Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 8:48 AM
Study NCT ID:
NCT01152957
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miami Healthy Heart Initiative a Behavioral Study on Cardiovascular Risk Factors
Sponsor:
University of Miami
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MHHI
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 7R01HL083857-02 | NIH | None | https://reporter.nih.gov/quic… | View |