Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593496
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region Project 1 - Epidemiology ACHIEVE P1-EPI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region Project 1 - Epidemiology ACHIEVE P1-EPI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This project is part of the ACHIEVE GREATER Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region Center IRB 100221MP2A the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities Detroit Michigan and Cleveland Ohio The ACHIEVE GREATER Center involves separate but related projects that aim to mitigate and understand health disparities in risk factor control of chronic conditions hypertension heart failure and coronary heart disease which drive downstream lifespan inequality The present study is the prospective observational cohort component of ACHIEVE P1- EPI Project 1 of the ACHIEVE GREATER Center and serves to characterize the population of patients with blood pressure BP levels above normal attending The Wayne Health Mobile Health Unit MHU events to better understand key factors eg social determinants of health that convey information about baseline BP levels and related clinical outcomes eg follow-up clinic visits BP control
Detailed Description:
ACHIEVE P1- EPI aligns with the over-arching theme of the ACHIEVE GREATER center to reduce disparities in cardiovascular risk factors and disease faced by members of the adult Black community in the urban Great Lakes region It focuses on understanding key factors that drive the high prevalence and poor control of hypertension HTN in the Black community in Detroit Much of this risk traces to social vulnerability and pervasive negative social determinants of health SDoH which impact access and quality of care ACHIEVE P1- EPI is comprised of two main components 1 a retrospective analysis of all MHU patients starting in April 2020 IRB-23-04-5726 and 2 development of a prospective observational sub-cohort of MHU patients that consent to on-going follow up of their health care utilization and outcomes a subset of whom will also consent to receive a home BP monitor where utilization of the device will be monitored
This project focuses on the prospective component ACHIEVE P1- EPI Prospective to enable the study team to characterize critical risk factors and track associations with subsequent health outcomes to inform a comprehensive preventative strategy to lower blood pressure BP and improve the control of early-stage HTN in the Detroit area
ACHIEVE P1- EPI proposes an epidemiological approach to characterize key factors that convey information about baseline BP levels andor that drive subsequent health outcomes Using a combination of retrospective and prospective observational analytical approaches the study team will leverage the Wayne Health Mobile Health Unit MHU platform to implement an observational cohort study that will characterize the antecedents correlates and sequelae of abnormal blood pressure The investigator and study team will also perform a nested randomized trial to determine if text message prompts improve the amount or quality of data collected remotely
Key issues requiring elucidation are the prevalence and predictors of negative SDoH among patients as well as their associations with screening BP levels and trajectories the role of SDoH and other factors in determining the progressionremission of high BP over the following year the rates and predictors of successful linkages with follow-up medical visits and receiving social services the rates and predictors of the initiation of BP-lowering medications in subsequent clinical care the persistence and predictors of follow-up clinical visits and treatments the barriers and facilitators of linkages into the healthcare system and the ultimate success rates and predictors of reaching BP goals Answers to these questions will provide invaluable information to help guide data-driven improvements to the MHU program moving forward and inform future scalability in other regions and locations These results will assist us in the optimizing and up-scaling of the program including the development of improved strategies to successfully link individuals to social services and follow-up healthcare The findings will help enhance the study teams overall care delivery pathways with the goals of improved BP control and reduced cardiometabolic health inequities in Detroit and beyond
The specific aims are
AIM-1 To develop a prospective observational cohort to observe subsequent health outcomes eg blood pressure levels cardiometabolic risk factors clinic visits medications cardiovascular events following MHU participation using Wayne health EMR dataset for follow-up The study team will assess baseline predictors eg SDoH medications demographics of subsequent health outcomes and plan to probe area- and person-level profiles as potential sources of variation in appropriately developed multilevel models
AIM-2 To develop a nested randomized trial of a sub-cohort to test for differences in adherence to a blood pressure measurement protocol among an intervention group that receives text message reminders and controls who instead receive standard of care without text message reminders We will also test for differences in blood pressure profiles and secondarily emergency department utilization at 12-month follow-up
This project focuses on the prospective component ACHIEVE P1- EPI Prospective to enable the study team to characterize critical risk factors and track associations with subsequent health outcomes to inform a comprehensive preventative strategy to lower blood pressure BP and improve the control of early-stage HTN in the Detroit area
ACHIEVE P1- EPI proposes an epidemiological approach to characterize key factors that convey information about baseline BP levels andor that drive subsequent health outcomes Using a combination of retrospective and prospective observational analytical approaches the study team will leverage the Wayne Health Mobile Health Unit MHU platform to implement an observational cohort study that will characterize the antecedents correlates and sequelae of abnormal blood pressure The investigator and study team will also perform a nested randomized trial to determine if text message prompts improve the amount or quality of data collected remotely
Key issues requiring elucidation are the prevalence and predictors of negative SDoH among patients as well as their associations with screening BP levels and trajectories the role of SDoH and other factors in determining the progressionremission of high BP over the following year the rates and predictors of successful linkages with follow-up medical visits and receiving social services the rates and predictors of the initiation of BP-lowering medications in subsequent clinical care the persistence and predictors of follow-up clinical visits and treatments the barriers and facilitators of linkages into the healthcare system and the ultimate success rates and predictors of reaching BP goals Answers to these questions will provide invaluable information to help guide data-driven improvements to the MHU program moving forward and inform future scalability in other regions and locations These results will assist us in the optimizing and up-scaling of the program including the development of improved strategies to successfully link individuals to social services and follow-up healthcare The findings will help enhance the study teams overall care delivery pathways with the goals of improved BP control and reduced cardiometabolic health inequities in Detroit and beyond
The specific aims are
AIM-1 To develop a prospective observational cohort to observe subsequent health outcomes eg blood pressure levels cardiometabolic risk factors clinic visits medications cardiovascular events following MHU participation using Wayne health EMR dataset for follow-up The study team will assess baseline predictors eg SDoH medications demographics of subsequent health outcomes and plan to probe area- and person-level profiles as potential sources of variation in appropriately developed multilevel models
AIM-2 To develop a nested randomized trial of a sub-cohort to test for differences in adherence to a blood pressure measurement protocol among an intervention group that receives text message reminders and controls who instead receive standard of care without text message reminders We will also test for differences in blood pressure profiles and secondarily emergency department utilization at 12-month follow-up
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