Postpartum Hypertension: Remote Patient Monitoring

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Remote Patient Monitoring- Telehealth for Management of Women With Postpartum Hypertension

Conditions
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Hypertension, Pregnancy-Induced

Intervention / Treatment
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* Other: Mobile Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 SBP >140 or DBP >90 on two occasions 4 hours apart. Gestational age at time of delivery >23 weeks gestation Postpartum with persistent SBP >140 or DBP >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). Exclusion Criteria: Inability to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health Participants<br>Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum. | Other: Mobile Health<br>* Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.<br>|
| No Intervention: Standard of Care<br>This arm is a chart review done on hypertensive women who do not participate in using the mobile health device. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is remote patient monitoring program an effective model of care to improve patient satisfaction regarding management of postpartum hypertension? | Conduct an initial phase study for postpartum women at risk for severe hypertension to estimate the rates of willingness to participate in and utilize remote mobile health applications to monitor home blood pressures and weights, medication adherence after hospital discharge, to inform a trial to decrease postpartum maternal morbidity and readmission. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effective analysis on remote patient monitoring for postpartum hypertension. | Perform a cost effectiveness modeling will be performed to determine whether it is costeffective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy. Primary outcomes examined will include cost and readmissions. | Up to 12 months | 
| Maternal outcomes in remote patient monitoring vs standard surveillance. | Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the cohort of patients with hypertension related disorders discharged with routine care. Outcomes of interest: Incidence of severe hypertension (SBP >150/DBP >105), hospital readmission, initiation of antihypertensive medication, unexpected outpatient clinic/emergency room visit, compliance with medications, compliance with outpatient blood pressure surveillance or scheduled visits, death, stroke. | Up to 12 months | 
| Difference in blood pressures intrapartum and postpartum. | Estimate standard deviations of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) in the intrapartum compared to 24-96 hours postpartum | Up to 12 months |