Project 3: ACHIEVE- CHD

Study Overview
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Brief Summary
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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 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.

Official Title
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ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: PAL2
* Other: CINEMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 HbA1c≥5.7% LDL≥130 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low CVD risk<br>PAL2 | Behavioral: PAL2<br>* Low CVD risk participants (CAC < 100) will be followed by their primary care provider accompanied by monthly contact with community health workers provided by ACHIEVE Greater who will screen participants for social determinants of health and implement the PAL2. PAL2 is defined as a community health worked based intervention to mitigate psychosocial and health equity barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education.<br>* Other names: Pragmatic personalized, adaptable approach to lifestyle and life circumstance;|
| Other: High CVD risk<br>Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) | Other: CINEMA<br>* High CVD risk participants (CAC ≥ 100) will be followed by specialists in the Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) at UHCMC. While they too will be assessed, by the CHW for SDOH and a plan developed to address them, this plan will be addressed by the usual resources available in the CINEMA clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triple Goal | Percent reaching triple goal of BP <130/80 mm Hg, HbA1c<5.7% and LDL-C <130 mg/dl (<100 if high-risk) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c as measured by blood work | Percent change in HbA1c | baseline, 12 months | 
| Change in LDL-C as measured by blood work | Percent change in LDL-C | baseline, 12 months | 
| Change in blood pressure | Percent change in blood pressure | baseline, 12 months | 
| Change in weight | Percent change in weight | baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Disparities, African American, Prevention, Coronary Heart Disease