Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health Participants | Experimental | Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum. |
|
| Standard of Care | No Intervention | This arm is a chart review done on hypertensive women who do not participate in using the mobile health device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1: Number of Participants Enrolled | A goal of 55 participants enrolled into the mobile health program was set as a feasibility target. | 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. | 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). | 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). | up to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1: 6-week Hospital Readmission | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kara Hoppe, DO | Clinical Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UnityPoint Health- Meriter Hospital | Madison | Wisconsin | 53715 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32439388 | Result | Hoppe KK, Thomas N, Zernick M, Zella JB, Havighurst T, Kim K, Williams M, Niu B, Lohr A, Johnson HM. Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension. Am J Obstet Gynecol. 2020 Oct;223(4):585-588. doi: 10.1016/j.ajog.2020.05.027. Epub 2020 May 19. No abstract available. | |
| 33607957 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care | This arm is a chart review done on hypertensive women who do not participate in using the mobile health device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aim 1: Feasibility and Satisfaction |
|
| |||||||||||||||||||||||||||
| Aims 2-5: Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aim 1: Number of Participants Enrolled | A goal of 55 participants enrolled into the mobile health program was set as a feasibility target. | Aim 1 was an initial feasibility study enrolling 55 participants into the intervention. | Posted | Count of Participants | Participants | up to 3 months |
|
|
up to 6 weeks post partum
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Hoppe, DO | University of Wisconsin School of Medicine and Public Health | (206) 371-4014 | khoppe2@wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2019 | Apr 29, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). | 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). | 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). | 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). | 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). | up to 6 weeks postpartum |
| 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 | 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. | 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. | up to 6 weeks postpartum |
| Mode of Delivery | at delivery (on average 37-40 weeks of pregnancy) |
| Neonatal Birthweight | at time of birth |
| Neonatal Intensive Care Unit Admissions | at birth |
| Thomas NA, Drewry A, Racine Passmore S, Assad N, Hoppe KK. Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. BMC Pregnancy Childbirth. 2021 Feb 19;21(1):153. doi: 10.1186/s12884-021-03632-9. |
| 30825917 | Result | Hoppe KK, Williams M, Thomas N, Zella JB, Drewry A, Kim K, Havighurst T, Johnson HM. Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregnancy Hypertens. 2019 Jan;15:171-176. doi: 10.1016/j.preghy.2018.12.007. Epub 2018 Dec 31. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Standard of Care |
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-pregnancy BMI | Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Delivery BMI | Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Primipara | First time birth | Count of Participants | Participants |
|
| Hypertension Classification | Count of Participants | Participants |
|
| Other Subtypes of Hypertension of Interest | Count of Participants | Participants |
|
| Married | Count of Participants | Participants |
|
| Tobacco Use | Count of Participants | Participants |
|
| Insurance Status | Count of Participants | Participants |
|
| Pre-gestational Diabetes Mellitus | Count of Participants | Participants |
|
| Gestational age at delivery | Count of Participants | 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. | Aim 1 was an initial feasibility study enrolling 55 participants into the intervention. | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| 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). | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| 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). | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Secondary | Aim 1: 6-week Hospital Readmission | Aim 1 was an initial feasibility study enrolling 55 participants into the intervention. | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| 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) | Aim 1 was an initial feasibility study enrolling 55 participants into the intervention. | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| 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). | Aim 1 was an initial feasibility study enrolling 55 participants into the intervention. | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| 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). | Aim 1 was an initial feasibility study enrolling 55 participants into the intervention. | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| 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). | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| 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). | Posted | Count of Participants | Participants | up to 10 days of delivery |
