Miami Healthy Heart Initiative (MHHI) a Randomized Study of Behavioral Risk Factors for Cardiovascular Disease in Latino and Hispanic Patients With Poorly Controlled Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Glycemic Control
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
single blinded
入排标准
- 年龄范围
- 35 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: CARIÑO Project (Behavioral)
Enhanced Usual Care
Usual Care and mailing of 4 health education brochures over the year.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Glycemic Control
时间窗: 12 months.
A1C
次要结局
- Blood Pressure(12 months)
- Cholesterol(12 months)
研究者
Olveen Carrasquillo
Chief, Division of General Medicine
University of Miami
