Intervention Program for Coronary Heart Disease

N/A

Recruiting

Led By Sanjay Rajagopalan, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

40 to 75 years of age

Be older than 18 years old

Must not have

Lung disease requiring supplemental oxygen therapy

Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after cessation of intervention or 24 months after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is reducing cardiometabolic health disparities & lifespan inequality in Detroit & Cleveland by providing an evidence-based intervention program & training to optimize CHW competence & adherence.

Who is the study for?

This trial is for Black or African American individuals aged 40-75 living in the Cleveland Metro Area, with certain risk factors like high body mass index (BMI), history of smoking, elevated blood pressure, high HbA1c or LDL levels. They must be able to undergo a coronary artery calcium score test and consent to treatment by a UH provider within their insurance coverage.

What is being tested?

Project 3: ACHIEVE-CHD is testing an intervention program called PAL2 delivered by Community Health Workers. It's part of a larger effort to reduce health disparities in heart disease management among populations at risk in Detroit and Cleveland.

What are the potential side effects?

Since this study involves non-drug interventions using community health workers and lifestyle modification programs, typical medication side effects are not expected. However, participants may experience stress or discomfort related to changes in diet or exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need extra oxygen to breathe properly.

Select...

I have a history of heart or blood vessel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after cessation of intervention or 24 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after cessation of intervention or 24 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after cessation of intervention or 24 months after enrollment for reporting.