RECRUITING
I'm interested ...!!
Project 3: ACHIEVE- CHD
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.
Conditions:
🦠 Coronary Heart Disease
🗓️ Study Start (Actual) 15 August 2022
🗓️ Primary Completion (Estimated) 1 January 2027
✅ Study Completion (Estimated) 1 January 2027
👥 Enrollment (Estimated) 500
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 40 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 June 2023
  • First Submitted that Met QC Criteria 15 June 2023
  • First Posted 26 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024
I'm interested ...!!