Peripheral Artery DiseaseNCT05445375
STEPUP Clinical Trial
A study testing PAD education video in people with Peripheral Artery Disease, run by Northwestern University at 1 site in United States.
Trial summary
This study will test whether, among patients undergoing surgery for peripheral artery disease (PAD), the addition of an online multimedia patient education video to the current education regimen will improve PAD knowledge, activation, and self-care engagement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- PAD education video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 7 Mar 2024
- 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
- Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital
Who cannot join
- Inability to provide informed consent
- Inability to complete study protocol
- Previously viewed the PAD education video
- Participation in pilot study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)
This study will test whether, among patients undergoing surgery for peripheral artery disease (PAD), the addition of an online multimedia patient education video to the current education regimen will improve PAD knowledge, activation, and self-care engagement. The study will randomize 150 participants to one of 2 groups: current education regimen vs. current education regiment with video. The primary outcome is stage of self-care engagement. Secondary outcomes are PAD knowledge, self-efficacy, and activation. A subset of participants will also be randomly selected to participate in semi-structured interviews. Study duration for participants is 6 months.
- Conditions
- Peripheral Artery Disease
- Being tested
- PAD education video
- 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.
PAD education videoOther
20-min online multi-media video
| Study group | Role | What they receive |
|---|---|---|
| Current education regimen | No intervention | Participants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers. |
| Intervention | Active comparator | Participants will be given the current education regimen and watch a 20 minute online PAD education video. Receives: Other: PAD education video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness to change self-care engagement
Change in readiness to change self-care behaviors will be compared between the 2 groups. Readiness to change self-care behavior will be assessed as 1 of 5 stages in the Transtheoretical Model. Change in readiness to change behavior will be calculated as the difference between stages at baseline and six month follow-up (direction and magnitude). Assessment will occur in paper survey.
Measured: Baseline to six-month follow-up
Secondary outcomes (3)
PAD knowledge and beliefs
Change in PAD knowledge and beliefs will be compared between the 2 groups. Knowledge and beliefs will be assessed using multiple-choice questions in a paper survey.
Measured: Baseline to six-month follow-up
Self-efficacy
Change in self-efficacy will be compared between the 2 groups. Self-efficacy will be assessed using 5 questions adapted from the General Self-Efficacy Scale in a paper survey. Responses are recorded on a 5-point Likert scale. Summed scores will range from 5 (minimum, lowest level of self-efficacy) to 25 (maximum, highest level of self-efficacy). Change in self-efficacy will be calculated as the difference in sum scores.
Measured: Baseline to six-month follow-up
Activation level
Change in activation level will be compared between the 2 groups. Activation level will be assessed using the 13-item Patient Activation Measure (PAM-13), a validated instrument, which will be administered in a paper survey. The activation score is based on a 0-100-point scale (0=minimum, 100=maximum).The activation score is can be used to segment individuals into one of 4 progressively higher levels of activation. Change in activation score and level will be calculated as a difference in PAM-13 scores and levels.
Measured: Baseline to six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start7 Jun 2022
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445375
- Sponsor's protocol ID
- STU00215376
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)
- ClinicalTrials.gov ID
- NCT05445375
- Acronym / sponsor ID
- STU00215376
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 6 Jul 2022 (actual)
- 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.
This study will test whether, among patients undergoing surgery for peripheral artery disease (PAD), the addition of an online multimedia patient education video to the current education regimen will improve PAD knowledge, activation, and self-care engagement. The study will randomize 150 participants to one of 2 groups: current education regimen vs. current education regiment with video. The primary outcome is stage of self-care engagement. Secondary outcomes are PAD knowledge, self-efficacy, and activation. A subset of participants will also be randomly selected to participate in semi-structured interviews. Study duration for participants is 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current education regimen | No intervention | –Participants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers. |
| Intervention | Active comparator | Other: PAD education videoParticipants will be given the current education regimen and watch a 20 minute online PAD education video. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Inability to complete study protocol
- Previously viewed the PAD education video
- Participation in pilot study
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 |
|---|---|---|
| PAD education video20-min online multi-media video | Other | Intervention |
Primary outcome
Readiness to change self-care engagement
Time frame: Baseline to six-month follow-up
Change in readiness to change self-care behaviors will be compared between the 2 groups. Readiness to change self-care behavior will be assessed as 1 of 5 stages in the Transtheoretical Model. Change in readiness to change behavior will be calculated as the difference between stages at baseline and six month follow-up (direction and magnitude). Assessment will occur in paper survey.
3 secondary outcomes
PAD knowledge and beliefs
Time frame: Baseline to six-month follow-up
Self-efficacy
Time frame: Baseline to six-month follow-up
Activation level
Time frame: Baseline to six-month follow-up
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAD education video in people with Peripheral Artery Disease, run by Northwestern University 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 1 inclusion and 4 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 21 Feb 2025. 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?
Readiness to change self-care engagement (time frame: Baseline to six-month follow-up). 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 21 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.