STEPUP Clinical Trial

NCT ID: NCT05445375

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2024-03-07

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Current education regimen

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type ACTIVE_COMPARATOR

PAD education video

Intervention Type OTHER

20-min online multi-media video

Interventions

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PAD education video

20-min online multi-media video

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00215376

Identifier Type: -

Identifier Source: org_study_id

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