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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


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
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