Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647511
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to use digital health tracking to improve how we detect high blood pressure and other health issues in pregnant refugee women The main questions the 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 comorbiditiesrisks associated with pregnancy
Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements
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 comorbiditiesrisks associated with pregnancy
Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements
Detailed Description:
The objective of this application funded by the National Academy of Medicine Catalyst Award is to maximize the performance of a digital cardiovascular monitoring system to detect gestational hypertension in pregnant refugee women The central hypothesis is that the application of these digital health technologies will be able to diagnose gestational hypertension in refugee mothers with 85 sensitivity as compared to the gold standard clinical diagnosis The rationale for this investigation is to improve the diagnosis of hypertension in refugee mothers leading to targeted treatment
This studys primary objective is to maximize the performance of digital health monitoring systems to detect gestational hypertension through system training and validation We aim to do this by utilizing technologies such as smartwatches and electronic blood pressure monitors to track health data throughout enrollment Tracking this health data will also allow us to track several other comorbid conditions in refugee mothers This collection will take place over 24 months to train and validate this digital system The performance of our prediction models will be assessed using two measures Receiver Operating Characteristic ROC curve analysis which evaluates the models discrimination ability between disease states and the Integrated Brier Score cumulative mean squared error over time will provide data on the models predictive accuracy and reliability
The secondary objectives of this study are to document comorbid illness and stress assess the programs ability to make successful referrals and connect the study population with healthcare providers for primary care visits This will be completed by digital health tracking and the retention of contact with the participants throughout the duration of their enrollment
This studys primary objective is to maximize the performance of digital health monitoring systems to detect gestational hypertension through system training and validation We aim to do this by utilizing technologies such as smartwatches and electronic blood pressure monitors to track health data throughout enrollment Tracking this health data will also allow us to track several other comorbid conditions in refugee mothers This collection will take place over 24 months to train and validate this digital system The performance of our prediction models will be assessed using two measures Receiver Operating Characteristic ROC curve analysis which evaluates the models discrimination ability between disease states and the Integrated Brier Score cumulative mean squared error over time will provide data on the models predictive accuracy and reliability
The secondary objectives of this study are to document comorbid illness and stress assess the programs ability to make successful referrals and connect the study population with healthcare providers for primary care visits This will be completed by digital health tracking and the retention of contact with the participants throughout the duration of their enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None