Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors
Condition: Diabetes; Heart Disease; Hypertension
MeSH terms: Heart Diseases
Study type: Interventional

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 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.
    

Intervention name(s): CARIÑO Project; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Care Attention Resources Information Nutrition & Optimism Project (CARIÑO) is a CHW intervention that will involve 4 or more (as required) home visits, 10 group sessions, and 10 follow-up phone calls per subject over a 12-month period. The primary outcome is lower HgA1C levels. The secondary outcomes are to lower LDL levels, and systolic and diastolic blood pressure, medication adherence and improved diet and exercise. CARIÑO Project will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals.; Usual care plus 4 health education brochures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: diabetes; cardiovascular; chronic; Community Health Workers; behavioral; social; diet; exercise; patient; cholesterol; A1C; blood pressure