Hypertension, Pregnancy-Induced
Conditions
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.
Interventions
OTHERMobile Health
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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). |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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. |
| Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum | Admission to delivery (up to 96 hours) | — |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mode of Delivery | at delivery (on average 37-40 weeks of pregnancy) | — |
| Neonatal Intensive Care Unit Admissions | at birth | — |
| Neonatal Birthweight | at time of birth | — |
| Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension. | Up to 12 months | Cost effectiveness modeling will be performed to determine whether it is cost effective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy. |
Countries
United States
Participant flow
Recruitment details
Between March 2017 and July 2017, 55 women were enrolled into a feasibility study for the intervention (Aim 1). Through June 2018, a total of 428 women were enrolled in this study (214 in the intervention group including those from Aim 1 and 214 in the control group). Participants were recruited from Meriter Hospital in Madison, WI.
Participants by arm
| Arm | Count |
|---|---|
| Mobile Health Participants Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Participants will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital. | 214 |
| Standard of Care This arm is a chart review done on hypertensive women who do not participate in using the mobile health device. | 214 |
| Total | 428 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Aim 1: Feasibility and Satisfaction | Withdrawal by Subject | 3 | 0 |
| Aims 2-5: Intervention | Withdrawal by Subject | 19 | 0 |
Baseline characteristics
| Characteristic | Mobile Health Participants | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 5 | 31.5 years STANDARD_DEVIATION 5.5 | 31.5 years STANDARD_DEVIATION 6.5 |
| Delivery BMI | 37.4 kg/m^2 | 36.6 kg/m^2 | 37.0 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 15 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 202 Participants | 199 Participants | 401 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age at delivery Preterm (less than 37 weeks) | 57 Participants | 42 Participants | 99 Participants |
| Gestational age at delivery Term (greater than or equal to 37 weeks) | 157 Participants | 172 Participants | 329 Participants |
| Hypertension Classification Chronic without Superimposed Preeclampsia | 21 Participants | 23 Participants | 44 Participants |
| Hypertension Classification Chronic with Superimposed Preeclampsia | 22 Participants | 23 Participants | 45 Participants |
| Hypertension Classification Gestational | 62 Participants | 79 Participants | 141 Participants |
| Hypertension Classification Preeclampsia | 131 Participants | 112 Participants | 243 Participants |
| Insurance Status Medicaid | 29 Participants | 57 Participants | 86 Participants |
| Insurance Status Private | 185 Participants | 157 Participants | 342 Participants |
| Married | 163 Participants | 149 Participants | 312 Participants |
| Other Subtypes of Hypertension of Interest Eclampsia | 1 Participants | 0 Participants | 1 Participants |
| Other Subtypes of Hypertension of Interest Hemolysis Elevated Liver enzyme Low Platelet (HELLP) | 11 Participants | 1 Participants | 12 Participants |
| Other Subtypes of Hypertension of Interest Mild Preeclampsia | 51 Participants | 63 Participants | 114 Participants |
| Other Subtypes of Hypertension of Interest Severe Preeclampsia | 80 Participants | 49 Participants | 129 Participants |
| Pre-gestational Diabetes Mellitus | 10 Participants | 13 Participants | 23 Participants |
| Pre-pregnancy BMI | 31.8 kg/m^2 | 30.6 kg/m^2 | 31.2 kg/m^2 |
| Primipara | 108 Participants | 91 Participants | 199 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 12 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 25 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 9 Participants | 19 Participants |
| Race (NIH/OMB) White | 175 Participants | 168 Participants | 343 Participants |
| Region of Enrollment United States | 214 participants | 214 participants | 428 participants |
| Sex: Female, Male Female | 214 Participants | 214 Participants | 428 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tobacco Use | 12 Participants | 21 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 214 | 0 / 214 |
| other Total, other adverse events | 0 / 214 | 0 / 214 |
| serious Total, serious adverse events | 0 / 214 | 0 / 214 |
Outcome results
Primary
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
Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aim 1: Number of Participants Enrolled | 55 Participants |
Primary
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
Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aim 1: Number of Participants Who Completed the Study | 52 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Number of Participants Enrolled in 1 Year | 214 Participants |
| Standard of Care | Aims 2-5: Number of Participants Enrolled in 1 Year | 214 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions | 1 Participants |
| Standard of Care | Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions | 8 Participants |
Secondary
Aim 1: 6-week Hospital Readmission
Time frame: up to 6 weeks
Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aim 1: 6-week Hospital Readmission | 0 Participants |
Secondary
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).
