Postpartum Hypertension: Remote Patient Monitoring

Hypertension, Pregnancy-Induced Clinical Trial

Official title:

Remote Patient Monitoring- Telehealth for Management of Women With Postpartum Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111095
• Other study ID #: 2017-003
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: June 11, 2018

Study information

• Verified date: April 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: June 11, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced

Intervention

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.

Locations

Country	Name	City	State
United States	UnityPoint Health- Meriter Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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	Up to 12 months