STEPUP Clinical Trial

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445375
• Other study ID #: STU00215376
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: December 15, 2025

Study information

• Verified date: September 2023
• Source: Northwestern University
• Contact: Karen J Ho, MD
• Phone: 3126954952
• Email: kho1[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• PAD education video
20-min online multi-media video

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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