Monitoring and Testing of Blood Pressure in Postpartum Women

Hypertension Clinical Trial

— SMART-BP  

Official title:

Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236725
• Other study ID #: IRB00077904
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Elizabeth T Jensen, MPH PhD
• Phone: 336-713-3132
• Email: ejensen[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1750
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Remote Blood Pressure Cuff
specialized, Bluetooth enabled BP monitoring cuff
• Blood Pressure (BP) monitoring smart phone app, BabyScripts™
app that works with the monitoring cuff

Behavioral:
• Instructions
Verbal and written instructions to conduct BP checks at home

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validate and calibrate previously developed predictive algorithm	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.	Discharge through week 8 postpartum
Primary	Median number of rBPM measures obtained	Used to determine feasibility of remote blood pressure monitoring intervention (rBPM)	Discharge through Week 3 postpartum
Primary	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	Day 10 postpartum
Primary	Median total cost of health care		From discharge through week 8 postpartum
Primary	Median number of Severe Hypertension events		Discharge through week 1 postpartum
Primary	Median number of Severe Hypertension events		Discharge through week 3 postpartum
Primary	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	Discharge through week 3 postpartum
Secondary	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	Discharge through week 8 postpartum
Secondary	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.	Week 3 postpartum
Secondary	Median Length of Stay (LOS) in hospital after delivery		Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum
Secondary	Median number of hospital readmissions		Discharge through week 8 postpartum
Secondary	Median Length of Stay (LOS) for hospital readmissions		Discharge through week 8 postpartum
Secondary	Median number of women that have a follow-up encounter scheduled with their Primary Care Physician (PCP) within 12 months after delivery		Discharge through 12 months postpartum