Clinical trial NCT01332058: Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD) Pilot
Official title: Promoting Walking in African Americans With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
Walking
Motivational Interviewing
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-04-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: The eight week pilot will be conducted to establish the feasibility of implementing motivational interviewing as a means to counsel African Americans with peripheral arterial disease (PAD) to increase their walking. Additionally, we will determine the acceptance of culturally sensitive print material on managing PAD. Finally, we will utilize the pilot to develop best practice methods for successfully carrying out the full study.

Eligibility criteria: Inclusion Criteria:

* African American (determined by self-report)
* Lived most of their life in the United States
* Resting ABI \<0.95
* English Speaking
* Has a telephone

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change from baseline to eight weeks in 6 minute walk test
timeFrame: 8 weeks
Secondary outcomes:
measure: Baseline six minute walk test
timeFrame: baseline
measure: Baseline 7 day physical activity
timeFrame: baseline
measure: Change from baseline to eight weeks 7 day physical activity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Wichita
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Tracie C Collins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: