STEPUP Clinical Trial
STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2022
CompletedFirst Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2024
CompletedFebruary 21, 2025
February 1, 2025
1.8 years
June 28, 2022
February 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
PAD knowledge and beliefs
Baseline to six-month follow-up
Self-efficacy
Baseline to six-month follow-up
Activation level
Baseline to six-month follow-up
Study Arms (2)
Current education regimen
NO INTERVENTIONParticipants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers.
Intervention
ACTIVE COMPARATORParticipants will be given the current education regimen and watch a 20 minute online PAD education video.
Interventions
Eligibility Criteria
You may qualify if:
- Patient undergoing surgery for PAD in Division of Vascular Surgery at Northwestern Memorial Hospital
You may not qualify if:
- Inability to provide informed consent
- Inability to complete study protocol
- Previously viewed the PAD education video
- Participation in pilot study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 6, 2022
Study Start
June 7, 2022
Primary Completion
March 7, 2024
Study Completion
March 7, 2024
Last Updated
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share