We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01321086
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The investigators are conducting a clinical research trial to determine the role of motivational interviewing (MI) on promoting home-based walking therapy to improve walking ability in African Americans with peripheral arterial disease (PAD). African Americans are more than two times as likely as non-Hispanic whites to suffer from PAD. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. The investigators will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function. In order to motivate the participants to walk, the investigators included two different intervention strategies: MI and patient-centered counseling for exercise (PACE). The investigators hypothesize that participants randomized to the MI arm will have a greater increase in their walking distance, compared to those receiving Patient-Centered Assessment and Counseling for Exercise (PACE) and the control group.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Behavioral: Motivational Interviewing Behavioral: PACE

Detailed Description:

MI is an effective counseling method in individuals who are less ready to change their behavior (i.e., low motivation). Thus, MI is an ideal counseling method to promote home-based walking among AAs with PAD. In our pilot study to promote home-based walking, we used a counseling protocol, Patient-centered Assessment and Counseling for Exercise (PACE)(Sallis et al), which targets known modifiable determinants of behavior change (e.g., social support). Using PACE, we demonstrated an improvement in stair climbing ability and lower limb blood flow (as measured by the ankle-brachial index). Improvements in these lower limb outcomes offer support for the use of PACE counseling in PAD, but PACE does not specifically address low motivation - a critical target for AAs with PAD. In addition, PACE is not culturally sensitive. In our proposed trial, we hypothesize that MI will improve walking distance and reduce walking impairment more than PACE in AAs with PAD.

There is a critical need to improve lower limb outcomes in AAs with PAD. Our long-term goal is to reduce debilitating functional limitations and amputations in AAs with PAD. The overall objective of this application is to determine the most effective counseling strategy to improve home-based walking in AAs with PAD. We have assembled an excellent and diverse research team with the requisite skills and experience needed for this study. Moreover, we have robust pilot data to support the study hypotheses and ensure successful completion of the study.

We will deliver the PACE protocol or MI for 6 months, using both face-to-face visits and telephone contact. Our primary outcome is walking distance (as measured by the widely used and well-validated 6-minute walk test) at the end of active intervention (6 months). Secondary outcomes are walking distance as measured beyond the active phase of intervention (12 months), use of home-based walking (as measured by accelerometry), and lower limb blood flow (as measured by the ankle brachial index - ABI). Our comparison group will receive the same print material as the two interventions as well as contact every three months to update any changes in contact information and to assess their health status. We will randomize 204 participants to one of three arms: Control or Treatment One (Tx1); PACE or Treatment Two (Tx2); or MI, also referred to as Treatment Three (Tx3). In addition, we will determine the efficacy of PACE (Tx2) to increase walking distance in AAs with PAD, compared to Control (Tx1).

Primary Hypothesis:

1. At 6 months, AAs with PAD randomized to MI (Tx3) will have a greater increase in their walking distance, compared to those receiving PACE (Tx2) and the control group (Tx1).

Secondary Hypotheses:

  1. AAs with PAD randomized to MI (Tx3) will have a greater increase in their walking distance at 12 months - a follow-up period beyond the six months of active intervention - compared to those receiving PACE (Tx2) and compared to the control group (Tx1).
  2. At 6 and 12 months, AAs with PAD randomized to MI (Tx3) will have a greater increase in their home-based walking and their lower limb blood flow, compared to those receiving PACE (Tx2) and to the control group (Tx1).
  3. At 6 and 12 months, AAs with PAD randomized to PACE (Tx2) will have a greater increase in their walking distance compared to those randomized to control (Tx1).

Exploratory Aim:

We will explore potential mediators (self-efficacy, social support, intrinsic/extrinsic motivation) and moderators (co-morbidities, leg symptom type, stage of change) of intervention effects on walking distance, home-based walking, and lower limb blood flow among AAs with PAD.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Walking in African Americans With Peripheral Arterial Disease
Study Start Date : June 2011
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Motivational Interviewing
Motivational Interviewing (MI) is an effective counseling method in individuals who are less ready to change their behavior. 9 MI sessions will be conducted over the course of the six month intervention.
Behavioral: Motivational Interviewing
9 sessions of MI from baseline to six months
Active Comparator: PACE
Patient-centered Assessment and Counseling for Exercise (PACE) is a protocol that targets known modifiable determinants of behavior change to motivate participants to increase their physical activity (walking).
Behavioral: PACE
9 sessions of PACE delivered from baseline to six months
No Intervention: Control


Outcome Measures

Primary Outcome Measures :
  1. 6 Minute Walk Test [ Time Frame: 6 months ]
    Distance walked in 6 minutes


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: Baseline ]
    Assessment of balance and basic physical mobility

  2. Blood work for glucose and lipid levels [ Time Frame: Baseline ]
    glycosylated hemoglobin (HbA1C) and a fasting lipid profile

  3. Adherence to Physical Activity [ Time Frame: Baseline ]
    The participants will be asked to wear accelerometers for seven days at each of the three time points.

