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Postpartum Hypertension: Remote Patient Monitoring

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ClinicalTrials.gov Identifier: NCT03111095
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Other: Mobile Health Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Remote Patient Monitoring- Telehealth for Management of Women With Postpartum Hypertension
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : June 8, 2018
Estimated Study Completion Date : June 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile Health Participants
Subjects will use the mobile health device to record their blood pressure and weight measurements everyday for 6 weeks postpartum.
Other: Mobile 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.

No Intervention: Standard of Care
This arm is a chart review done on hypertensive women who do not participate in using the mobile health device.



Primary Outcome Measures :
  1. Is remote patient monitoring program an effective model of care to improve patient satisfaction regarding management of postpartum hypertension? [ Time Frame: Up to 12 months ]
    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 :
  1. Cost effective analysis on remote patient monitoring for postpartum hypertension. [ Time Frame: Up to 12 months ]
    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.

  2. Maternal outcomes in remote patient monitoring vs standard surveillance. [ Time Frame: Up to 12 months ]
    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.

  3. Difference in blood pressures intrapartum and postpartum. [ Time Frame: Up to 12 months ]
    Estimate standard deviations of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) in the intrapartum compared to 24-96 hours postpartum



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111095


Locations
United States, Wisconsin
UnityPoint Health- Meriter Hospital
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kara Hoppe, DO Clinical Assistant Professor

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03111095     History of Changes
Other Study ID Numbers: 2017-003
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications