Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors

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 effective in Latinos. One promising strategy is the use of community-based
community health workers (CHWs). CHWs have long been used in Latin-America as an integral
part of their health care delivery system. Further, preliminary data from our prior pilot
diabetes self-management CHW program have shown improvements in lipids. However, because of a
lack of effectiveness data from studies using rigorous experimental designs, the adoption of
the CHW model has been quite limited both locally and nationally. In MHHI, our goal is to
examine the effectiveness of a CHW intervention in CVD risk reduction among Latinos.

The investigators propose to examine the effectiveness of a multilevel CHW intervention as an
adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos Miami.
The UM Jay Weiss Center which has substantial experience in Community Health Worker Program
will take the lead role in the development and implementation intervention of the CHW
program.

The study design is a randomized controlled trial (RCT) of 300 Latino patients ages 35-70
with poorly controlled diabetes (AIC >=8.0) followed at the Ambulatory Care Clinic (ACC) of
Jackson Memorial Hospital (JMH).

Primary Objective: To determine if the CHW intervention results in lowering of CVD risk
factors including blood pressure, LDL cholesterol, and diabetes control (AIC) as measured by
the Total Framingham Risk Score (FRS).

Secondary Objectives: To determine if the CHW intervention results in improvements in the
following putative mechanisms that may influence the FRS:

1. Medication adherence (measured by validated instruments)

2. Improvements in diet and exercise (as measured by validated instruments);

Hypotheses: Among patients receiving care at the ACC we hypothesize that as compared to those
in enhanced usual care, patients randomized to the CHW intervention at 18 months will have:

1. Greater reductions in blood pressure and low density lipoprotein (LDL)

2. Improved glycemic control

3. Greater rates of medication adherence (taking >80% of specified medication doses)

4. Increases in physical activity (kcal/week)

5. Increases in mean number of daily vegetables consumed

The CHW intervention will involve 4 or more (as required) home visits, 10 group sessions, an
10 follow-up phone calls per subject over a 12-month time period. The primary outcome is a
HgA1C; secondary outcomes include LDL levels, and systolic and diastolic blood pressure.
Baseline and follow-up data on medication adherence, medication intensification, diet and
exercise will also be collected.

The control group will continue to receive usual care from their primary care physician. We
will enhance the usual care that these patients receive by providing them with three sets of
educational materials published by the NIH.

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)