STEPUP Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Other: PAD education video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital Exclusion Criteria: Inability to provide informed consent Inability to complete study protocol Previously viewed the PAD education video Participation in pilot study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Current education regimen<br>Participants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers. | |
| Active Comparator: Intervention<br>Participants will be given the current education regimen and watch a 20 minute online PAD education video. | Other: PAD education video<br>* 20-min online multi-media video<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to six-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline to six-month follow-up |