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

NCT ID: NCT01332058

Last Updated: 2012-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-05-31

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.

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease; Walking; Motivational Interviewing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Motivational Interviewing (MI)

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

8 possible weeks of motivational interviewing sessions

Interventions

Motivational Interviewing

8 possible weeks of motivational interviewing sessions

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Tracie Collins, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Tracie Collins, MD, MPH

Preventive Medicine and Public Health Chair

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tracie C Collins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Wichita, Kansas, United States

Countries

United States

Other Identifiers

R01HL098909

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7R01HL098909-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL09890901 - Pilot

Identifier Type: -

Identifier Source: org_study_id