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Project 3: ACHIEVE- CHD

ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05918380
Enrollment
500
Registered
2023-06-26
Start date
2022-08-15
Completion date
2027-01-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Health Disparities, African American, Prevention, Coronary Heart Disease

Brief summary

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.

Interventions

BEHAVIORALPAL2

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.

OTHERCINEMA

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.

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Triple Goal12 monthsPercent reaching triple goal of BP \<130/80 mm Hg, HbA1c\<5.7% and LDL-C \<130 mg/dl (\<100 if high-risk)

Secondary

MeasureTime frameDescription
Change in HbA1c as measured by blood workbaseline, 12 monthsPercent change in HbA1c
Change in LDL-C as measured by blood workbaseline, 12 monthsPercent change in LDL-C
Change in blood pressurebaseline, 12 monthsPercent change in blood pressure
Change in weightbaseline, 12 monthsPercent change in weight

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSanjay Rajagopalan, MD

University Hospitals Cleveland Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026