验地点
- 2
- 主要终点
- Aim 1: Number of Participants Enrolled
研究概览
简要总结
The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System (mobile health) can improve patient satisfaction and quality of care provided to women experiencing complications due to high blood pressure during pregnancy.
详细描述
For six weeks postpartum, patients will use Honeywell Genesis Android Touch Bluetooth System to record and submit their daily blood pressure and weight measurements to a mobile health nurse and research team. Subjects will be provided with the kit (Honeywell tablet, mobile hot spot, blood pressure cuff, and scale) at no cost. Subjects will participate in video telehealth visits at 48 hours and 7 days after discharge to help provide management for hypertension related issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hypertensive disorders of pregnancy including gestational, chronic, or preeclampsia diagnosed in the antenatal (primary admission for delivery of the baby (planned or due to hypertension) or postpartum period as determined by systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 on two occasions 4 hours apart.
- •Gestational age at time of delivery greater than 23 weeks gestation
- •Postpartum with persistent SBP greater than 140 or DBP greater than 90 on two occasions 4 hours apart (to enroll would be prior to discharge from initial postpartum hospital stay).
- •Primary hospital admission for the delivery of the neonate(s).
排除标准
- •Inability to obtain informed consent
研究组 & 干预措施
Mobile Health Participants
Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
干预措施: Mobile Health (Other)
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
结局指标
主要结局
Aim 1: Number of Participants Enrolled
时间窗: up to 3 months
A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.
Aim 1: Number of Participants Who Completed the Study
时间窗: up to 6 weeks
To assess retention, the number of participants who completed the study will be reported.
Aims 2-5: Number of Participants Enrolled in 1 Year
时间窗: up to 1 year
Aims 2-5 primary endpoint is enrollment of up to 40 participants at all times (for a total of 42 days) over one year (220 experimental and 220 matched controls for chart review).
Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions
时间窗: up to 6 weeks postpartum
Comparison of hypertension-related hospital readmissions between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with hypertensive disorders of pregnancy (HDP).
次要结局
- Aim 1: 6-week Hospital Readmission(up to 6 weeks)
- Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge(up to 6 weeks)
- Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits(up to 6 weeks postpartum)
- Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge(up to 6 weeks)
- Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits(up to 6 weeks postpartum)
- Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery(up to 10 days of delivery)
- Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes(up to 6 weeks postpartum)
- Aims 2-5: Maximum Systolic Blood Pressure Intrapartum(Admission to delivery (up to 96 hours))
- Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum(Admission to delivery (up to 96 hours))
- Aims 2-5: Systolic Blood Pressure at Discharge(Up to 96 hours postpartum)
- Aims 2-5: Diastolic Blood Pressure at Discharge(Up to 96 hours postpartum)
- Aims 2-5: Medication at Discharge(up to 96 hours postpartum)
- Aims 2-5: Postpartum Day of Discharge(up to 4.5 days)
- Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use(up to 4 days post-partum)
- Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery(first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy))
- Self-Administered Questionnaire Satisfaction Survey Scores(up to 6 weeks postpartum)
- Participant Counts for Relevant SAQ Satisfaction Survey Questions(up to 6 weeks postpartum)