Project 3: ACHIEVE- CHD

Not Applicable

Recruiting

• Conditions: Coronary Heart Disease
• Interventions: Other: CINEMA; Behavioral: PAL2

• Registration Number: NCT05918380
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High CVD risk	CINEMA	Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)
Low CVD risk	PAL2	PAL2

Primary Outcome Measures

Name	Time	Method
Triple Goal	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 Outcome Measures

Name	Time	Method
Change in weight	baseline, 12 months	Percent change in weight
Change in blood pressure	baseline, 12 months	Percent change in blood pressure
Change in HbA1c as measured by blood work	baseline, 12 months	Percent change in HbA1c
Change in LDL-C as measured by blood work	baseline, 12 months	Percent change in LDL-C

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States