Peripheral Arterial DiseaseNCT01321086
Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD)
A study testing Motivational Interviewing and PACE in people with Peripheral Arterial Disease, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Motivational Interviewing and PACE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- African American (determined by self-report)
- Lived most of their life in the United States
- Resting ABI <0.995
- English Speaking
- Has a telephone
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical and Translational Science Unit
Fairway, Kansas, 66205
KU School of Medicine-Wichita
Wichita, Kansas, 67214
About this study
Official title: Promoting Walking in African Americans With Peripheral Arterial Disease
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.
Read the 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:
- 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Motivational Interviewing, PACE
- Keywords
- PAD
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
9 sessions of MI from baseline to six months
PACEBehavioural
9 sessions of PACE delivered from baseline to six months
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Active comparator | 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. Receives: Behavioral: Motivational Interviewing |
| PACE | Active comparator | 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). Receives: Behavioral: PACE |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
Distance walked in 6 minutes
Measured: 6 months
Secondary outcomes (19)
Short Physical Performance Battery (SPPB)
Assessment of balance and basic physical mobility
Measured: Baseline
Blood work for glucose and lipid levels
glycosylated hemoglobin (HbA1C) and a fasting lipid profile
Measured: Baseline
Adherence to Physical Activity
The participants will be asked to wear accelerometers for seven days at each of the three time points.
Measured: Baseline
Ankle-Brachial Index (ABI)
An assessment that is used to determine the severity of peripheral arterial disease.
Measured: Baseline
Quality of Life
The SF-12 and VascQOL questionnaires will be used to assess QOL.
Measured: Baseline
6 minute walk test
Distance walked in 6 minutes
Measured: 12 months
6 minute walk test
Distance walked in 6 minutes
Measured: Baseline
Short physical performance battery (SPPB)
Assessment of balance and basic physical mobility
Measured: 6 months
Short Physical Performance Battery (SPPB)
Assessment of balance and basic physical mobility
Measured: 12 months
Blood work for glucose and lipid levels
HbA1C and a fasting lipid profile
Measured: 6 months
Blood work for glucose and lipid levels
HbA1C and a fasting lipid profile
Measured: 12 months
Ankle-Brachial Index (ABI)
An assessment that is used to determine the severity of peripheral arterial disease.
Measured: 12 months
Quality of Life
The SF-12 and VascQOL questionnaires will be used to assess QOL.
Measured: 6 months
Quality of life
The SF-12 and VascQOL questionnaires will be used to assess QOL.
Measured: 12 months
Dietary habits for fats and fruits and vegetables
Assessment of fats and fruit and vegetable intake
Measured: baseline
Dietary habits for fats and fruits and vegetables
Assessment of fats and fruit and vegetable intake
Measured: 6 months
Dietary habits for fats and fruits and vegetables
Assessment of fats and fruit and vegetable intake
Measured: 12 months
Adherence to Physical Activity
The participants will be asked to wear accelerometers for seven days at each of the three time points.
Measured: 6 months
Adherence to Physical Activity
The participants will be asked to wear accelerometers for seven days at each of the three time points.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Tracie Collins, MD, MPH, University of Kansas Medical Center
- Investigators
- Tracie C Collins, MD, MPH, Principal investigator, KU School of Medicine-Wichita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321086
- Sponsor's protocol ID
- 7R01HL098909-03
- Other IDs
- 7R01HL098909-03
- Status last verified
- Jan 2017
- First submitted
- 16 Feb 2011
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30768192Love 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.
PubMed 26893320
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Walking in African Americans With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01321086
- Acronym / sponsor ID
- 7R01HL098909-03
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Active comparator | Behavioral: Motivational InterviewingMotivational 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. |
| PACE | Active comparator | Behavioral: PACEPatient-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). |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- African American (determined by self-report)
- Lived most of their life in the United States
- Resting ABI <0.995
- English Speaking
- Has a telephone
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing9 sessions of MI from baseline to six months | Behavioural | Motivational Interviewing |
| PACE9 sessions of PACE delivered from baseline to six months | Behavioural | PACE |
Primary outcome
6 Minute Walk Test
Time frame: 6 months
Distance walked in 6 minutes
19 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline
Blood work for glucose and lipid levels
Time frame: Baseline
Adherence to Physical Activity
Time frame: Baseline
Ankle-Brachial Index (ABI)
Time frame: Baseline
Quality of Life
Time frame: Baseline
6 minute walk test
Time frame: 12 months
6 minute walk test
Time frame: Baseline
Short physical performance battery (SPPB)
Time frame: 6 months
Short Physical Performance Battery (SPPB)
Time frame: 12 months
Blood work for glucose and lipid levels
Time frame: 6 months
Blood work for glucose and lipid levels
Time frame: 12 months
Ankle-Brachial Index (ABI)
Time frame: 12 months
Quality of Life
Time frame: 6 months
Quality of life
Time frame: 12 months
Dietary habits for fats and fruits and vegetables
Time frame: baseline
Dietary habits for fats and fruits and vegetables
Time frame: 6 months
Dietary habits for fats and fruits and vegetables
Time frame: 12 months
Adherence to Physical Activity
Time frame: 6 months
Adherence to Physical Activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Derived from this study: PubMed 30768192Collins 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.
- Derived from this study: PubMed 26893320Love 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracie C Collins, MD, MPH principal investigator
KU School of Medicine-Wichita
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and PACE in people with Peripheral Arterial Disease, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321086, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.