STEPUP Clinical Trial

Northwestern University

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Other: PAD education video

Study type: Interventional

Funder types: Other

Identifiers

NCT05445375

STU00215376

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

Current education regimen

No Intervention group

Description:

Participants will be given a PAD pamphlet and ad hoc verbal teaching by vascular providers.

Intervention

Active Comparator group

Description:

Participants will be given the current education regimen and watch a 20 minute online PAD education video.

Treatment:

Other: PAD education video