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CompletedNCT01332058Updated Jul 20, 2012

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

An interventional study of Motivational Interviewing in Peripheral Arterial Disease, sponsored by Tracie Collins, MD, MPH. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by Tracie Collins, MD, MPH · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Peripheral arterial disease
  • Walking
  • Motivational Interviewing
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 2 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

This is the only study on the registry with Tracie Collins, MD, MPH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Motivational Interviewing (MI)

    Behavioral: Motivational Interviewing

Interventions

  • BehavioralMotivational Interviewing

    8 possible weeks of motivational interviewing sessions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: baseline

  3. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • University of Kansas Medical Center
    Wichita, Kansas 67214, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01332058
Lead sponsor
Tracie Collins, MD, MPH
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Tracie Collins, MD, MPH (Preventive Medicine and Public Health Chair, University of Kansas Medical Center) — Sponsor-investigator
First posted
Apr 8, 2011
Start date
Mar 2011
Primary completion
May 2011
Completion
May 2011
Last update
Jul 20, 2012

Study contacts

Tracie C Collins, MD, MPH
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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