Project 3: ACHIEVE- CHD

NCT05918380 | Recruiting

• 1 other identifier: STUDY20220763
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Health Disparities; African American; Prevention; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in HbA1c as measured by blood work

  baseline, 12 months

• Change in LDL-C as measured by blood work

  baseline, 12 months

• Change in blood pressure

  baseline, 12 months

• Change in weight

  baseline, 12 months

Other Outcomes (4)

• Health Visits and Lifestyle Changes - Medical/Mental Health Visits

  12 months after cessation of intervention or 24 months after enrollment

• Health Visits and Lifestyle Changes - Smoking Cessation

  12 months after cessation of intervention or 24 months after enrollment

• Health Visits and Lifestyle Changes - Diet

  12 months after cessation of intervention or 24 months after enrollment

Study Arms (2)

Low CVD risk

OTHER

PAL2

Behavioral: PAL2

High CVD risk

OTHER

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

Other: CINEMA

Interventions

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.

Also known as: Pragmatic personalized, adaptable approach to lifestyle and life circumstance

Low CVD risk

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.

High CVD risk

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Interventions

Motion Pictures

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Sanjay Rajagopalan, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Rajagopalan, MD

CONTACT

216-844-5191; Sanjay.Rajagopalan@uhhospitals.org

Heidi Osborne

CONTACT

216-844-2833; heidi.osborne@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiovascular Medicine, Chief Academic and Scientific Officer

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 26, 2023
• Study Start: August 15, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)