The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are:
* Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation? * Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers? * Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure?
Participants will:
* Complete baseline and follow-up in-person appointments; * Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy; * Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.
Pregnant
Refugee, asylum seeking, or asylee as designated by the U.S. Government
Greater than or equal to 18 years of age
Has a personal smartphone
Unable to provide informed consent
Determined by the PI to be in an extremely vulnerable position and therefore not suited for research participation
Planned move from the New York City (NYC) area within the next 24 months
The study population is a pregnant refugee, or asylee as designated by the U.S. Government.
Cohort
Prospective
Nokia-Withings BPM Connect Blood Pressure Monitor
DeviceAt-home blood pressure (BP) measurements will be weekly via a blood pressure cuff (e.g., Nokia-Withings BPM (Beats per Minute) Connect), with measurements being manually entered into the study specific smartphone app.
Smartwatch Devices
DevicePassive continuous collection of digital data (e.g., daily heart rate trends, activity levels, sleep measurements) for exploratory outcomes will occur via Apple Watches and Fitbit Versa 3s, which are synced to a smartphone application.
Digital Sensitivity for detecting gestational hypertension (HTN)
The diagnostic accuracy of the digital blood pressure cuffs will be compared to the measurements taken during in-person visits.
Number of Participants that Complete All Surveys Between Appointments
The completion of weekly surveys will be assessed for each participant and the number of participants that complete all surveys sent to them will be compared to the overall number of participants enrolled.
Number of Participants That Complete All Surveys at the Baseline Appointment
The number of participants that complete every single survey at the baseline appointment out of the total number of participants will be recorded.
Number of Participants Referred to Physicians/Care that do not have a designated provider
Participants without designated care providers during their pregnancy will be noted and the number of participants that are successfully referred to physicians/other providers will be recorded.
Number of Participants With No Comorbid Pain as Assessed by BPI-SF
Chronic pain will be evaluated using the validated Brief Pain Inventory - Short Form (BPI-SF). The mean BPI-SF score quantifies pain severity (worst, least, average, and now) and pain interference into the following: none (score 0), mild (1-4), moderate (4-6), or severe (7-10).The number of participants who score 0 on the BPI-SF will be measured.
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Academy of Medicine
Collaborator
Cornell University
Collaborator
Apple Inc.
Collaborator
