STEPUP Clinical Trial
Primary Purpose
Peripheral Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAD education video
Sponsored by
About this trial
This is an interventional health services research trial for Peripheral Artery Disease
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
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Current education regimen
Intervention
Arm Description
Participants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers.
Participants will be given the current education regimen and watch a 20 minute online PAD education video.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05445375
First Posted
June 28, 2022
Last Updated
September 28, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05445375
Brief Title
STEPUP Clinical Trial
Official Title
STrategic Education for Patients Undergoing PAD Surgery (STEPUP Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Current education regimen
Arm Type
No Intervention
Arm Description
Participants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Participants will be given the current education regimen and watch a 20 minute online PAD education video.
Intervention Type
Other
Intervention Name(s)
PAD education video
Intervention Description
20-min online multi-media video
Primary Outcome Measure Information:
Title
Readiness to change self-care engagement
Description
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.
Time Frame
Baseline to six-month follow-up
Secondary Outcome Measure Information:
Title
PAD knowledge and beliefs
Description
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.
Time Frame
Baseline to six-month follow-up
Title
Self-efficacy
Description
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.
Time Frame
Baseline to six-month follow-up
Title
Activation level
Description
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.
Time Frame
Baseline to six-month follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen J Ho, MD
Phone
3126954952
Email
kho1@nm.org
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen J Ho, MD
Phone
312-695-4952
Email
kho1@nm.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
STEPUP Clinical Trial
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