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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
428
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.
UnityPoint Health- Meriter Hospital
Madison, Wisconsin, United States
Aim 1: Number of Participants Enrolled
A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.
Time frame: up to 3 months
Aim 1: Number of Participants Who Completed the Study
To assess retention, the number of participants who completed the study will be reported.
Time frame: up to 6 weeks
Aims 2-5: Number of Participants Enrolled in 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).
Time frame: up to 1 year
Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions
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).
Time frame: up to 6 weeks postpartum
Aim 1: 6-week Hospital Readmission
Time frame: up to 6 weeks
Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge
Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)
Time frame: up to 6 weeks
Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 6 weeks postpartum
Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge
Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).
Time frame: up to 6 weeks
Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits
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).
Time frame: up to 6 weeks postpartum
Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 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).
Time frame: up to 10 days of delivery
Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes
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).
Time frame: up to 6 weeks postpartum
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
Time frame: Admission to delivery (up to 96 hours)
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
Time frame: Admission to delivery (up to 96 hours)
Aims 2-5: Systolic Blood Pressure at Discharge
Time frame: Up to 96 hours postpartum
Aims 2-5: Diastolic Blood Pressure at Discharge
Time frame: Up to 96 hours postpartum
Aims 2-5: Medication at Discharge
Time frame: up to 96 hours postpartum
Aims 2-5: Postpartum Day of Discharge
Time frame: up to 4.5 days
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Time frame: up to 4 days post-partum
Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery
Time frame: 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
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.
Time frame: up to 6 weeks postpartum
Participant Counts for Relevant SAQ Satisfaction Survey Questions
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.
Time frame: up to 6 weeks postpartum