Postpartum Hypertension: Remote Patient Monitoring

Not Applicable

Completed

Conditions: Hypertension, Pregnancy-Induced

Interventions: Other: Mobile Health

Registration Number: NCT03111095

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 428

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 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).

Exclusion Criteria

Inability to obtain informed consent

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Health Participants	Mobile Health	Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.

Primary Outcome Measures

Name	Time	Method
Aim 1: Number of Participants Enrolled	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	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	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	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).

Secondary Outcome Measures

Name	Time	Method
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	Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)
Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits	up to 6 weeks postpartum	Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).
Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge	up to 6 weeks	Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).
Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits	up to 6 weeks postpartum	Comparison of hypertension-related emergency room visits between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).
Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery	up to 10 days of delivery	Comparison of number of participants with at least one blood pressure review within 10 days of delivery between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).
Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes	up to 6 weeks postpartum	Comparison of number of participants on antihypertensive treatments between home telehealth with remote BP monitoring group and standard outpatient care during the first 6 weeks postpartum in women with HDP (hypertensive disorders of pregnancy).
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	In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of mean scores (1-5) are reported here.
Participant Counts for Relevant SAQ Satisfaction Survey Questions	up to 6 weeks postpartum	In collaboration with the University of Wisconsin Survey Center, the investigators developed a 37-question self-administered questionnaire (SAQ) satisfaction survey to all participants at the 6-week postpartum clinic visit. The survey utilized a variety of question formats including Likert scales with response ranging from 1 to 5 ("Not at all"; "A little"; "Somewhat"; "Quite a bit"; "A great deal" or "Never"; "Rarely"; "Sometimes"; "Very often"; "Extremely often"), dichotomous questions with a Yes/No response, and free text. A summary of questions with participant counts is reported here.