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Community health workers take on heart disease prevention in cleveland

NCT ID NCT05918380

Prevention Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a program called PAL2, delivered by community health workers, can help Black adults aged 40 to 75 lower their risk of heart disease. Participants live in the Cleveland area and have at least two risk factors, such as high blood pressure, high cholesterol, or elevated blood sugar. The program includes monthly check-ins, screening for social needs like food or housing, and education on managing blood pressure and lifestyle. The goal is to see if more people can reach healthy targets for blood pressure, blood sugar, and cholesterol.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PAL2, a community health worker-led program that provides personalized lifestyle coaching, social needs screening, and education on blood pressure and heart health
What this could lead to
If it works, this could point toward a practical, community-based way to reduce heart disease risk and narrow health disparities in Black communities.
What could go wrong
The trial is early and focuses on prevention, so it may not show a clear benefit. Success depends on participants staying engaged with the program over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. BMI≥30 mg/dL 2. History of smoking 3. Elevated blood pressure defined as SBP\>140 or DBP\>80 mmHg 4. HbA1c≥5.7% 5. LDL≥130 5. Able to complete a coronary artery calcium score test (CAC) 6. Willing and able to consent 7. Willing to have a UH provider and UH care 8. 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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary heart disease

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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