Peripheral Arterial DiseaseNCT01332058
Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD) Pilot
A study testing Motivational Interviewing in people with Peripheral Arterial Disease, run by Tracie Collins, MD, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- 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 <0.95
- 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)
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Wichita, Kansas, 67214
About this study
Official title: Promoting Walking in African Americans With Peripheral Arterial Disease
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.
Read the 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
- Being tested
- Motivational Interviewing
- Keywords
- Peripheral arterial disease, Walking, Motivational Interviewing
- 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
8 possible weeks of motivational interviewing sessions
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Baseline six 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.
Measured: baseline
Baseline 7 day physical activity
Each participant will wear an accelerometer for one week at baseline to collect their current level physical activity. The accelerometers will collect movement in x, y, and z axis as well as total steps. They will be asked to put the accelerometer on first thing in the morning and take it right before bed.
Measured: baseline
Change from baseline to eight weeks 7 day physical activity
Each participant will wear an accelerometer for one week at baseline to collect their current level physical activity. The accelerometers will collect movement in x, y, and z axis as well as total steps. They will be asked to put the accelerometer on first thing in the morning and take it right before bed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracie Collins, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Tracie Collins, MD, MPH, University of Kansas Medical Center
- Investigators
- Tracie C Collins, MD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332058
- Sponsor's protocol ID
- R01HL09890901 - Pilot
- Other IDs
- R01HL098909, 7R01HL098909-03
- Status last verified
- Jul 2012
- First submitted
- 16 Feb 2011
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. 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
- NCT01332058
- Acronym / sponsor ID
- R01HL09890901 - Pilot
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease, Walking, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tracie Collins, MD, MPHUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Apr 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 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Behavioral: Motivational Interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 <0.95
- English Speaking
- Has a telephone
Key exclusion criteria (10 listed)
- 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
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 Interviewing8 possible weeks of motivational interviewing sessions | Behavioural | Motivational Interviewing (MI) |
Primary outcome
Change from baseline to eight weeks in 6 minute walk test
Time frame: 8 weeks
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.
3 secondary outcomes
Baseline six minute walk test
Time frame: baseline
Baseline 7 day physical activity
Time frame: baseline
Change from baseline to eight weeks 7 day physical activity
Time frame: 8 weeks
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 20 Jul 2012.
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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
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Peripheral Arterial Disease, run by Tracie Collins, MD, MPH at 1 site 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 10 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 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline to eight weeks in 6 minute walk test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2012.