Clinical trial NCT01152957: Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Heart Disease
Hypertension
Keywords: diabetes
cardiovascular
chronic
Community Health Workers
behavioral
social
diet
exercise
patient
cholesterol
A1C
blood pressure
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility 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)

Primary outcomes:
measure: Glycemic Control
timeFrame: 12 months.
Secondary outcomes:
measure: Blood Pressure
timeFrame: 12 months
measure: Cholesterol
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Olveen Carrasquillo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrasquillo O, Patberg E, Alonzo Y, Li H, Kenya S. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes. Int J Gen Med. 2014 Feb 27;7:115-26. doi: 10.2147/IJGM.S56250. eCollection 2014.
citation: Kenya S, Lebron CN, Chang AY, Li H, Alonzo YA, Carrasquillo O. A profile of Latinos with poorly controlled diabetes in South Florida. J Community Hosp Intern Med Perspect. 2015 Apr 1;5(2):26586. doi: 10.3402/jchimp.v5.26586. eCollection 2015.
citation: Lebron CN, Reyes-Arrechea E, Castillo A, Carrasquillo O, Kenya S. Tales from the Miami Healthy Heart Initiative: the experiences of two community health workers. J Health Care Poor Underserved. 2015 May;26(2):453-62. doi: 10.1353/hpu.2015.0033.
citation: Chang A, Kenya S, Ilangovan K, Li H, Koru-Sengul T, Alonzo Y, Carrasquillo O. Is greater acculturation associated with an increased prevalence of cardiovascular risk factors among Latinos in South Florida? Med Care. 2015 May;53(5):417-22. doi: 10.1097/MLR.0000000000000337.
citation: Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S. Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):948-954. doi: 10.1001/jamainternmed.2017.0926.
citation: Chang A, Patberg E, Cueto V, Li H, Singh B, Kenya S, Alonzo Y, Carrasquillo O. Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1249-1251. doi: 10.2105/AJPH.2018.304542. Epub 2018 Jul 19.