CompletedNot Applicable

Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors

United States300 participantsStarted 2010-07

Plain-language summary

A study to examine the effectiveness of a multilevel Community Health Workers intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in Miami.

Who can participate

Age range

35 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients age 35-70 years * Receiving care at ACC clinic (2 visits with a primary care provider in the previous year) * Living in Miami-Dade county (based on zip codes) * Had a hemoglobin A1C done within the past year, with the latest value being \>=8.0 Exclusion Criteria: * Patients whose Primary Doctor believes are not appropriate candidates for participation * Type 1 diabetics (identified by Primary Doctor or those with diabetes diagnosed when under age 25). * Patients who do not self identify as Hispanic * Any life-threatening or extreme medical comorbidity * Having a diabetes diagnosis for less than a year * Planning to move out of the neighborhood during the next year * Participation in any other CVD or diabetes intervention study * Arm circumference of greater than 47 cm (oscillometric cuffs do not give accurate readings)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glycemic Control

Timeframe: 12 months.

Trial details

NCT IDNCT01152957

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Diabetes trials

Who can participate

Age range

35 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.