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

Promoting Walking in African Americans With Peripheral Arterial Disease

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Motivational Interviewing

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67214
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing (MI)	Behavioral: Motivational Interviewing; 8 possible weeks of motivational interviewing sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to eight weeks in 6 minute walk test	The participant will walk as far as possible for 6 minutes in a marked corridor. They will be permitted to slow down, stop, and to rest as necessary, but the time will continue to run. They will be given standardized encouragement at each minute and their ending point will be marked with tape. The laps will be counted and the total distance in feet will be recorded. The onset of claudication, number of times the participant needed to stop, and rate of perceived exertion will be recorded throughout the test.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline six minute walk test	The participant will walk as far as possible for 6 minutes in a marked corridor. They will be permitted to slow down, stop, and to rest as necessary, but the time will continue to run. They will be given standardized encouragement at each minute and their ending point will be marked with tape. The laps will be counted and the total distance in feet will be recorded. The onset of claudication, number of times the participant needed to stop, and rate of perceived exertion will be recorded throughout the test.	baseline
Baseline 7 day physical activity	Each participant will wear an accelerometer for one week at baseline to collect their current level physical activity. The accelerometers will collect movement in x, y, and z axis as well as total steps. They will be asked to put the accelerometer on first thing in the morning and take it right before bed.	baseline
Change from baseline to eight weeks 7 day physical activity	Each participant will wear an accelerometer for one week at baseline to collect their current level physical activity. The accelerometers will collect movement in x, y, and z axis as well as total steps. They will be asked to put the accelerometer on first thing in the morning and take it right before bed.	8 weeks

Collaborators and Investigators

• Sponsor: Tracie Collins, MD, MPH
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Tracie C Collins, MD, MPH, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): July 20, 2012
• Last Update Submitted That Met QC Criteria: July 18, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Peripheral arterial disease; Walking
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: R01HL09890901 - Pilot; 7R01HL098909-03 (U.S. NIH Grant/Contract); R01HL098909 (U.S. NIH Grant/Contract)