Reducing Total Cardiovascular Risk in an Urban Community

Hypertension Clinical Trial

— COACH  

Official title:

Reducing Total Cardiovascular Risk in an Urban Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241904
• Other study ID #: 335
• Secondary ID: R01HL082638
• Status: Completed
• Phase: N/A
• First received: October 17, 2005
• Last updated: February 24, 2014
• Start date: May 2006
• Est. completion date: May 2010

Study information

• Verified date: February 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00385619

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Currently receiving medical care at Johns Hopkins University

• African American or Caucasian and have diagnosed CVD, defined as a prior myocardial infarction, revascularization procedure for coronary disease, ischemic heart disease, stroke, or have diagnosed type 2 diabetes and not receiving any therapy

• Have either no LDL-C in their medical record during the 12 months prior to study entry or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering pharmacotherapy

• Have either no blood pressure recorded in their medical record during the 12 months prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if the participant is diabetic or has renal insufficiency

• If the participant is diabetic he or she has to either have no HbA1c recorded during the 12 months prior to study entry or HbA1c of 7 percent or greater

Exclusion criteria:

• A serious life-threatening noncardiac comorbidity with a life expectancy of less than 5 years

• A serious physician-recorded psychiatric morbidity that would interfere with the study

• Sufficient neurological impairment that would interfere with the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Cardiovascular Diseases
• Cerebral Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Diseases
• Hypertension
• Intracranial Arteriosclerosis

Intervention

Behavioral:
• Lifestyle Changes
Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Drug:
• Antiplatelet Agents
Aspirin 81 mg q day
• Beta Blocker
Oral medication
• ACE Inhibitors
Oral medications, recieved 1-2 times per day

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C		Measured at 1 year	No
Primary	Blood pressure		Measured at 1 year	No
Primary	HbA1c, if diabetic		Measured at 1 year	No
Primary	Physical activity		Measured at 1 year	No
Primary	Smoking cessation or reduction, if current tobacco smoker		Measured at 1 year	No
Primary	Prescribed antiplatelet agents/anticoagulants, if coronary artery disease patient		Measured at 1 year	No
Primary	Prescribed ß- Blockers, if coronary artery disease patient		Measured at 1 year	No
Primary	Prescribed ACE inhibitors, if post myocardial infarction patient		Measured at 1 year	No
Secondary	Patients' satisfaction with care and health care utilization		Measured at 1 year	No