Monitoring and Testing of Blood Pressure in Postpartum Women
- Conditions
- Hypertension
- Interventions
- Device: Remote Blood Pressure CuffDevice: Blood Pressure (BP) monitoring smart phone app, BabyScripts™Behavioral: Instructions
- Registration Number
- NCT05236725
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1602
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote Blood Pressure Monitoring (rBPM) Remote Blood Pressure Cuff 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 Remote Blood Pressure Monitoring (rBPM) Instructions 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 Remote Blood Pressure Monitoring (rBPM) Blood Pressure (BP) monitoring smart phone app, BabyScripts™ 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
- Primary Outcome Measures
Name Time Method Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines Day 10 postpartum Impact of rBPM on adherence to ACOG recommendations
Median total cost of health care From discharge through week 8 postpartum Median number of Severe Hypertension events Discharge through week 3 postpartum Median number of encounters for urgent or emergent care Discharge through week 3 postpartum Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities
Median number of rBPM measures obtained Discharge through Week 3 postpartum Used to determine feasibility of remote blood pressure monitoring intervention (rBPM)
- Secondary Outcome Measures
Name Time Method Median number of hospital readmissions Discharge through week 8 postpartum Median Length of Stay (LOS) for hospital readmissions Discharge through week 8 postpartum Median Length of Stay (LOS) in hospital after delivery Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum Median number of encounters for urgent or emergent care Discharge through week 8 postpartum 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 Week 3 postpartum 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 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
Trial Locations
- Locations (1)
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States