Reducing Risk Factors in Peripheral Arterial Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary McDermott, Northwestern University
ClinicalTrials.gov Identifier:
NCT00217919
First received: September 19, 2005
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention
Cardiovascular Diseases
Peripheral Vascular Diseases
Behavioral: Health-Counselor Mediated Telephone Counseling Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Risk Factors in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • LDL-C levels [ Time Frame: Measured at baseline and Month 12 ] [ Designated as safety issue: No ]
  • LDL-C lowering knowledge, attitude, and behavior [ Time Frame: Measured at baseline and Month 12 ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: February 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217919

Locations
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
Investigators
Principal Investigator: Mary McDermott, MD Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary McDermott, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00217919     History of Changes
Other Study ID Numbers: 296, R01HL073912, R01 HL73912
Study First Received: September 19, 2005
Last Updated: April 7, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 21, 2015