- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321086
Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD)
Promoting Walking in African Americans With Peripheral Arterial Disease
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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).
- 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).
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Fairway, Kansas, United States, 66205
- Clinical and Translational Science Unit
-
Wichita, Kansas, United States, 67214
- KU School of Medicine-Wichita
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- African American (determined by self-report)
- Lived most of their life in the United States
- Resting ABI <0.995
- 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); 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.
- 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; the rationale is that post intervention recovery and potential complications are likely to limit the patient's ability to adhere to the study protocol.
- 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.
- 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.
- 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.
- 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).
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
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.
|
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).
|
9 sessions of PACE delivered from baseline to six months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Minute Walk Test
Time Frame: 6 months
|
Distance walked in 6 minutes
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery (SPPB)
Time Frame: Baseline
|
Assessment of balance and basic physical mobility
|
Baseline
|
Blood work for glucose and lipid levels
Time Frame: Baseline
|
glycosylated hemoglobin (HbA1C) and a fasting lipid profile
|
Baseline
|
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.
|
Baseline
|
Ankle-Brachial Index (ABI)
Time Frame: Baseline
|
An assessment that is used to determine the severity of peripheral arterial disease.
|
Baseline
|
Quality of Life
Time Frame: Baseline
|
The SF-12 and VascQOL questionnaires will be used to assess QOL.
|
Baseline
|
6 minute walk test
Time Frame: 12 months
|
Distance walked in 6 minutes
|
12 months
|
6 minute walk test
Time Frame: Baseline
|
Distance walked in 6 minutes
|
Baseline
|
Short physical performance battery (SPPB)
Time Frame: 6 months
|
Assessment of balance and basic physical mobility
|
6 months
|
Short Physical Performance Battery (SPPB)
Time Frame: 12 months
|
Assessment of balance and basic physical mobility
|
12 months
|
Blood work for glucose and lipid levels
Time Frame: 6 months
|
HbA1C and a fasting lipid profile
|
6 months
|
Blood work for glucose and lipid levels
Time Frame: 12 months
|
HbA1C and a fasting lipid profile
|
12 months
|
Ankle-Brachial Index (ABI)
Time Frame: 12 months
|
An assessment that is used to determine the severity of peripheral arterial disease.
|
12 months
|
Quality of Life
Time Frame: 6 months
|
The SF-12 and VascQOL questionnaires will be used to assess QOL.
|
6 months
|
Quality of life
Time Frame: 12 months
|
The SF-12 and VascQOL questionnaires will be used to assess QOL.
|
12 months
|
Dietary habits for fats and fruits and vegetables
Time Frame: baseline
|
Assessment of fats and fruit and vegetable intake
|
baseline
|
Dietary habits for fats and fruits and vegetables
Time Frame: 6 months
|
Assessment of fats and fruit and vegetable intake
|
6 months
|
Dietary habits for fats and fruits and vegetables
Time Frame: 12 months
|
Assessment of fats and fruit and vegetable intake
|
12 months
|
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.
|
6 months
|
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.
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tracie C Collins, MD, MPH, KU School of Medicine-Wichita
Publications and helpful links
General Publications
- Collins TC, Lu L, Ahluwalia JS, Nollen NL, Sirard J, Marcotte R, Post S, Zackula R. Efficacy of Community-Based Exercise Therapy Among African American Patients With Peripheral Artery Disease: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e187959. doi: 10.1001/jamanetworkopen.2018.7959.
- Love B, Nwachokor D, Collins T. Recruiting African Americans with peripheral artery disease for a behavioral intervention trial. Vasc Med. 2016 Aug;21(4):345-51. doi: 10.1177/1358863X16628646. Epub 2016 Feb 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7R01HL098909-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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