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Project 3: ACHIEVE- CHD

Primary Purpose

Coronary Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAL2
CINEMA
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring Health Disparities, African American, Prevention, Coronary Heart Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low CVD risk

High CVD risk

Arm Description

PAL2

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in HbA1c as measured by blood work
Percent change in HbA1c
Change in LDL-C as measured by blood work
Percent change in LDL-C
Change in blood pressure
Percent change in blood pressure
Change in weight
Percent change in weight

Full Information

First Posted
June 5, 2023
Last Updated
June 15, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05918380
Brief Title
Project 3: ACHIEVE- CHD
Official Title
ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Health Disparities, African American, Prevention, Coronary Heart Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low CVD risk
Arm Type
Other
Arm Description
PAL2
Arm Title
High CVD risk
Arm Type
Other
Arm Description
Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)
Intervention Type
Behavioral
Intervention Name(s)
PAL2
Other Intervention Name(s)
Pragmatic personalized, adaptable approach to lifestyle and life circumstance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CINEMA
Intervention Description
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 Outcome Measure Information:
Title
Triple Goal
Description
Percent reaching triple goal of BP <130/80 mm Hg, HbA1c<5.7% and LDL-C <130 mg/dl (<100 if high-risk)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in HbA1c as measured by blood work
Description
Percent change in HbA1c
Time Frame
baseline, 12 months
Title
Change in LDL-C as measured by blood work
Description
Percent change in LDL-C
Time Frame
baseline, 12 months
Title
Change in blood pressure
Description
Percent change in blood pressure
Time Frame
baseline, 12 months
Title
Change in weight
Description
Percent change in weight
Time Frame
baseline, 12 months
Other Pre-specified Outcome Measures:
Title
Health Visits and Lifestyle Changes - Medical/Mental Health Visits
Description
1-year rate of new medical/mental health visits
Time Frame
12 months after cessation of intervention or 24 months after enrollment
Title
Health Visits and Lifestyle Changes - Smoking Cessation
Description
1-year rate of smoking cessation
Time Frame
12 months after cessation of intervention or 24 months after enrollment
Title
Health Visits and Lifestyle Changes - Diet
Description
1-year rate of changes in diet
Time Frame
12 months after cessation of intervention or 24 months after enrollment
Title
Health Visits and Lifestyle Changes - Activity
Description
1-year rate of changes in activity
Time Frame
12 months after cessation of intervention or 24 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay Rajagopalan, MD
Phone
216-844-5191
Email
Sanjay.Rajagopalan@uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Osborne
Phone
216-844-2833
Email
heidi.osborne@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Rajagopalan, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Rajagopalan, MD
Phone
216-844-5191
Email
Sanjay.Rajagopalan@uhhospitals.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Project 3: ACHIEVE- CHD

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