跳至主要内容
临床试验/NCT06593496
NCT06593496招募中不适用

Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region Project 1 - Epidemiology (ACHIEVE P1-EPI)

Wayne State University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Measure Blood Pressure Protocol Fidelity

研究概览

简要总结

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB# 100221MP2A), the purpose of which is to improve cardiometabolic health in two uniquely comparable cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves separate but related projects that aim to improve cardiometabolic health outcomes through better risk factor control for three chronic conditions that are of tremendous public health importance, (hypertension (HTN), heart failure, and coronary heart disease), all of which contribute significantly to premature death in Detroit and Cleveland.

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 (e.g., social determinants of health) that convey information about baseline BP levels and related clinical outcomes (e.g., follow-up clinic visits, BP control, and cardiovascular events).

详细描述

ACHIEVE P1- EPI aligns with the over-arching theme of the ACHIEVE GREATER center to reduce the burden of chronic cardiovascular disease in the urban Great Lakes region. It focuses on understanding key factors that drive the high prevalence and poor control of hypertension (HTN) in communities across metro 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 and/or 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 progression/remission 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 team's overall care delivery pathways with the goals of improved BP control and reduced cardiometabolic health inequities in Detroit and beyond.

The specific aims are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mobile Health Unit Patients with blood pressure above normal (≥120 systolic and/or ≥80 mmHg)
  • Has a phone with the ability to receive text messages
  • 18+ years old
  • Consent to allow prospective follow-up including through EHR review

排除标准

  • Non-mobile health unit patients
  • MHU patients with systolic BP < 120 mmHg AND diastolic BP < 80 mmHg
  • Pregnant Women
  • Children less than 18 years old
  • Individuals viewed by the investigative team as unable to understand and sign the informed consent form
  • Currently enrolled in another on-going interventional trial initiated on the mobile health unit

结局指标

主要结局

Measure Blood Pressure Protocol Fidelity

时间窗: 12 Months

Achieve a minimum of six (6) measurements of two (2) or more readings of systolic and diastolic blood pressures at baseline, Month 6 and Month 11 within a seven (7) day period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Levy

Professor, Assistant Vice President for Translational Sciences and Clinical Research Innovation

Wayne State University

研究点 (2)

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