Project 3: ACHIEVE- CHD

University Hospitals (UH)

Status: Enrolling

Conditions: Coronary Heart Disease

Treatments: Other: CINEMA; Behavioral: PAL2

Study type: Interventional

Funder types: Other

Identifiers

NCT05918380

STUDY20220763

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 40 to 75 years of age

2. Self-identified as Black or African American

3. Residence in the Cleveland Metro Area

4. 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:

   1. BMI≥30 mg/dL
   2. History of smoking
   3. Elevated blood pressure defined as SBP>140 or DBP>80 mmHg
   4. HbA1c≥5.7%
   5. LDL≥130

5. Able to complete a coronary artery calcium score test (CAC)

6. Willing and able to consent

7. Willing to have a UH provider and UH care

8. Currently insured for standard of care procedures

Exclusion criteria

1. Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke).
2. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
3. Lung disease requiring supplemental oxygen therapy
4. Individuals receiving treatment for cancer related disease
5. Pregnant or nursing mothers

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Low CVD risk

Other group

Description:

PAL2

Treatment:

Behavioral: PAL2

High CVD risk

Other group

Description:

Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)

Treatment:

Other: CINEMA