Reducing Total Cardiovascular Risk in an Urban Community

NCT00241904 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 335R01HL082638
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Low-density Lipoprotein Cholesterol

  Blood was drawn after a 12 hour fast and low density lipoprotein cholesterol was measured in a standardized lab

  Measured at 1 year

• Systolic Blood Pressure

  Blood pressure measured with automatic blood pressure machine according to the guidelines of the American Heart Association.

  Measured at 1 year

• HbA1c

  Fasting for 12 hour blood sample was measured in standardized lab

  Measured at 1 year

Secondary Outcomes (1)

• Patients' Satisfaction With Care and Health Care Utilization

  Measured at 1 year

Study Arms (2)

Comprehensive Intervention Group

ACTIVE COMPARATOR

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.

Behavioral: Lifestyle Changes; Drug: Antiplatelet Agents; Drug: Beta Blocker; Drug: ACE Inhibitors

Less Intensive Intervention Group

ACTIVE COMPARATOR

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.

Behavioral: Lifestyle Changes

Interventions

Lifestyle Changes BEHAVIORAL

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

Comprehensive Intervention Group; Less Intensive Intervention Group

Antiplatelet Agents DRUG

Aspirin 81 mg q day

Also known as: Bayer, Ecotrin

Comprehensive Intervention Group

Beta Blocker DRUG

Oral medication

Also known as: Metoprolol, Toprol, Atenolol, Propranolol

Comprehensive Intervention Group

ACE Inhibitors DRUG

Oral medications, received 1-2 times per day

Also known as: Lisinopril

Comprehensive Intervention Group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 21953407 DERIVED

MeSH Terms

Conditions

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

Interventions

Platelet Aggregation Inhibitors; Aspirin; Adrenergic beta-Antagonists; Metoprolol; Atenolol; Propranolol; Angiotensin-Converting Enzyme Inhibitors; Lisinopril

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Jerilyn Allen
• Organization: Johns Hopkins University

jallen1@jhu.edu

410-614-4882

Study Officials

• Jerilyn Allen

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 19, 2005
• Study Start: May 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 15, 2017
• Results First Posted: September 15, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)