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Behavioral Intervention

Church-based Health Intervention for Cardiovascular Disease (CHERISH Trial)

N/A

Recruiting

Research Sponsored by Tulane University

Eligibility Criteria Checklist

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

Must have

Black or African American men or women aged ≥40 years

Be older than 18 years old

Must not have

No prior hospitalization in the last 3 months for chronic heart failure or heart attack

No stage-5 chronic kidney disease requiring chronic dialysis, or transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, 12, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the impact of two approaches to reduce CVD disparities in Black communities in Louisiana. One is a CHW-led multifaceted intervention, the other is a group-based education strategy.

Who is the study for?

The CHERISH study is for Black or African American adults aged 40 and over who are connected to participating churches in New Orleans. They must have at least four of these risk factors: smoking, obesity, low physical activity, poor diet, high cholesterol, high blood pressure, or elevated blood sugar. Those with recent severe health issues like cancer treatment or heart failure aren't eligible.

What is being tested?

This trial tests two strategies to improve cardiovascular health in the Black community using guidelines from the ACC/AHA. One strategy involves a community health worker leading various interventions; the other uses group education. The study will last 18 months and measure how well each method works.

What are the potential side effects?

Since this trial focuses on lifestyle changes and education rather than medication, side effects are not typical as seen with drug trials. However, participants may experience discomfort adjusting to new diets or exercise routines.

Eligibility Criteria

Inclusion Criteria

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

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I am a Black or African American person aged 40 or older.

Exclusion Criteria

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

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I haven't been hospitalized for heart failure or a heart attack in the last 3 months.

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I do not have advanced kidney disease requiring dialysis or a transplant.

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I do not need chemotherapy or radiation for any cancer right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, 12, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, 12, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score

Fidelity summary score

Secondary study objectives

Acceptability

Adoption (church)

Adoption (provider)

+19 more

Other study objectives

Difference in medication adherence

Difference in proportion of those receiving statin treatment who are eligible

Difference in proportion of those who cease smoking of those who are current smokers at baseline

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group-based Education StrategyExperimental Treatment1 Intervention

Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP.

Group II: Community health worker-led implementation strategy:Experimental Treatment1 Intervention

Individual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP.

0 / 4Eligibility criteria met