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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Olveen Carrasquillo, University of Miami
ClinicalTrials.gov Identifier:
NCT01152957
First received: June 28, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention
Diabetes
Heart Disease
Hypertension
Behavioral: CARIÑO Project

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • To determine if the Community Health Worker intervention results in lowering of CVD risk factors including blood pressure, cholesterol, and diabetes (A1C) measured by the Total Framingham Risk Score (FRS). [ Time Frame: Participants will be followed for the duration of 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if the Community Health Worker intervention results in improvements in the following putative mechanisms that may influence the FRS: Medication adherence and improvements in diet and exercise. [ Time Frame: Participants will be followed for the duration of 12 months ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

We 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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152957

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Olveen Carrasquillo, MD, MPH University of Miami
  More Information

No publications provided

Responsible Party: Olveen Carrasquillo, Chief, Division of General Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT01152957     History of Changes
Other Study ID Numbers: 20090751, 7R01HL083857-02
Study First Received: June 28, 2010
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
diabetes
cardiovascular
chronic
Community Health Workers
behavioral
social
diet
exercise
patient
cholesterol
A1C
glucose

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014