Reducing Risk Factors in Peripheral Arterial Disease

NCT00217919 | Completed DMC

• 2 other identifiers: 296R01HL073912
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 2

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).

Conditions

Cardiovascular Diseases; Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• LDL-C levels

  Measured at baseline and Month 12

• LDL-C lowering knowledge, attitude, and behavior

  Measured at baseline and Month 12

Study Arms (2)

1

EXPERIMENTAL

Health-Counselor Mediated Telephone Counseling Intervention

Behavioral: Health-Counselor Mediated Telephone Counseling Intervention

2

NO INTERVENTION

Usual care

Interventions

Health-Counselor Mediated Telephone Counseling Intervention BEHAVIORAL

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.

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (4)

• 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.

  PMID: 23197844 DERIVED

• 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.

  PMID: 22128042 DERIVED

• 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.

  PMID: 21605733 DERIVED

• 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.

  PMID: 20118170 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Mary McDermott, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (2)