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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tracie Collins, MD, MPH, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01332058
First received: February 16, 2011
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Behavioral: Motivational Interviewing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Promoting Walking in African Americans With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change from baseline to eight weeks in 6 minute walk test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Baseline six minute walk test [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 7 day physical activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Change from baseline to eight weeks 7 day physical activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interviewing (MI) Behavioral: Motivational Interviewing
8 possible weeks of motivational interviewing sessions

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332058

Locations
United States, Kansas
University of Kansas Medical Center
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Tracie Collins, MD, MPH
Investigators
Principal Investigator: Tracie C Collins, MD, MPH University of Kansas
  More Information

No publications provided

Responsible Party: Tracie Collins, MD, MPH, Preventive Medicine and Public Health Chair, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01332058     History of Changes
Other Study ID Numbers: R01HL09890901 - Pilot, R01HL098909, 7R01HL098909-03
Study First Received: February 16, 2011
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Peripheral arterial disease
Walking
Motivational Interviewing

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014