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Monitoring and Testing of Blood Pressure in Postpartum Women (SMART-BP)

Primary Purpose

Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Remote Blood Pressure Cuff

Blood Pressure (BP) monitoring smart phone app, BabyScripts™

Instructions

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring postpartum, blood pressure, women, blood pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC
Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
Currently resides in Forsyth County, NC
18 years of age or older
Able to read and understand either English or Spanish
Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Exclusion Criteria:

Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
Resides outside of Forsyth County, NC
Under 18 years of age
Unable to read or understand either English or Spanish
Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Sites / Locations

Atrium Health Wake Forest BaptistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care (SOC)

Remote Blood Pressure Monitoring (rBPM)

Arm Description

Subjects randomized to SOC arm are provided with the appropriate standard of care depending upon their risk level (as determined by their individual provider or WFBMC Maternal-Fetal Medicine provider)

Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring: a specialized, Bluetooth enabled BP monitoring cuff (Clinically Validated, A&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2) BP monitoring smart phone app, BabyScripts™ Verbal and written instructions, to conduct BP checks at home

Outcomes

Primary Outcome Measures

Median number of rBPM measures obtained

Used to determine feasibility of remote blood pressure monitoring intervention (rBPM)

Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines

Impact of rBPM on adherence to ACOG recommendations

Median total cost of health care

Median number of Severe Hypertension events

Median number of encounters for urgent or emergent care

Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities

Secondary Outcome Measures

Median number of encounters for urgent or emergent care

Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities

Acceptability of rBPM in postpartum period

Survey to determine subject's level of satisfaction with use of the rBPM tools. Survey responses will be compared among subjects from varying demographic and socioeconomic groups. Survey is designed utilizing a Likert-type scale with 1-2 being higher level of acceptability, 3 being neutral, and 4-5 being lower level of acceptability of the rBPM tools. Study team will report the overall proportion and estimate the proportion of women with higher vs. lower levels of acceptability among women of different demographic and socioeconomic groups. This aim only applies to the women in the treatment (rBPM) arm.

Median Length of Stay (LOS) in hospital after delivery

Median number of hospital readmissions

Median Length of Stay (LOS) for hospital readmissions

Median number of women that have a follow-up encounter scheduled with their Primary Care Physician (PCP) within 12 months after delivery

Full Information

NCT ID

NCT05236725

First Posted

January 28, 2022

Last Updated

December 23, 2022

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05236725

Brief Title

Monitoring and Testing of Blood Pressure in Postpartum Women

Acronym

SMART-BP

Official Title

Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high BP, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high BP can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote BP after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor BPs without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their BP remotely after delivery found out that this was both possible and acceptable.

Detailed Description

This is a randomized control trial (RCT). All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, NC that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART- BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit". This nurse home visit occurs via phone call, telehealth visit, or an in person visit ~2 weeks after delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

postpartum, blood pressure, women, blood pressure monitoring

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care (SOC)

Arm Type

No Intervention

Arm Description

Arm Title

Remote Blood Pressure Monitoring (rBPM)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Remote Blood Pressure Cuff

Intervention Description

specialized, Bluetooth enabled BP monitoring cuff

Intervention Type

Device

Intervention Name(s)

Blood Pressure (BP) monitoring smart phone app, BabyScripts™

Intervention Description

app that works with the monitoring cuff

Intervention Type

Behavioral

Intervention Name(s)

Instructions

Intervention Description

Verbal and written instructions to conduct BP checks at home

Primary Outcome Measure Information:

Title

Median number of rBPM measures obtained

Description

Used to determine feasibility of remote blood pressure monitoring intervention (rBPM)

Time Frame

Discharge through Week 3 postpartum

Title

Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines

Description

Impact of rBPM on adherence to ACOG recommendations

Time Frame

Day 10 postpartum

Title

Median total cost of health care

Time Frame

From discharge through week 8 postpartum

Title

Median number of Severe Hypertension events

Time Frame

Discharge through week 1 postpartum

Title

Median number of Severe Hypertension events

Time Frame

Discharge through week 3 postpartum

Title

Median number of encounters for urgent or emergent care

Description

Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities

Time Frame

Discharge through week 3 postpartum

Secondary Outcome Measure Information:

Title

Median number of encounters for urgent or emergent care

Description

Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities

Time Frame

Discharge through week 8 postpartum

Title

Acceptability of rBPM in postpartum period

Description

Time Frame

Week 3 postpartum

Title

Median Length of Stay (LOS) in hospital after delivery

Time Frame

Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum

Title

Median number of hospital readmissions

Time Frame

Discharge through week 8 postpartum

Title

Median Length of Stay (LOS) for hospital readmissions

Time Frame

Discharge through week 8 postpartum

Title

Median number of women that have a follow-up encounter scheduled with their Primary Care Physician (PCP) within 12 months after delivery

Time Frame

Discharge through 12 months postpartum

Other Pre-specified Outcome Measures:

Title

Validate and calibrate previously developed predictive algorithm

Description

Intended to assess the performance of the predictive algorithm in identifying postpartum high blood pressure readmissions. Study team will utilize blood pressure measures obtained through 3 weeks postpartum, as well as any hypertensive disorders of pregnancy events postpartum through 8 weeks postpartum, to include ED/Urgent Care/OB Triage encounters and any readmissions. The predictive algorithm is informed by information documented in the electronic health record, prior to delivery and during pregnancy.

Time Frame

Discharge through week 8 postpartum

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center Currently resides in Forsyth County, NC 18 years of age or older Able to read and understand either English or Spanish Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan Exclusion Criteria: Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist Resides outside of Forsyth County, NC Under 18 years of age Unable to read or understand either English or Spanish Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth T Jensen, MPH PhD

Phone

336-713-3132

ejensen@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth T Jensen, MPH PhD

Organizational Affiliation

Atrium Health Wake Forest Baptist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Atrium Health Wake Forest Baptist

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth T Jensen, MPH PhD

Phone

336-713-3132

ejensen@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Elizabeth T Jensen, MPH PhD

12. IPD Sharing Statement

Plan to Share IPD

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