Reducing Risk Factors in Peripheral Arterial Disease

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. Identifier: NCT00217919
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 9, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mary McDermott, Northwestern University

Brief Summary:
The purpose of this study is to compare a health-counselor mediated telephone counseling intervention to usual care to reduce low density lipoprotein cholesterol (LDL-C) levels in patients with peripheral arterial disease (PAD).

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Peripheral Vascular Diseases Behavioral: Health-Counselor Mediated Telephone Counseling Intervention Not Applicable

Detailed Description:


Patients with PAD have a 3- to 4-fold higher risk of cardiovascular morbidity and mortality compared to patients without PAD. Risk of future cardiovascular events is comparable between patients with PAD and coronary artery disease (CAD). While improved atherosclerotic risk factor treatment has reduced cardiovascular morbidity and mortality in patients with CAD, such treatment in patients with PAD remains suboptimal. Intensity of cholesterol-lowering therapy, specifically, is significantly poorer in patients with PAD as compared to CAD. Data show that fully 69 percent of patients with PAD from a non-invasive vascular laboratory in Chicago did not have the recommended LDL-C level of less than 100 mg/dl. Our data from a national survey indicate that physicians believe atherosclerotic risk factor treatment is less important for patients with PAD than for patients with CAD. Our data also show that many patients with PAD are unaware of their increased risk of cardiovascular events and under-appreciate the importance of risk factor treatment in PAD. These findings likely contribute to risk factor under-treatment in patients with PAD. Clinical trials such as this are needed to demonstrate whether PAD risk factors can be reduced. If effective, this clinical trial will also encourage clinicians to adopt the proven intervention to lower cardiovascular risks in patients with PAD


This randomized, controlled clinical trial will test the ability of a health-counselor mediated telephone counseling intervention as compared to usual care to reduce LDL-C levels in patients with PAD. The study involves patients with PAD who have LDL-C levels greater than 100 mg/dl at baseline identified from non-invasive vascular laboratories in Chicago, IL and Worcester, MA. For their primary specific aim, the investigators hypothesize that subjects randomized to the intervention condition will achieve a reduction in LDL-C of at least 11.1 mg/dl greater than the reduction in LDL-C for subjects randomized to the usual care condition at 12-month follow-up. In their secondary aim, they will determine whether the telephone counseling intervention increases the proportion of PAD patients with LDL-C less than 100 mg/dl as compared to the usual care condition at 12-month follow-up. To identify the mediators of the intervention, in their exploratory aims they will determine whether patients in the intervention condition achieve greater increases (improvement) in specific behavioral and knowledge and attitude mediators that will be targeted by the intervention, as compared to patients in the usual care condition.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Risk Factors in Peripheral Arterial Disease
Study Start Date : February 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Health-Counselor Mediated Telephone Counseling Intervention
Behavioral: Health-Counselor Mediated Telephone Counseling Intervention

A trained health counselor will conduct the TC sessions, which will occur every 6 weeks (total 8 calls). We expect the initial call to last 30 minutes, with subsequent calls lasting 20 minutes. Our intervention for our primary outcome of LDL-C lowering is expected to take most of this time. We will spend approximately 5 minutes addressing physical activity at the end of each session, using methods similar to those in our pilot TC study.

We will use patient-centered counseling to promote adherence to lipid-lowering medication and LDL-C lowering diet. The intervention will also activate patients to discuss initiation or dose increase of lipid-lowering drugs with their physicians. While the focus of our intervention will be on LDL-C lowering, the TC intervention will also devote approximately 5 minutes of the typical 20 minute call to increasing physical activity.

No Intervention: 2
Usual care

Primary Outcome Measures :
  1. LDL-C levels [ Time Frame: Measured at baseline and Month 12 ]
  2. LDL-C lowering knowledge, attitude, and behavior [ Time Frame: Measured at baseline and Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Life expectancy greater than 1 year
  • Has a telephone
  • English-speaking
  • Willing to use acceptable methods of contraception
  • Have a primary care physician

Exclusion Criteria:

  • Currently undergoing cancer treatment or plans to begin treatment
  • Psychiatric illness or cognitive impairment
  • Intolerance to two or more cholesterol-lowering drugs
  • Plans to move out of the area within one year of study entry
  • Wheel-chair bound or unable to walk outside of home
  • Below- or above-knee amputation
  • Unstable angina
  • Current foot ulcers
  • LDL-C less than 70 mg/dl at baseline
  • Debilitating chronic obstructive lung disease
  • Major surgery within 3 months prior to study entry or plans to undergo major surgery within 1 year of study entry
  • Current participation in another clinical trial. A six month period will be required after completing another clinical trial before an individual can become eligible for the current trial.
  • Ischemic rest pain
  • Pregnancy or plan to become pregnant

Information from the National Library of Medicine

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 identifier (NCT number): NCT00217919

United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Mary McDermott, MD Northwestern University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mary McDermott, Principal Investigator, Northwestern University Identifier: NCT00217919     History of Changes
Other Study ID Numbers: 296
R01HL073912 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases