Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors

NCT01152957 | Completed DMC

• 2 other identifiers: 200907517R01HL083857-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Heart Disease; Hypertension

Keywords

diabetes; cardiovascular; chronic; Community Health Workers; behavioral; social; diet; exercise; patient; cholesterol; A1C; blood pressure

Outcome Measures

Primary Outcomes (1)

• Glycemic Control

  A1C

  12 months.

Secondary Outcomes (2)

• Blood Pressure

  12 months

• Cholesterol

  12 months

Study Arms (2)

Community Health Worker Model

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

CARIÑO Project BEHAVIORAL

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.

Community Health Worker Model

Enhanced Usual Care BEHAVIORAL

Usual care plus 4 health education brochures

Enhanced Usual Care

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (6)

• 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.

  PMID: 24600243 BACKGROUND

• 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.

  PMID: 25846350 BACKGROUND

• 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.

  PMID: 25913343 BACKGROUND

• 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.

  PMID: 25793266 BACKGROUND

• 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.

  PMID: 28459925 RESULT

• 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.

  PMID: 30024805 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Heart Diseases; Hypertension; Bronchiolitis Obliterans Syndrome; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Vascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Olveen Carrasquillo, MD, MPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: single blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Medicine

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)