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

Peripheral Arterial Disease Clinical Trial

Official title:

Promoting Walking in African Americans With Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332058
• Other study ID #: R01HL09890901 - Pilot
• Secondary ID: R01HL0989097R01H
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: July 18, 2012
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Motivational Interviewing
8 possible weeks of motivational interviewing sessions

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Tracie Collins, MD, MPH	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No