Project 3: ACHIEVE- CHD

ConditionCoronary Heart Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-75

SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

40 to 75 years of age

Self-identified as Black or African American

Residence in the Cleveland Metro Area

BMI≥30 mg/dL

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.
CINEMA
Other intervention
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.

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Low CVD riskOther 1 intervention

Group B: High CVD riskOther 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

12 months

Secondary outcomes

Change in HbA1c as measured by blood work

Percent change in HbA1c

Time frame

baseline, 12 months

Change in LDL-C as measured by blood work

Percent change in LDL-C

Time frame

baseline, 12 months

Change in blood pressure

Percent change in blood pressure

Time frame

baseline, 12 months

Change in weight

Percent change in weight

Time frame

baseline, 12 months

Other outcomes

Health Visits and Lifestyle Changes - Medical/Mental Health Visits

1-year rate of new medical/mental health visits

Time frame

12 months after cessation of intervention or 24 months after enrollment

Health Visits and Lifestyle Changes - Smoking Cessation

1-year rate of smoking cessation

Time frame

12 months after cessation of intervention or 24 months after enrollment

Health Visits and Lifestyle Changes - Diet

1-year rate of changes in diet

Time frame

12 months after cessation of intervention or 24 months after enrollment

Health Visits and Lifestyle Changes - Activity

1-year rate of changes in activity

Time frame

12 months after cessation of intervention or 24 months after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov

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