Time frame: up to 6 weeks postpartum
Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits | 6 Participants |
Secondary
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
Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge | 29 Participants |
Secondary
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
Population: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge | 9 Participants |
Secondary
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)
Population: Number of participants for which both first prenatal care weight and delivery weight were measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Participants | Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery | 14.6 kilograms | Standard Deviation 8 |
| Standard of Care | Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery | 14.4 kilograms | Standard Deviation 8.4 |
Secondary
Aims 2-5: Diastolic Blood Pressure at Discharge
Time frame: Up to 96 hours postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Diastolic Blood Pressure at Discharge | 78 mmHg |
| Standard of Care | Aims 2-5: Diastolic Blood Pressure at Discharge | 78 mmHg |
Secondary
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Time frame: up to 4 days post-partum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use | 186 Participants |
| Standard of Care | Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use | 189 Participants |
Secondary
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
Time frame: Admission to delivery (up to 96 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum | 101 mmHg |
| Standard of Care | Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum | 102 mmHg |
Secondary
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
Time frame: Admission to delivery (up to 96 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Maximum Systolic Blood Pressure Intrapartum | 160 mmHg |
| Standard of Care | Aims 2-5: Maximum Systolic Blood Pressure Intrapartum | 158 mmHg |
Secondary
Aims 2-5: Medication at Discharge
Time frame: up to 96 hours postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mobile Health Participants | Aims 2-5: Medication at Discharge | Labetalol | 90 Participants |
| Mobile Health Participants | Aims 2-5: Medication at Discharge | Any Antihypertensive | 109 Participants |
| Mobile Health Participants | Aims 2-5: Medication at Discharge | Nifedipine | 39 Participants |
| Standard of Care | Aims 2-5: Medication at Discharge | Any Antihypertensive | 72 Participants |
| Standard of Care | Aims 2-5: Medication at Discharge | Labetalol | 61 Participants |
| Standard of Care | Aims 2-5: Medication at Discharge | Nifedipine | 20 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes | 57 Participants |
| Standard of Care | Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes | 37 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery | 202 Participants |
| Standard of Care | Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery | 129 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits | 10 Participants |
| Standard of Care | Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits | 13 Participants |
Secondary
Aims 2-5: Postpartum Day of Discharge
Time frame: up to 4.5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Health Participants | Aims 2-5: Postpartum Day of Discharge | 3.35 days | Standard Deviation 1.2 |
| Standard of Care | Aims 2-5: Postpartum Day of Discharge | 2.92 days | Standard Deviation 1.1 |
Secondary
Aims 2-5: Systolic Blood Pressure at Discharge
Time frame: Up to 96 hours postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Health Participants | Aims 2-5: Systolic Blood Pressure at Discharge | 131 mmHg |
| Standard of Care | Aims 2-5: Systolic Blood Pressure at Discharge | 129 mmHg |
Secondary
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
Population: Of the 214 participants enrolled in the intervention, 128 participants responded to the 6 week postpartum survey. Not all questions were answered by all survey respondents.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who got help for problems with their devices | 24 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants for whom it took 1 minute to measure their blood pressure | 118 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants for whom it took 5 minutes to measure their blood pressure | 11 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants for whom it took 1 minute to measure their weight | 122 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants for whom it took 5 minutes to measure their weight | 5 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participant who had any problems using the Genesis Touch monitor | 49 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who had any problems using the blood pressure cuff | 108 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who had any problems using the scale | 107 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who had concerns sending their vitals to their health care provider | 4 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who had enough control over their data | 113 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participant who had to go to an emergency room after discharge | 14 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who had a hospital readmission | 3 Participants |
| Mobile Health Participants | Participant Counts for Relevant SAQ Satisfaction Survey Questions | Number of Participants who went to a different hospital than their delivery hospital | 1 Participants |
Secondary
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
