Trial Outcomes & Findings for Postpartum Hypertension: Remote Patient Monitoring (NCT NCT03111095)
NCT ID: NCT03111095
Last Updated: 2025-08-22
Results Overview
A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.
COMPLETED
NA
428 participants
up to 3 months
2025-08-22
Participant Flow
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.
Participant milestones
| Measure |
Mobile Health Participants
Participants used 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.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Feasibility and Satisfaction
STARTED
|
55
|
0
|
|
Aim 1: Feasibility and Satisfaction
Eligible Participants
|
263
|
0
|
|
Aim 1: Feasibility and Satisfaction
Participants Agreed to be Approached for Study
|
124
|
0
|
|
Aim 1: Feasibility and Satisfaction
Consented to Study
|
55
|
0
|
|
Aim 1: Feasibility and Satisfaction
COMPLETED
|
52
|
0
|
|
Aim 1: Feasibility and Satisfaction
NOT COMPLETED
|
3
|
0
|
|
Aims 2-5: Intervention
STARTED
|
214
|
214
|
|
Aims 2-5: Intervention
Number Analyzed
|
214
|
214
|
|
Aims 2-5: Intervention
COMPLETED
|
195
|
214
|
|
Aims 2-5: Intervention
NOT COMPLETED
|
19
|
0
|
Reasons for withdrawal
| Measure |
Mobile Health Participants
Participants used 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.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Feasibility and Satisfaction
Withdrawal by Subject
|
3
|
0
|
|
Aims 2-5: Intervention
Withdrawal by Subject
|
19
|
0
|
Baseline Characteristics
Postpartum Hypertension: Remote Patient Monitoring
Baseline characteristics by cohort
| Measure |
Mobile Health Participants
n=214 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.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
428 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
214 participants
n=5 Participants
|
214 participants
n=7 Participants
|
428 participants
n=5 Participants
|
|
Pre-pregnancy BMI
|
31.8 kg/m^2
n=5 Participants
|
30.6 kg/m^2
n=7 Participants
|
31.2 kg/m^2
n=5 Participants
|
|
Delivery BMI
|
37.4 kg/m^2
n=5 Participants
|
36.6 kg/m^2
n=7 Participants
|
37.0 kg/m^2
n=5 Participants
|
|
Primipara
|
108 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Hypertension Classification
Chronic without Superimposed Preeclampsia
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Hypertension Classification
Chronic with Superimposed Preeclampsia
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Hypertension Classification
Gestational
|
62 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Hypertension Classification
Preeclampsia
|
131 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Other Subtypes of Hypertension of Interest
Mild Preeclampsia
|
51 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Other Subtypes of Hypertension of Interest
Severe Preeclampsia
|
80 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Other Subtypes of Hypertension of Interest
Hemolysis Elevated Liver enzyme Low Platelet (HELLP)
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Other Subtypes of Hypertension of Interest
Eclampsia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Married
|
163 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Tobacco Use
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Insurance Status
Private
|
185 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Insurance Status
Medicaid
|
29 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Pre-gestational Diabetes Mellitus
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Gestational age at delivery
Preterm (less than 37 weeks)
|
57 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Gestational age at delivery
Term (greater than or equal to 37 weeks)
|
157 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 monthsPopulation: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
A goal of 55 participants enrolled into the mobile health program was set as a feasibility target.
Outcome measures
| Measure |
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Number of Participants Enrolled
|
55 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 6 weeksPopulation: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
To assess retention, the number of participants who completed the study will be reported.
Outcome measures
| Measure |
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Number of Participants Who Completed the Study
|
52 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 1 yearAims 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).
Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Number of Participants Enrolled in 1 Year
|
214 Participants
|
214 Participants
|
PRIMARY outcome
Timeframe: up to 6 weeks postpartumComparison 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).
Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Number of Participants With Hypertension-Related Hospital Readmissions
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
Outcome measures
| Measure |
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: 6-week Hospital Readmission
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
Defined using American College of Obstetricians and Gynecologists (ACOG) criteria blood pressure values of ≥160mmHg (systolic) or ≥110 mmHg (diastolic)
Outcome measures
| Measure |
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Number of Participants With Severe Postpartum Hypertension After Discharge
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeks postpartumPopulation: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
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).
Outcome measures
| Measure |
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Number of Participants With Hypertension-Related Emergency Room Visits
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Aim 1 was an initial feasibility study enrolling 55 participants into the intervention.
Defined as participants having blood pressures exceeding the ACOG recommendations for blood pressure treatment (150/100 mmHg).
Outcome measures
| Measure |
Mobile Health Participants
n=55 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aim 1: Number of Participants With Need for Blood Pressure Treatment After Discharge
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeks postpartumComparison 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).
Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Number of Participants With Hypertension-Related Emergency Room Visits
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 10 days of deliveryComparison 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).
Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Number of Participants With at Least One Blood Pressure Review Within 10 Days of Delivery
|
202 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: up to 6 weeks postpartumComparison 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).
Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Number of Participants on Antihypertensive Treatment Regimes
|
57 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Admission to delivery (up to 96 hours)Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Maximum Systolic Blood Pressure Intrapartum
|
160 mmHg
Interval 152.0 to 171.0
|
158 mmHg
Interval 151.0 to 167.0
|
SECONDARY outcome
Timeframe: Admission to delivery (up to 96 hours)Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum
|
101 mmHg
Interval 96.0 to 110.0
|
102 mmHg
Interval 96.0 to 109.0
|
SECONDARY outcome
Timeframe: Up to 96 hours postpartumOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Systolic Blood Pressure at Discharge
|
131 mmHg
Interval 124.0 to 138.0
|
129 mmHg
Interval 121.0 to 136.0
|
SECONDARY outcome
Timeframe: Up to 96 hours postpartumOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Diastolic Blood Pressure at Discharge
|
78 mmHg
Interval 72.0 to 84.0
|
78 mmHg
Interval 71.0 to 84.0
|
SECONDARY outcome
Timeframe: up to 96 hours postpartumOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Medication at Discharge
Any Antihypertensive
|
109 Participants
|
72 Participants
|
|
Aims 2-5: Medication at Discharge
Labetalol
|
90 Participants
|
61 Participants
|
|
Aims 2-5: Medication at Discharge
Nifedipine
|
39 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: up to 4.5 daysOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Postpartum Day of Discharge
|
3.35 days
Standard Deviation 1.2
|
2.92 days
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: up to 4 days post-partumOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use
|
186 Participants
|
189 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mobile Health Participants
n=212 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=210 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery
|
14.6 kilograms
Standard Deviation 8.0
|
14.4 kilograms
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: up to 6 weeks postpartumPopulation: 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.
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.
Outcome measures
| Measure |
Mobile Health Participants
n=128 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How easy was it to get help?
|
3.33 score on a scale
Standard Deviation 0.87
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How satisfied are you with the mHealth devices?
|
3.32 score on a scale
Standard Deviation 0.83
|
—
|
|
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
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How secure do you feel submitting your vitals?
|
3.41 score on a scale
Standard Deviation 0.76
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How enjoyable are the mHealth devices to use?
|
2.41 score on a scale
Standard Deviation 1.06
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How complicated are mHealth's instructions?
|
0.25 score on a scale
Standard Deviation 0.67
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How much mental effort does mHealth require?
|
0.59 score on a scale
Standard Deviation 0.74
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How easily does mHealth fit into your lifestyle?
|
2.65 score on a scale
Standard Deviation 0.96
|
—
|
|
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
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How hard is the monitor to use?
|
0.16 score on a scale
Standard Deviation 0.49
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How organized is the monitor?
|
3.27 score on a scale
Standard Deviation 0.78
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How helpful are the monitor's prompts?
|
2.57 score on a scale
Standard Deviation 1.34
|
—
|
|
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
|
—
|
|
Self-Administered Questionnaire Satisfaction Survey Scores
How hard is the weight scale to use?
|
0.37 score on a scale
Standard Deviation 1.06
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeks postpartumPopulation: 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.
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.
Outcome measures
| Measure |
Mobile Health Participants
n=128 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had a hospital readmission
|
3 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who got help for problems with their devices
|
24 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
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 5 minutes to measure their blood pressure
|
11 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 1 minute to measure their weight
|
122 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants for whom it took 5 minutes to measure their weight
|
5 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participant who had any problems using the Genesis Touch monitor
|
49 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had any problems using the blood pressure cuff
|
108 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had any problems using the scale
|
107 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
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who had enough control over their data
|
113 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participant who had to go to an emergency room after discharge
|
14 Participants
|
—
|
|
Participant Counts for Relevant SAQ Satisfaction Survey Questions
Number of Participants who went to a different hospital than their delivery hospital
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 monthsCost 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at delivery (on average 37-40 weeks of pregnancy)Outcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Mode of Delivery
Vaginal spontaneous
|
84 Participants
|
112 Participants
|
|
Mode of Delivery
Cesarean
|
114 Participants
|
87 Participants
|
|
Mode of Delivery
Operative vaginal
|
16 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time of birthOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Neonatal Birthweight
|
3180 grams
Interval 2660.0 to 3540.0
|
3060 grams
Interval 2610.0 to 3490.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at birthOutcome measures
| Measure |
Mobile Health Participants
n=214 Participants
Participants will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
|
Standard of Care
n=214 Participants
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
|
|---|---|---|
|
Neonatal Intensive Care Unit Admissions
|
67 Participants
|
55 Participants
|
Adverse Events
Mobile Health Participants
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kara Hoppe, DO
University of Wisconsin School of Medicine and Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place