Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD)

NCT01321086 | Completed

• 1 other identifier: 7R01HL098909-03
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators are conducting a clinical research trial to determine the role of motivational interviewing (MI) on promoting home-based walking therapy to improve walking ability in African Americans with peripheral arterial disease (PAD). African Americans are more than two times as likely as non-Hispanic whites to suffer from PAD. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. The investigators will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function. In order to motivate the participants to walk, the investigators included two different intervention strategies: MI and patient-centered counseling for exercise (PACE). The investigators hypothesize that participants randomized to the MI arm will have a greater increase in their walking distance, compared to those receiving Patient-Centered Assessment and Counseling for Exercise (PACE) and the control group.

Conditions

Peripheral Arterial Disease

Keywords

PAD

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test

  Distance walked in 6 minutes

  6 months

Secondary Outcomes (19)

• Short Physical Performance Battery (SPPB)

  Baseline

• Blood work for glucose and lipid levels

  Baseline

• Adherence to Physical Activity

  Baseline

• Ankle-Brachial Index (ABI)

  Baseline

• Quality of Life

  Baseline

Study Arms (3)

Motivational Interviewing

ACTIVE COMPARATOR

Motivational Interviewing (MI) is an effective counseling method in individuals who are less ready to change their behavior. 9 MI sessions will be conducted over the course of the six month intervention.

Behavioral: Motivational Interviewing

PACE

ACTIVE COMPARATOR

Patient-centered Assessment and Counseling for Exercise (PACE) is a protocol that targets known modifiable determinants of behavior change to motivate participants to increase their physical activity (walking).

Behavioral: PACE

Control

NO INTERVENTION

Interventions

Motivational Interviewing BEHAVIORAL

9 sessions of MI from baseline to six months

Motivational Interviewing

PACE BEHAVIORAL

9 sessions of PACE delivered from baseline to six months

PACE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• African American (determined by self-report)
• Lived most of their life in the United States
• Resting ABI \<0.995
• English Speaking
• Has a telephone

You may not qualify if:

• Currently walking for exercise at least 5 days per week (i.e., a PACE score ranging from 5-8); the rationale is that a person who is currently walking for at least 5 days per week is already sufficiently active and therefore not a member of the target population for our motivational home-based walking intervention.
• Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
• Rest pain with ABI \<0.4 and non-palpable femoral pulses without prior evaluation by a vascular surgeon, given the need for evaluation for the role of more invasive therapy prior to recommending walking therapy
• Leg revascularization within 3 months of enrollment or plans for revascularization during the study period; the rationale is that post intervention recovery and potential complications are likely to limit the patient's ability to adhere to the study protocol.
• Use of supplemental oxygen; the rationale for this is concern for participant safety and potential limited ability to participate in the study secondary to breathing difficulty.
• Myocardial infarction within the preceding 3 months; the rationale for this is participant safety and the potential risk for complications and/or the need for supervised cardiac rehabilitation following the event.
• Resting blood pressure \> 200/110 mmHg; the rationale for this is participant safety, as blood pressure may further increase during exercise and increase risk for a cerebrovascular event or myocardial infarction.
• Exercise-induced coronary ischemic symptoms, or exercise-induced ST depression \> 2.0 mm; the rationale for this is participant safety and the need for further cardiac evaluation prior to involvement in walking therapy (American College of Cardiology/American Heart Association, 2006).
• Inability to walk for 2 minutes; the rationale being that people who cannot walk for 2 minutes would not be able to complete the necessary submaximal treadmill test, which is used to screen for coronary ischemic symptoms. We will also exclude anyone who can walk for 20 minutes or more during the submaximal treadmill test. Anyone who can complete the submaximal test would not have significant walking impairment and would not get that much out of the study. Short Physical Performance Battery score of 10 or higher as such persons do not have a clinically significant impairment in mobility; therefore, we will exclude anyone who scores a 10 or higher (out of a maximum of 12 points).

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Clinical and Translational Science Unit

Fairway, Kansas, 66205, United States

Location

KU School of Medicine-Wichita

Wichita, Kansas, 67214, United States

Location

Related Publications (2)

• Collins TC, Lu L, Ahluwalia JS, Nollen NL, Sirard J, Marcotte R, Post S, Zackula R. Efficacy of Community-Based Exercise Therapy Among African American Patients With Peripheral Artery Disease: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e187959. doi: 10.1001/jamanetworkopen.2018.7959.

  PMID: 30768192 DERIVED

• Love B, Nwachokor D, Collins T. Recruiting African Americans with peripheral artery disease for a behavioral intervention trial. Vasc Med. 2016 Aug;21(4):345-51. doi: 10.1177/1358863X16628646. Epub 2016 Feb 18.

  PMID: 26893320 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tracie C Collins, MD, MPH

  KU School of Medicine-Wichita

  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: Preventive Medicine and Public Health Chair

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: March 23, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

US (2)