Status:
COMPLETED
Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes
Heart Disease
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief 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.
Detailed Description
Disparities in the epidemiology of cardiovascular disease (CVD) risk factors among Latinos have been extensively described; however, traditional medical models of CVD risk reduction have not been very...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01152957
Start Date
July 1 2010
End Date
November 1 2013
Last Update
October 17 2018
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136