Reducing Total Cardiovascular Risk in an Urban Community

NCT ID: NCT00241904

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-05-31

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.

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease; Diabetes Mellitus; Atherosclerosis; Cerebral Arteriosclerosis; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Antiplatelet Agents

Intervention Type: DRUG

Aspirin 81 mg q day

Beta Blocker

Intervention Type: DRUG

Oral medication

ACE Inhibitors

Intervention Type: DRUG

Oral medications, received 1-2 times per day

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.

Group Type: ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type: BEHAVIORAL

Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Interventions

Lifestyle Changes

Nutrition counseling, smoking cessation counseling, medication compliance counseling, exercise

Intervention Type: BEHAVIORAL

Antiplatelet Agents

Aspirin 81 mg q day

Intervention Type: DRUG

Beta Blocker

Oral medication

Intervention Type: DRUG

ACE Inhibitors

Oral medications, received 1-2 times per day

Intervention Type: DRUG

Other Intervention Names

Bayer, Ecotrin; Metoprolol; Toprol; Atenolol; Propranolol; Lisinopril

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerilyn Allen

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Nursing

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

Allen JK, Dennison-Himmelfarb CR, Szanton SL, Bone L, Hill MN, Levine DM, West M, Barlow A, Lewis-Boyer L, Donnelly-Strozzo M, Curtis C, Anderson K. Community Outreach and Cardiovascular Health (COACH) Trial: a randomized, controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers. Circ Cardiovasc Qual Outcomes. 2011 Nov 1;4(6):595-602. doi: 10.1161/CIRCOUTCOMES.111.961573. Epub 2011 Sep 27.

Reference Type: DERIVED

PMID: 21953407 (View on PubMed)

Other Identifiers

R01HL082638

Identifier Type: NIH

Identifier Source: secondary_id

View Link

335

Identifier Type: -

Identifier Source: org_study_id

NCT00385619

Identifier Type: -

Identifier Source: nct_alias