Reducing Total Cardiovascular Risk in an Urban Community (COACH)
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| ClinicalTrials.gov Identifier: NCT00241904 |
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Recruitment Status :
Completed
First Posted : October 19, 2005
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Heart Diseases Coronary Disease Diabetes Mellitus Atherosclerosis Cerebral Arteriosclerosis Hypertension | Behavioral: Lifestyle Changes Drug: Antiplatelet Agents Drug: Beta Blocker Drug: ACE Inhibitors | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 525 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Reducing Total Cardiovascular Risk in an Urban Community |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | May 2010 |
| Actual Study Completion Date : | May 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Comprehensive Intervention Group
The NP/CHW intervention focused on behavioral interventions to affect therapeutic lifestyle changes and adherence to medications and appointments as well as the prescription and titration of medications for one year. The NP and CHW worked as a team. The NP oversaw the initial assessment and, in collaboration with the CHW, tailored the intervention plan, conducted the intervention including lifestyle modification counseling and medication titration and prescription, consulted with the physician, and supervised the CHW. Specific algorithms for drug treatment of hyperlipidemia, hypertension (HBP), hyperglycemia, ACE, and β-blocker therapy were developed for this study based on current guidelines and standards of care.
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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, received 1-2 times per day
Other Name: Lisinopril |
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Active Comparator: Less Intensive Intervention Group
Participants will receive usual care from their physicians and a Less Intensive (LI) intervention of feedback on cardiovascular disease (CVD) risk factors and guidelines to patients and their physicians. Patients and their providers in the received the results of baseline lipids, BP, and HbA1c along with the recommended goal levels and a pamphlet on controlling risk factors published by the American Heart Association. In addition, providers received copies of the AHA/ACC Guidelines for Secondary Prevention.
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Behavioral: Lifestyle Changes
Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise |
- Low-density Lipoprotein Cholesterol [ Time Frame: Measured at 1 year ]Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab
- Systolic Blood Pressure [ Time Frame: Measured at 1 year ]Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.
- HbA1c [ Time Frame: Measured at 1 year ]Fasting for 12 hour blood sample was measured in standardized lab
- Patients' Satisfaction With Care and Health Care Utilization [ Time Frame: Measured at 1 year ]Patient satisfaction with care and healthcare utilization was measured with the Patient Assessment for Chronic Illness Care Scale (PACIC). The scores range from 0-5, with 5 being the most satisfied
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241904
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Jerilyn Allen | Johns Hopkins University School of Nursing |
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00241904 |
| Obsolete Identifiers: | NCT00385619 |
| Other Study ID Numbers: |
335 R01HL082638 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 19, 2005 Key Record Dates |
| Results First Posted: | September 15, 2017 |
| Last Update Posted: | September 15, 2017 |
| Last Verified: | August 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Researchers can contact the PI for access to the data set |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Intracranial Arteriosclerosis Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Arteriosclerosis Vascular Diseases Arterial Occlusive Diseases Myocardial Ischemia Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Propranolol |
Metoprolol Atenolol Lisinopril Platelet Aggregation Inhibitors Adrenergic beta-Antagonists Angiotensin-Converting Enzyme Inhibitors Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents Sympatholytics |