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Clinical Trials/NCT05445375
NCT05445375
Completed
Not Applicable

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

Northwestern University1 site in 1 country125 target enrollmentJune 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Artery Disease
Sponsor
Northwestern University
Enrollment
125
Locations
1
Primary Endpoint
Readiness to change self-care engagement
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2022
End Date
March 7, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Activation level(Baseline to six-month follow-up)
  • PAD knowledge and beliefs(Baseline to six-month follow-up)
  • Self-efficacy(Baseline to six-month follow-up)

Study Sites (1)

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