ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Triple Goal
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 reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 3 of the ACHIEVE GREATER Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 to 75 years of age
- •Self-identified as Black or African American
- •Residence in the Cleveland Metro Area
- •Must have at least two of the following risk factors identified at a UH health fair screenings, with one risk factor being with SBP, A1c, or LDL:
- •BMI≥30 mg/dL
- •History of smoking
- •Elevated blood pressure defined as SBP>140 or DBP>80 mmHg
- •Able to complete a coronary artery calcium score test (CAC)
- •Willing and able to consent
- •Willing to have a UH provider and UH care
- •Currently insured for standard of care procedures
排除标准
- •Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke).
- •Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
- •Lung disease requiring supplemental oxygen therapy
- •Individuals receiving treatment for cancer related disease
- •Pregnant or nursing mothers
研究组 & 干预措施
Low CVD risk
PAL2
干预措施: PAL2 (Behavioral)
High CVD risk
Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)
干预措施: CINEMA (Other)
结局指标
主要结局
Triple Goal
时间窗: 12 months
Percent reaching triple goal of BP \<130/80 mm Hg, HbA1c\<5.7% and LDL-C \<130 mg/dl (\<100 if high-risk)
次要结局
- Change in blood pressure(baseline, 12 months)
- Change in HbA1c as measured by blood work(baseline, 12 months)
- Change in weight(baseline, 12 months)
- Change in LDL-C as measured by blood work(baseline, 12 months)
研究者
Sanjay Rajagopalan
Chief, Cardiovascular Medicine, Chief Academic and Scientific Officer
University Hospitals Cleveland Medical Center