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

NCT01332058 | Completed

• 3 other identifiers: R01HL09890901 - PilotR01HL0989097R01HL098909-03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease; Walking; Motivational Interviewing

Outcome Measures

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.

  8 weeks

Secondary Outcomes (3)

• Baseline six minute walk test

  baseline

• Baseline 7 day physical activity

  baseline

• Change from baseline to eight weeks 7 day physical activity

  8 weeks

Study Arms (1)

Motivational Interviewing (MI)

EXPERIMENTAL

Behavioral: Motivational Interviewing

Interventions

Motivational Interviewing BEHAVIORAL

8 possible weeks of motivational interviewing sessions

Motivational Interviewing (MI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tracie Collins, MD, MPH: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Kansas Medical Center

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tracie C Collins, MD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Preventive Medicine and Public Health Chair

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: April 8, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

US (1)