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Postpartum Hypertension: Remote Patient Monitoring

Primary Purpose

Hypertension, Pregnancy-Induced

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension, Pregnancy-Induced

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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 SBP >140 or DBP >90 on two occasions 4 hours apart.
  • Gestational age at time of delivery >23 weeks gestation
  • Postpartum with persistent SBP >140 or DBP >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

Sites / Locations

  • UnityPoint Health- Meriter Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Health Participants

Standard of Care

Arm Description

Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.

This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.

Outcomes

Primary Outcome Measures

Is remote patient monitoring program an effective model of care to improve patient satisfaction regarding management of postpartum hypertension?
Conduct an initial phase study for postpartum women at risk for severe hypertension to estimate the rates of willingness to participate in and utilize remote mobile health applications to monitor home blood pressures and weights, medication adherence after hospital discharge, to inform a trial to decrease postpartum maternal morbidity and readmission.

Secondary Outcome Measures

Cost effective analysis on remote patient monitoring for postpartum hypertension.
Perform a cost effectiveness modeling will be performed to determine whether it is costeffective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy. Primary outcomes examined will include cost and readmissions.
Maternal outcomes in remote patient monitoring vs standard surveillance.
Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the cohort of patients with hypertension related disorders discharged with routine care. Outcomes of interest: Incidence of severe hypertension (SBP >150/DBP >105), hospital readmission, initiation of antihypertensive medication, unexpected outpatient clinic/emergency room visit, compliance with medications, compliance with outpatient blood pressure surveillance or scheduled visits, death, stroke.
Difference in blood pressures intrapartum and postpartum.
Estimate standard deviations of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) in the intrapartum compared to 24-96 hours postpartum

Full Information

First Posted
March 24, 2017
Last Updated
April 9, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03111095
Brief Title
Postpartum Hypertension: Remote Patient Monitoring
Official Title
Remote Patient Monitoring- Telehealth for Management of Women With Postpartum Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy-Induced

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Health Participants
Arm Type
Experimental
Arm Description
Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.
Intervention Type
Other
Intervention Name(s)
Mobile Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Is remote patient monitoring program an effective model of care to improve patient satisfaction regarding management of postpartum hypertension?
Description
Conduct an initial phase study for postpartum women at risk for severe hypertension to estimate the rates of willingness to participate in and utilize remote mobile health applications to monitor home blood pressures and weights, medication adherence after hospital discharge, to inform a trial to decrease postpartum maternal morbidity and readmission.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Cost effective analysis on remote patient monitoring for postpartum hypertension.
Description
Perform a cost effectiveness modeling will be performed to determine whether it is costeffective to use remote patient modeling for women with postpartum hypertension in comparison to standard outpatient care in women with hypertension-related disorders of pregnancy. Primary outcomes examined will include cost and readmissions.
Time Frame
Up to 12 months
Title
Maternal outcomes in remote patient monitoring vs standard surveillance.
Description
Compare the maternal outcomes in the cohort utilizing remote patient monitoring to the cohort of patients with hypertension related disorders discharged with routine care. Outcomes of interest: Incidence of severe hypertension (SBP >150/DBP >105), hospital readmission, initiation of antihypertensive medication, unexpected outpatient clinic/emergency room visit, compliance with medications, compliance with outpatient blood pressure surveillance or scheduled visits, death, stroke.
Time Frame
Up to 12 months
Title
Difference in blood pressures intrapartum and postpartum.
Description
Estimate standard deviations of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) in the intrapartum compared to 24-96 hours postpartum
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 SBP >140 or DBP >90 on two occasions 4 hours apart. Gestational age at time of delivery >23 weeks gestation Postpartum with persistent SBP >140 or DBP >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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara Hoppe, DO
Organizational Affiliation
Clinical Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UnityPoint Health- Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33607957
Citation
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.
Results Reference
derived

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Postpartum Hypertension: Remote Patient Monitoring

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