Clinical trial NCT00217919: Reducing Risk Factors in Peripheral Arterial Disease
Official title: Reducing Risk Factors in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Peripheral Vascular Diseases
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-22
Enrollment: 355
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: LDL-C levels
timeFrame: Measured at baseline and Month 12
measure: LDL-C lowering knowledge, attitude, and behavior
timeFrame: Measured at baseline and Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: Northwestern University
name: Mary McDermott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.