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NCT Number: NCT05918380

Project 3: ACHIEVE- CHD

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.

Recruiting

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Sanjay Rajagopalan, MD

CONTACT

[email protected]

216-844-5191

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAL2

Behavioral

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.

Other names: Pragmatic personalized, adaptable approach to lifestyle and life circumstance

CINEMA

Other

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.

Primary outcomes

  1. Triple Goal

    Time frame: 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)

Secondary outcomes

  1. Change in HbA1c as measured by blood work

    Time frame: baseline, 12 months

    Percent change in HbA1c

  2. Change in LDL-C as measured by blood work

    Time frame: baseline, 12 months

    Percent change in LDL-C

  3. Change in blood pressure

    Time frame: baseline, 12 months

    Percent change in blood pressure

  4. Change in weight

    Time frame: baseline, 12 months

    Percent change in weight

Other outcomes

  1. Health Visits and Lifestyle Changes - Medical/Mental Health Visits

    Time frame: 12 months after cessation of intervention or 24 months after enrollment

    1-year rate of new medical/mental health visits

  2. Health Visits and Lifestyle Changes - Smoking Cessation

    Time frame: 12 months after cessation of intervention or 24 months after enrollment

    1-year rate of smoking cessation

  3. Health Visits and Lifestyle Changes - Diet

    Time frame: 12 months after cessation of intervention or 24 months after enrollment

    1-year rate of changes in diet

  4. Health Visits and Lifestyle Changes - Activity

    Time frame: 12 months after cessation of intervention or 24 months after enrollment

    1-year rate of changes in activity

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Osborne

CONTACT

[email protected]

216-844-2833

Sanjay Rajagopalan, MD

CONTACT

[email protected]

216-844-5191

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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