Peripheral Artery Disease
Conditions
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.
Interventions
OTHERPAD education video
20-min online multi-media video
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readiness to change self-care engagement | 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
| Measure | Time frame | Description |
|---|---|---|
| PAD knowledge and beliefs | 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. |
| Self-efficacy | 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. |
| Activation level | 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. |
Countries
United States
Outcome results
None listed