Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing Total Cardiovascular Risk in an Urban Community (COACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00241904
Recruitment Status : Completed
First Posted : October 19, 2005
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 19, 2005
Results First Submitted Date  ICMJE April 14, 2017
Results First Posted Date  ICMJE September 15, 2017
Last Update Posted Date September 15, 2017
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00241904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Total Cardiovascular Risk in an Urban Community
Official Title  ICMJE Reducing Total Cardiovascular Risk in an Urban Community
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Diabetes Mellitus
  • Atherosclerosis
  • Cerebral Arteriosclerosis
  • Hypertension
Intervention  ICMJE
  • 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:
    • Metoprolol
    • Toprol
    • Atenolol
    • Propranolol
  • Drug: ACE Inhibitors
    Oral medications, received 1-2 times per day
    Other Name: Lisinopril
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Lifestyle Changes
    • Drug: Antiplatelet Agents
    • Drug: Beta Blocker
    • Drug: ACE Inhibitors
  • 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.
    Intervention: Behavioral: Lifestyle Changes
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2014)
525
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00241904
Other Study ID Numbers  ICMJE 335
R01HL082638 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Researchers can contact the PI for access to the data set
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jerilyn Allen Johns Hopkins University School of Nursing
PRS Account Johns Hopkins University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP