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NCT Number: NCT05445375

STEPUP Clinical Trial

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAD education video

Other

20-min online multi-media video

Primary outcomes

  1. 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

  1. PAD knowledge and beliefs

    Time frame: 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.

  2. Self-efficacy

    Time frame: 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.

  3. Activation level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2022
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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