Postpartum Hypertension: Remote Patient Monitoring

Overview

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.

Full Title of Study: “Remote Patient Monitoring- Telehealth for Management of Women With Postpartum Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 8, 2018

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

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kara Hoppe, DO, Principal Investigator, Clinical Assistant Professor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.