Clinical trial NCT05918380: Project 3: ACHIEVE- CHD
Official title: ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Health Disparities
African American
Prevention
Coronary Heart Disease
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Triple Goal
timeFrame: 12 months
Secondary outcomes:
measure: Change in HbA1c as measured by blood work
timeFrame: baseline, 12 months
measure: Change in LDL-C as measured by blood work
timeFrame: baseline, 12 months
measure: Change in blood pressure
timeFrame: baseline, 12 months
measure: Change in weight
timeFrame: baseline, 12 months
Other outcomes:
measure: Health Visits and Lifestyle Changes - Medical/Mental Health Visits
timeFrame: 12 months after cessation of intervention or 24 months after enrollment
measure: Health Visits and Lifestyle Changes - Smoking Cessation
timeFrame: 12 months after cessation of intervention or 24 months after enrollment
measure: Health Visits and Lifestyle Changes - Diet
timeFrame: 12 months after cessation of intervention or 24 months after enrollment
measure: Health Visits and Lifestyle Changes - Activity
timeFrame: 12 months after cessation of intervention or 24 months after enrollment
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Sanjay Rajagopalan, MD
role: PRINCIPAL_INVESTIGATOR
References: