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

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

The investigators are conducting a pilot study for a clinical research trial to establish the feasibility and acceptability of the intervention and the most effective recruitment strategies prior to the full study.

Key facts

Study ID

NCT01332058

Run by

Tracie Collins, MD, MPH

People needed

2

Starts

2011-03-01

Expected to finish

2011-05-01

Last updated by the study team

2012-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African American (determined by self-report)
• Lived most of their life in the United States
• Resting ABI <0.95
• 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)
• 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
• Use of supplemental oxygen
• Myocardial infarction within the preceding 3 months
• Resting blood pressure > 200/110 mmHg
• Exercise-induced coronary ischemic symptoms, or exercise-induced ST depression > 2.0 mm
• 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).

Where it is running

• University of Kansas Medical Center — Wichita, Kansas, United States

Full record on ClinicalTrials.gov

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