STEPUP Clinical Trial

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Other: PAD education video

• Registration Number: NCT05445375
• Lead Sponsor: Northwestern University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-06
• Primary Completion: 2024-03-07
• Study Completion: 2024-03-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	PAD education video	Participants will be given the current education regimen and watch a 20 minute online PAD education video.

Primary Outcome Measures

Name	Time	Method
Readiness to change self-care engagement	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.

Secondary Outcome Measures

Name	Time	Method
Activation level	Baseline to six-month follow-up	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.
PAD knowledge and beliefs	Baseline to six-month follow-up	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.
Self-efficacy	Baseline to six-month follow-up	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States