Project 3: ACHIEVE- CHD

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05918380
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 52.6
• Patients Per Site Per Month: 9.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Behavioral: PAL2; Other: CINEMA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
• Actual Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Low CVD risk PAL2	Behavioral: PAL2; 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
Other: High CVD risk Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)	Other: CINEMA; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in HbA1c as measured by blood work [baseline, 12 months]

   Percent change in HbA1c

2. Change in LDL-C as measured by blood work [baseline, 12 months]

   Percent change in LDL-C

3. Change in blood pressure [baseline, 12 months]

   Percent change in blood pressure

4. Change in weight [baseline, 12 months]

   Percent change in weight

Other Outcome Measures

1. Health Visits and Lifestyle Changes - Medical/Mental Health Visits [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 [12 months after cessation of intervention or 24 months after enrollment]

   1-year rate of smoking cessation

3. Health Visits and Lifestyle Changes - Diet [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 [12 months after cessation of intervention or 24 months after enrollment]

   1-year rate of changes in activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

5. BMI≥30 mg/dL

6. History of smoking

7. Elevated blood pressure defined as SBP>140 or DBP>80 mmHg

8. HbA1c≥5.7%

9. LDL≥130

10. Able to complete a coronary artery calcium score test (CAC)

11. Willing and able to consent

12. Willing to have a UH provider and UH care

13. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Sanjay Rajagopalan, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjay Rajagopalan, Chief, Cardiovascular Medicine, Chief Academic and Scientific Officer, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT05918380
• Other Study ID Numbers: STUDY20220763
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sanjay Rajagopalan, Chief, Cardiovascular Medicine, Chief Academic and Scientific Officer, University Hospitals Cleveland Medical Center: Health Disparities; African American; Prevention; Coronary Heart Disease
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Jun 26, 2023