MHHI: Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors

Sponsor

University of Miami (Other)

Overall Status

Completed

CT.gov ID

NCT01152957

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

300

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Heart Disease Hypertension	Behavioral: CARIÑO Project Behavioral: Enhanced Usual Care	N/A

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:

Medication adherence (measured by validated instruments)
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:

Greater reductions in blood pressure and low density lipoprotein (LDL)
Improved glycemic control
Greater rates of medication adherence (taking >80% of specified medication doses)
Increases in physical activity (kcal/week)
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

single blinded

Primary Purpose:

Supportive Care

Official Title:

Miami Healthy Heart Initiative (MHHI) a Randomized Study of Behavioral Risk Factors for Cardiovascular Disease in Latino and Hispanic Patients With Poorly Controlled Diabetes

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Community Health Worker Model Care, Attention, Resources, Information, Nutrition and Optimism Project (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.	Behavioral: CARIÑO Project 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.
Active Comparator: Enhanced Usual Care Usual Care and mailing of 4 health education brochures over the year.	Behavioral: Enhanced Usual Care Usual care plus 4 health education brochures

Arm

Intervention/Treatment

Experimental: Community Health Worker Model

Care, Attention, Resources, Information, Nutrition and Optimism Project (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.

Behavioral: CARIÑO Project

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.

Active Comparator: Enhanced Usual Care

Usual Care and mailing of 4 health education brochures over the year.

Behavioral: Enhanced Usual Care

Usual care plus 4 health education brochures

Outcome Measures

Primary Outcome Measures

Glycemic Control [12 months.]
A1C

Secondary Outcome Measures

Blood Pressure [12 months]
SBP
Cholesterol [12 months]
LDL

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)