|
|
|
| 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). | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Secondary | Aims 2-5: Maximum Systolic Blood Pressure Intrapartum | Posted | Median | Inter-Quartile Range | mmHg | Admission to delivery (up to 96 hours) |
|
|
|
| Secondary | Aims 2-5: Maximum Diastolic Blood Pressure Intrapartum | Posted | Median | Inter-Quartile Range | mmHg | Admission to delivery (up to 96 hours) |
|
|
|
| Secondary | Aims 2-5: Systolic Blood Pressure at Discharge | Posted | Median | Inter-Quartile Range | mmHg | Up to 96 hours postpartum |
|
|
|
| Secondary | Aims 2-5: Diastolic Blood Pressure at Discharge | Posted | Median | Inter-Quartile Range | mmHg | Up to 96 hours postpartum |
|
|
|
| Secondary | Aims 2-5: Medication at Discharge | Posted | Count of Participants | Participants | up to 96 hours postpartum |
|
|
|
| Secondary | Aims 2-5: Postpartum Day of Discharge | Posted | Mean | Standard Deviation | days | up to 4.5 days |
|
|
|
| Secondary | Aims 2-5: Inpatient Nonsteroidal Anti-inflammatory Drug (NSAID) Use | Posted | Count of Participants | Participants | up to 4 days post-partum |
|
|
|
| Secondary | Aims 2-5: Change in Weight From First Prenatal Care Visit to Delivery | Number of participants for which both first prenatal care weight and delivery weight were measured. | Posted | Mean | Standard Deviation | kilograms | first prenatal care visit (on average 8-14 weeks of pregnancy, delivery (on average 37-40 weeks of pregnancy) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 6 weeks postpartum |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| 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. | Not Posted | Up to 12 months | Participants |
| Other Pre-specified | Mode of Delivery | Posted | Count of Participants | Participants | at delivery (on average 37-40 weeks of pregnancy) |
|
|
|
| Other Pre-specified | Neonatal Birthweight | Posted | Median | Inter-Quartile Range | grams | at time of birth |
|
|
|
| Other Pre-specified | Neonatal Intensive Care Unit Admissions | Posted | Count of Participants | Participants | at birth |
|
|
|
| 0 |
| 214 |
| 0 |
| 214 |
| 0 |
| 214 |
| EG001 | Standard of Care | This arm is a chart review done on hypertensive women who do not participate in using the mobile health device. | 0 | 214 | 0 | 214 | 0 | 214 |
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Nifedipine |
|
|
| How easily does mHealth fit into your lifestyle? |
|
|
| How easy was it to get help? |
|
|
| How confident do you feel using the mHealth devices? |
|
|
| How hard is the monitor to use? |
|
|
| How organized is the monitor? |
|
|
| How helpful are the monitor's prompts? |
|
|
| How easy is the blood pressure cuff to use? |
|
|
| How hard is the weight scale to use? |
|
|
| How reasonable is the amount of time it takes to record your blood pressure? |
|
|
| How reasonable is the amount of time it takes to record your weight? |
|
|
| How burdensome is it to record your blood pressure daily? |
|
|
| How burdensome is it to record your weight daily? |
|
|
| How secure do you feel submitting your vitals? |
|
|
| How much more in control of your own health do you feel? |
|
|
| How much more aware of your own health do you feel? |
|
|
| Do you prefer going to clinic/hospital instead of using mHealth for postpartum follow-up? |
|
|
| How much would you recommend mHealth to others in your situation? |
|
|
| How enjoyable are the mHealth devices to use? |
|
|
| How satisfied are you with the mHealth devices? |
|
|
| To what extent does using the mHealth tech make you feel safer? |
|
|
| How often do you feel unsafe while using mHealth? |
|
|
| How fun is answering questions using the Genesis Touch Monitor? |
|
|
| Did the Genesis Touch Monitor have all functions you expected? |
|
|
| Do you like the touch screen technology on the Genesis Touch monitor? |
|
|
| Does using mHealth make you worry more, less or the same? |
|
|
|
| Number of Participants for whom it took 5 minutes to measure their blood pressure |
|
|
| Number of Participants for whom it took 1 minute to measure their weight |
|
|
| Number of Participants for whom it took 5 minutes to measure their weight |
|
|
| Number of Participant who had any problems using the Genesis Touch monitor |
|
|
| Number of Participants who had any problems using the blood pressure cuff |
|
|
| Number of Participants who had any problems using the scale |
|
|
| Number of Participants who had concerns sending their vitals to their health care provider |
|
|
| Number of Participants who had enough control over their data |
|
|
| Number of Participant who had to go to an emergency room after discharge |
|
|
| Number of Participants who had a hospital readmission |
|
|
| Number of Participants who went to a different hospital than their delivery hospital |
|
|
| Operative vaginal |
|