Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT00241904
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2005-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reducing Total Cardiovascular Risk in an Urban Community
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Reducing Total Cardiovascular Risk in an Urban Community
Status:
COMPLETED
Status Verified Date:
2017-08
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:
COACH
Brief Summary:
PLEASE NOTE: THIS STUDY IS ONLY ENROLLING PATIENTS CURRENTLY BEING TREATED AT BELAIR-EDISON FAMILY HEALTH CENTER.
The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.
The purpose of this study is to compare the clinical effectiveness and cost effectiveness of two cardiovascular risk reduction programs - a comprehensive intensive (Cl) intervention with a less intensive (LI) intervention - in African American, and white low-income patients with known excessive cardiovascular disease risk.
Detailed Description:
BACKGROUND:
The study is based on the premise that a community-based participatory research partnership model, using a team of an advanced practice nurse case manager, community health worker (CHW), and physician can be translated into urban community clinics and improve the quality of care and reduce disparities in cardiovascular health in minority and other underserved populations. Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of CVD risk-reducing practices remains poor. In spite of the known benefit of lowering low-density lipoprotein cholesterol (LDL-C) levels below 100 mg/dl in persons with existing heart disease, as many as 50 to 70 percent of eligible CVD patients are not placed on lipid-lowering therapy by their providers and from 20 to 80 percent of patients do not achieve the goals of therapy. The benefits of controlling high blood pressure (HBP) are well established, yet national rates of HBP control remain at only 31 percent despite decades of provider and patient education. In addition, it is well established that control of glycemia, hyperlipidemia, and blood pressure reduce the risk of vascular complications in people with diabetes, 75 percent of whom die from some form of heart or blood vessel disease. This randomized trial will compare the clinical effectiveness and cost effectiveness of a CI intervention with a LI intervention in African American, and white low-income patients with known excessive CVD risk.
DESIGN NARRATIVE:
Eligible patients with CVD or type 2 diabetes will be randomly selected from two urban federally funded community clinics and randomly assigned to receive either 1) a Cl intervention delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes and medication adherence as well as the prescription and titration of medications or 2) a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians. Outcomes will be measured at baseline and one and two years. It is hypothesized that a higher proportion of patients in the Cl intervention group will achieve the treatment goals for lipid, blood pressure, and diabetes management, lifestyle behaviors and utilization of antiplatelet agent, beta blocker, and angiotensin converting enzyme (ACE) inhibitor therapies and that the Cl intervention will be cost-effective. Secondary outcomes include assessment of the impact of the Cl intervention model on patients' satisfaction with care and health care utilization. The increase in the percentage of high-risk women and men who receive recommended secondary prevention therapies and achieve goal levels could potentially result in a marked decrement in annual CVD mortality and health disparities if applied within primary care settings to populations with the characteristics of the target groups for this study.
The study is based on the premise that a community-based participatory research partnership model, using a team of an advanced practice nurse case manager, community health worker (CHW), and physician can be translated into urban community clinics and improve the quality of care and reduce disparities in cardiovascular health in minority and other underserved populations. Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of CVD risk-reducing practices remains poor. In spite of the known benefit of lowering low-density lipoprotein cholesterol (LDL-C) levels below 100 mg/dl in persons with existing heart disease, as many as 50 to 70 percent of eligible CVD patients are not placed on lipid-lowering therapy by their providers and from 20 to 80 percent of patients do not achieve the goals of therapy. The benefits of controlling high blood pressure (HBP) are well established, yet national rates of HBP control remain at only 31 percent despite decades of provider and patient education. In addition, it is well established that control of glycemia, hyperlipidemia, and blood pressure reduce the risk of vascular complications in people with diabetes, 75 percent of whom die from some form of heart or blood vessel disease. This randomized trial will compare the clinical effectiveness and cost effectiveness of a CI intervention with a LI intervention in African American, and white low-income patients with known excessive CVD risk.
DESIGN NARRATIVE:
Eligible patients with CVD or type 2 diabetes will be randomly selected from two urban federally funded community clinics and randomly assigned to receive either 1) a Cl intervention delivered by a nurse practitioner, a CHW, and the patient's physician, focusing on behavioral interventions to affect therapeutic lifestyle changes and medication adherence as well as the prescription and titration of medications or 2) a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians. Outcomes will be measured at baseline and one and two years. It is hypothesized that a higher proportion of patients in the Cl intervention group will achieve the treatment goals for lipid, blood pressure, and diabetes management, lifestyle behaviors and utilization of antiplatelet agent, beta blocker, and angiotensin converting enzyme (ACE) inhibitor therapies and that the Cl intervention will be cost-effective. Secondary outcomes include assessment of the impact of the Cl intervention model on patients' satisfaction with care and health care utilization. The increase in the percentage of high-risk women and men who receive recommended secondary prevention therapies and achieve goal levels could potentially result in a marked decrement in annual CVD mortality and health disparities if applied within primary care settings to populations with the characteristics of the target groups for this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| R01HL082638 | NIH | None | https://reporter.nih.gov/quic… | View |