  4. Ankle-Brachial Index (ABI) [ Time Frame: Baseline ]
    An assessment that is used to determine the severity of peripheral arterial disease.

  5. Quality of Life [ Time Frame: Baseline ]
    The SF-12 and VascQOL questionnaires will be used to assess QOL.

  6. 6 minute walk test [ Time Frame: 12 months ]
    Distance walked in 6 minutes

  7. 6 minute walk test [ Time Frame: Baseline ]
    Distance walked in 6 minutes

  8. Short physical performance battery (SPPB) [ Time Frame: 6 months ]
    Assessment of balance and basic physical mobility

  9. Short Physical Performance Battery (SPPB) [ Time Frame: 12 months ]
    Assessment of balance and basic physical mobility

  10. Blood work for glucose and lipid levels [ Time Frame: 6 months ]
    HbA1C and a fasting lipid profile

  11. Blood work for glucose and lipid levels [ Time Frame: 12 months ]
    HbA1C and a fasting lipid profile

  12. Ankle-Brachial Index (ABI) [ Time Frame: 12 months ]
    An assessment that is used to determine the severity of peripheral arterial disease.

  13. Quality of Life [ Time Frame: 6 months ]
    The SF-12 and VascQOL questionnaires will be used to assess QOL.

  14. Quality of life [ Time Frame: 12 months ]
    The SF-12 and VascQOL questionnaires will be used to assess QOL.

  15. Dietary habits for fats and fruits and vegetables [ Time Frame: baseline ]
    Assessment of fats and fruit and vegetable intake

  16. Dietary habits for fats and fruits and vegetables [ Time Frame: 6 months ]
    Assessment of fats and fruit and vegetable intake

  17. Dietary habits for fats and fruits and vegetables [ Time Frame: 12 months ]
    Assessment of fats and fruit and vegetable intake

  18. Adherence to Physical Activity [ Time Frame: 6 months ]
    The participants will be asked to wear accelerometers for seven days at each of the three time points.

  19. Adherence to Physical Activity [ Time Frame: 12 months ]
    The participants will be asked to wear accelerometers for seven days at each of the three time points.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. African American (determined by self-report)
  2. Lived most of their life in the United States
  3. Resting ABI <0.995
  4. English Speaking
  5. Has a telephone

Exclusion Criteria:

  1. Currently walking for exercise at least 5 days per week (i.e., a PACE score ranging from 5-8); the rationale is that a person who is currently walking for at least 5 days per week is already sufficiently active and therefore not a member of the target population for our motivational home-based walking intervention.
  2. Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
  3. 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
  4. Leg revascularization within 3 months of enrollment or plans for revascularization during the study period; the rationale is that post intervention recovery and potential complications are likely to limit the patient's ability to adhere to the study protocol.
  5. Use of supplemental oxygen; the rationale for this is concern for participant safety and potential limited ability to participate in the study secondary to breathing difficulty.
  6. Myocardial infarction within the preceding 3 months; the rationale for this is participant safety and the potential risk for complications and/or the need for supervised cardiac rehabilitation following the event.
  7. Resting blood pressure > 200/110 mmHg; the rationale for this is participant safety, as blood pressure may further increase during exercise and increase risk for a cerebrovascular event or myocardial infarction.
  8. Exercise-induced coronary ischemic symptoms, or exercise-induced ST depression > 2.0 mm; the rationale for this is participant safety and the need for further cardiac evaluation prior to involvement in walking therapy (American College of Cardiology/American Heart Association, 2006).
  9. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321086


Locations
United States, Kansas
Clinical and Translational Science Unit
Fairway, Kansas, United States, 66205
KU School of Medicine-Wichita
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
University of Kansas Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Tracie C Collins, MD, MPH KU School of Medicine-Wichita
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tracie Collins, MD, MPH, Preventive Medicine and Public Health Chair, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01321086     History of Changes
Other Study ID Numbers: 7R01HL098909-03 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Tracie Collins, MD, MPH, University of Kansas Medical Center:
PAD

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