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Reducing Total Cardiovascular Risk in an Urban Community (COACH)
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Purpose
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.
| Condition | Intervention |
|---|---|
| Cardiovascular Diseases Heart Diseases Coronary Disease Diabetes Mellitus Atherosclerosis Cerebral Arteriosclerosis Hypertension | Behavioral: Lifestyle Changes Drug: Antiplatelet Agents Drug: Beta Blocker Drug: ACE Inhibitors |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Reducing Total Cardiovascular Risk in an Urban Community |
- LDL-C [ Time Frame: Measured at 1 year ]
- Blood pressure [ Time Frame: Measured at 1 year ]
- HbA1c, if diabetic [ Time Frame: Measured at 1 year ]
- Physical activity [ Time Frame: Measured at 1 year ]
- Smoking cessation or reduction, if current tobacco smoker [ Time Frame: Measured at 1 year ]
- Prescribed antiplatelet agents/anticoagulants, if coronary artery disease patient [ Time Frame: Measured at 1 year ]
- Prescribed β- Blockers, if coronary artery disease patient [ Time Frame: Measured at 1 year ]
- Prescribed ACE inhibitors, if post myocardial infarction patient [ Time Frame: Measured at 1 year ]
- Patients' satisfaction with care and health care utilization [ Time Frame: Measured at 1 year ]
| Enrollment: | 525 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive 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.
|
Behavioral: Lifestyle Changes
Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise
Drug: Antiplatelet Agents
Aspirin 81 mg q day
Other Name: Bayer, Ecotrin
Drug: Beta Blocker
Oral medication
Other Names:
Drug: ACE Inhibitors
Oral medications, recieved 1-2 times per day
Other Name: Lisinopril
|
|
Active Comparator: 2
Participants will receive a LI intervention providing feedback on CVD risk factors and guidelines to patients and their physicians.
|
Behavioral: Lifestyle Changes
Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise
Drug: Antiplatelet Agents
Aspirin 81 mg q day
Other Name: Bayer, Ecotrin
Drug: Beta Blocker
Oral medication
Other Names:
Drug: ACE Inhibitors
Oral medications, recieved 1-2 times per day
Other Name: Lisinopril
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00241904
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Jerilyn Allen | Johns Hopkins University School of Nursing |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jerilyn K. Allen, Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00241904 History of Changes |
| Obsolete Identifiers: | NCT00385619 |
| Other Study ID Numbers: |
335 R01HL082638 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | October 17, 2005 |
| Last Updated: | February 24, 2014 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Coronary Artery Disease Arteriosclerosis Intracranial Arteriosclerosis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Arterial Occlusive Diseases Vascular Diseases Myocardial Ischemia Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Platelet Aggregation Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 27, 2017