Population: Of the 214 participants enrolled in the intervention, 128 participants responded to the 6 week postpartum survey. Not all questions were answered by all survey respondents.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How complicated are mHealth's instructions? | 0.25 score on a scale | Standard Deviation 0.67 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How much mental effort does mHealth require? | 0.59 score on a scale | Standard Deviation 0.74 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How easily does mHealth fit into your lifestyle? | 2.65 score on a scale | Standard Deviation 0.96 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How easy was it to get help? | 3.33 score on a scale | Standard Deviation 0.87 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How confident do you feel using the mHealth devices? | 3.46 score on a scale | Standard Deviation 0.79 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How hard is the monitor to use? | 0.16 score on a scale | Standard Deviation 0.49 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How organized is the monitor? | 3.27 score on a scale | Standard Deviation 0.78 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How helpful are the monitor's prompts? | 2.57 score on a scale | Standard Deviation 1.34 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How burdensome is it to record your weight daily? | 0.78 score on a scale | Standard Deviation 0.98 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How easy is the blood pressure cuff to use? | 3.44 score on a scale | Standard Deviation 0.79 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How hard is the weight scale to use? | 0.37 score on a scale | Standard Deviation 1.06 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How reasonable is the amount of time it takes to record your blood pressure? | 3.46 score on a scale | Standard Deviation 0.77 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How reasonable is the amount of time it takes to record your weight? | 3.47 score on a scale | Standard Deviation 0.79 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How burdensome is it to record your blood pressure daily? | 0.85 score on a scale | Standard Deviation 0.93 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How secure do you feel submitting your vitals? | 3.41 score on a scale | Standard Deviation 0.76 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How much more in control of your own health do you feel? | 2.91 score on a scale | Standard Deviation 0.9 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How much more aware of your own health do you feel? | 3.30 score on a scale | Standard Deviation 0.74 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | Do you prefer going to clinic/hospital instead of using mHealth for postpartum follow-up? | 0.31 score on a scale | Standard Deviation 0.78 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How much would you recommend mHealth to others in your situation? | 3.49 score on a scale | Standard Deviation 0.79 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How enjoyable are the mHealth devices to use? | 2.41 score on a scale | Standard Deviation 1.06 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How satisfied are you with the mHealth devices? | 3.32 score on a scale | Standard Deviation 0.83 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | To what extent does using the mHealth tech make you feel safer? | 2.86 score on a scale | Standard Deviation 0.96 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How often do you feel unsafe while using mHealth? | 0.38 score on a scale | Standard Deviation 1.06 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | How fun is answering questions using the Genesis Touch Monitor? | 2.24 score on a scale | Standard Deviation 1.03 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | Did the Genesis Touch Monitor have all functions you expected? | 3.02 score on a scale | Standard Deviation 0.98 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | Do you like the touch screen technology on the Genesis Touch monitor? | 3.43 score on a scale | Standard Deviation 0.74 |
| Mobile Health Participants | Self-Administered Questionnaire Satisfaction Survey Scores | Does using mHealth make you worry more, less or the same? | 1.23 score on a scale | Standard Deviation 0.63 |
Other Pre-specified
Cost Effective Analysis on Remote Patient Monitoring for Postpartum Hypertension.
Cost effectiveness modeling will be performed to determine whether it is cost effective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy.
Time frame: Up to 12 months
Other Pre-specified
Mode of Delivery
Time frame: at delivery (on average 37-40 weeks of pregnancy)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mobile Health Participants | Mode of Delivery | Vaginal spontaneous | 84 Participants |
| Mobile Health Participants | Mode of Delivery | Cesarean | 114 Participants |
| Mobile Health Participants | Mode of Delivery | Operative vaginal | 16 Participants |
| Standard of Care | Mode of Delivery | Vaginal spontaneous | 112 Participants |
| Standard of Care | Mode of Delivery | Cesarean | 87 Participants |
| Standard of Care | Mode of Delivery | Operative vaginal | 15 Participants |
Other Pre-specified
Neonatal Birthweight
Time frame: at time of birth
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mobile Health Participants | Neonatal Birthweight | 3180 grams |
| Standard of Care | Neonatal Birthweight | 3060 grams |
Other Pre-specified
Neonatal Intensive Care Unit Admissions
Time frame: at birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Health Participants | Neonatal Intensive Care Unit Admissions | 67 Participants |
| Standard of Care | Neonatal Intensive Care Unit Admissions | 55 Participants |