Reducing Risk Factors in Peripheral Arterial Disease

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Peripheral Vascular Diseases
• Intervention / Treatment: Behavioral: Health-Counselor Mediated Telephone Counseling Intervention

Detailed Description

BACKGROUND:

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

DESIGN NARRATIVE:

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
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Feinberg School of Medicine
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2; Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL-C levels	Measured at baseline and Month 12
LDL-C lowering knowledge, attitude, and behavior	Measured at baseline and Month 12

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Mary McDermott, MD, Northwestern University

Publications and helpful links

General Publications

• Pagoto SL, McDermott MM, Reed G, Greenland P, Mazor KM, Ockene JK, Whited M, Schneider K, Appelhans B, Leung K, Merriam P, Ockene I. Can attention control conditions have detrimental effects on behavioral medicine randomized trials? Psychosom Med. 2013 Feb;75(2):137-43. doi: 10.1097/PSY.0b013e3182765dd2. Epub 2012 Nov 28.
• McDermott MM, Greenland P, Reed G, Mazor KM, Merriam PA, Graff R, Tao H, Pagoto S, Manheim L, Kibbe MR, Ockene IS. Gender differences in cholesterol-lowering medication prescribing in peripheral artery disease. Vasc Med. 2011 Dec;16(6):428-35. doi: 10.1177/1358863X11425879.
• McDermott MM, Reed G, Greenland P, Mazor KM, Pagoto S, Ockene JK, Graff R, Merriam PA, Leung K, Manheim L, Kibbe MR, Olendzki B, Pearce WH, Ockene IS. Activating peripheral arterial disease patients to reduce cholesterol: a randomized trial. Am J Med. 2011 Jun;124(6):557-65. doi: 10.1016/j.amjmed.2010.11.032.
• McDermott MM, Mazor KM, Reed G, Pagoto S, Graff R, Merriam P, Kibbe M, Greenland P, Ockene J, Olendzki B, Huimin Tao, Ockene I. Attitudes and behavior of peripheral arterial disease patients toward influencing their physician's prescription of cholesterol-lowering medication. Vasc Med. 2010 Apr;15(2):83-90. doi: 10.1177/1358863X09353653. Epub 2010 Jan 29.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 21, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 7, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Cardiovascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 296; R01HL073912 (U.S. NIH Grant/Contract)