PAD Education Video for Peripheral Arterial Disease

Overseen By Karen J Ho, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Informed consent, Study protocol, Viewed video, Pilot study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new educational approach for patients with peripheral artery disease (PAD), which affects blood flow in the legs. It compares the current education method with an added online video (PAD education video) to determine if it enhances patient knowledge and self-care. Ideal candidates are those preparing for PAD surgery at Northwestern Memorial Hospital who have not previously viewed this video. Participants will be randomly assigned to one of two groups and will follow the study for six months. The study includes interviews to gather additional insights. As an unphased trial, it offers participants the chance to contribute to innovative educational methods that could improve patient care.

Do I have to stop taking my current medications for this trial?

The protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this education video is safe for patients with PAD?

This trial does not test any new drugs or medical procedures. Instead, it focuses on an educational video about peripheral artery disease (PAD). Research has shown that educational videos can be safe and effective for learning. The video aims to help patients better understand PAD and manage their care.

Since this trial involves no physical treatments or medications, there are no risks such as side effects. The video serves as an additional resource to enhance existing education, ensuring no safety concerns for participants. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the PAD education video trial because it seeks to enhance patient understanding and engagement through an innovative approach. Unlike the standard practice, which typically involves a pamphlet and verbal instructions, this video offers a more comprehensive, accessible, and engaging way to learn about Peripheral Arterial Disease. The video format can cater to various learning styles and ensure patients retain crucial information about their condition. This method has the potential to improve patient outcomes by empowering them with knowledge and encouraging proactive management of their health.

What evidence suggests that the PAD education video is effective for improving self-care engagement in PAD patients?

Research has shown that adding an online video to traditional teaching methods can help patients better understand and manage peripheral artery disease (PAD). In this trial, participants in the intervention arm will receive the current education regimen and watch a 20-minute online PAD education video. One study found that patients gave positive feedback on an online PAD education tool, noting it helped them understand their condition better. Another study demonstrated that videos can greatly enhance patients' understanding of PAD, simplifying complex information. These findings suggest that incorporating a video into PAD education could improve patients' knowledge and involvement in their own care. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

The STEPUP trial is for patients scheduled for surgery to treat Peripheral Arterial Disease (PAD) at Northwestern Memorial Hospital. It's not open to those who were in the pilot study, have already seen the PAD education video, or can't consent or follow the study rules.

Inclusion Criteria

I am having surgery for PAD at Northwestern Memorial Hospital.

Exclusion Criteria

You have participated in a preliminary study.

Previously viewed the PAD education video

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education Intervention

Participants receive either the current education regimen or the current regimen with an additional online multimedia patient education video

6 months

Baseline visit (in-person or virtual)

Follow-up

Participants are monitored for changes in self-care engagement, self-efficacy, PAD knowledge, and activation

6 months

Follow-up assessment (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PAD education video

Trial Overview This trial tests if adding an online patient education video about PAD to existing educational materials helps improve patients' understanding of their condition and self-care after surgery. Participants are split into two groups: one with standard education and one with additional video content.

How Is the Trial Designed?

Group I: Current education regimen Active Control 1 Intervention

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

Group II: Intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A 2-day PAD Public Education Strategy Meeting brought together representatives from 17 professional societies to create a national awareness campaign aimed at reducing the health impact of peripheral arterial disease (PAD) in the U.S.

The meeting resulted in a consensus to develop unified public education messages about PAD, with the goal of improving cardiovascular health outcomes and reaching all Americans at risk, supported by the Vascular Disease Foundation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mandate for creation of a national peripheral arterial disease public awareness program: an opportunity to improve cardiovascular health. Hirsch, AT., Gloviczki, P., Drooz, A., et al.[2015]

A study of 62 incoming internal medicine interns revealed that they had a low overall knowledge of peripheral arterial disease (PAD), answering only 41.7% of questions correctly across various categories.

The interns performed particularly poorly in the screening category, with only 33.8% correct answers, highlighting a need for improved education on PAD during medical training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal medicine interns have a poor knowledge of peripheral artery disease. Schwarcz, AI., Quijano, A., Olin, JW., et al.[2015]

Intermittent pneumatic compression (IPC) devices significantly improve blood flow and walking distance in patients with peripheral arterial disease (PAD), showing increases in popliteal artery velocity and flow, as well as improvements in quality of life over 4.5-6 months.

IPC has also demonstrated effectiveness in critical limb ischemia (CLI) by reducing rest pain and promoting ulcer healing, with limb salvage rates ranging from 58-94% over 1.5-3.5 years, indicating its potential as a valuable treatment option for severe cases of PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Management of Peripheral Arterial Disease. Williams, KJ., Babber, A., Ravikumar, R., et al.[2017]

In a study of 1263 patients with peripheral artery disease (PAD) who underwent endovascular revascularization, those with diabetes mellitus (DM) and who did not engage in regular exercise experienced a significantly shorter time without major adverse events.

Patients with critical limb ischemia or chronic kidney disease were found to have an increased risk of major adverse events, highlighting the importance of targeted management for these high-risk groups to improve outcomes after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major Adverse Events in Patients with Peripheral Artery Disease after Endovascular Revascularization: A Retrospective Study. Kim, M., Yang, YS., Ko, YG., et al.[2023]

The Peripheral Arterial Disease Knowledge Questionnaire (PADKQ) demonstrated good reliability and validity in assessing patients' knowledge about PAD, with a significant increase in knowledge observed after an educational intervention among 114 patients.

Higher levels of knowledge about PAD were associated with increased physical activity, indicating that educating patients can lead to better health behaviors and potentially improve outcomes in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Do Patients Know About Peripheral Arterial Disease? A Knowledge Questionnaire. Pedras, S., Oliveira, R., Veiga, C., et al.[2023]

Patients with peripheral artery disease reported positive experiences with the ankle-foot orthosis (AFO) in terms of usability and cost-effectiveness, indicating that the device was easy to use and had no out-of-pocket costs during the 3-month intervention.

Despite initial positive feedback, challenges related to motivation and the AFO's impact on daily activities led to lower compliance after the intervention, highlighting the need to address patients' perceptions to improve long-term use and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework. Bashir, AZ., Dinkel, DM., Pipinos, II., et al.[2023]

In a study of 13,885 patients with peripheral artery disease (PAD), women showed a significantly lower risk of major adverse cardiovascular events (MACE) and all-cause mortality compared to men, with adjusted hazard ratios of 0.77 and 0.61, respectively, over a mean follow-up of 30 months.

Despite the lower risk of MACE and mortality in women, the incidence of major adverse limb events and hospitalization for acute limb ischemia was similar between sexes, indicating that while cardiovascular risks differ, limb-related complications do not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease. Haine, A., Kavanagh, S., Berger, JS., et al.[2020]

A systematic review of six studies involving 1087 participants found that structured patient education interventions have the potential to improve physical activity in patients with peripheral arterial disease (PAD) and intermittent claudication (IC), but the evidence remains inconclusive.

Patients reported that these educational interventions were valuable and motivating, helping them to manage their condition better, highlighting the importance of considering patient experiences in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Structured Patient Education on Physical Activity in Patients with Peripheral Arterial Disease and Intermittent Claudication: A Systematic Review. Abaraogu, UO., Dall, PM., Seenan, CA.[2021]

A 2-day PAD Public Education Strategy Meeting brought together representatives from 17 professional societies to create a national awareness campaign aimed at reducing the health impact of peripheral arterial disease (PAD) in the U.S.

The meeting resulted in a consensus to develop unified public education messages about PAD, with the goal of improving cardiovascular health outcomes and reaching all Americans at risk, supported by the Vascular Disease Foundation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mandate for creation of a national peripheral arterial disease public awareness program: an opportunity to improve cardiovascular health. Hirsch, AT., Gloviczki, P., Drooz, A., et al.[2017]

Only 65.4% of patients with peripheral artery disease (PAD) were aware of their diagnosis, indicating a significant gap in disease awareness that could impact their treatment decisions and health outcomes.

Patients expressed a strong desire for more education on PAD, particularly regarding dietary recommendations, causes, and treatment options, highlighting the need for improved educational strategies to enhance patient knowledge and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying gaps in disease knowledge among patients with peripheral artery disease. Byskosh, N., Pamulapati, V., Xu, S., et al.[2023]

Men with peripheral artery disease (PAD) have a higher risk of all-cause mortality and major adverse cardiovascular events (MACE) compared to women, with hazard ratios indicating a 13% and 10% increased risk, respectively.

The increased mortality risk in men is particularly evident in patients with critical limb ischemia and mixed clinical presentations, as well as after procedures like revascularization and hospitalization, suggesting that gender differences significantly impact long-term outcomes in PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of gender differences in long-term mortality and cardiovascular events in peripheral artery disease. Parvar, SL., Thiyagarajah, A., Nerlekar, N., et al.[2022]

Participants with peripheral arterial disease (PAD) reported a significant lack of understanding about their condition, leading to confusion about self-management strategies, which highlights the need for better education and information access.

The study revealed that pain and mobility issues were particularly challenging for older individuals living alone, suggesting that integrated care involving multidisciplinary teams and case managers is essential to address their unique needs and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifaceted needs of individuals living with peripheral arterial disease: A qualitative study. DiGiacomo, M., Prichard, R., Allida, S., et al.[2022]

A 2-day PAD Public Education Strategy Meeting brought together representatives from 17 professional societies to create a national awareness campaign aimed at reducing the health impact of peripheral arterial disease (PAD) in the U.S.

The meeting resulted in a consensus to develop unified public education messages about PAD, with the goal of improving cardiovascular health outcomes for Americans at risk, supported by the Vascular Disease Foundation and a coalition of stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special communication: mandate for creation of a national peripheral arterial disease public awareness program: an opportunity to improve cardiovascular health. Hirsch, AT., Gloviczki, P., Drooz, A., et al.[2017]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2949912725000200

Patient perspectives on peripheral artery disease ... The objectives of this study were to understand patient perspectives on PAD education and obtain their feedback on an online PAD video education tool.

2. youtube.com youtube.com/watch?v=cFKTloHw8wg

Peripheral Artery Disease (PAD): Symptoms & Treatments ... The most common symptom is pain or cramping in the legs that occurs with walking or exercise and goes away after a few minutes of rest.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949912725000753

Multidisciplinary clinician perspectives on peripheral artery ... This study of clinicians who treat PAD generates important narrative insights into the challenges of clinician-led PAD education.

4. education.heart.org education.heart.org/productdetails/peripheral-artery-disease-pad-for-professionals-video-series-b?detailsBreadCrumbTitle=Premium%20Content

Peripheral Artery Disease (PAD) for Professionals video ... The activities included are: Diagnosing and Managing Patients with Peripheral Artery Disease (PAD); Health Equity and Peripheral Arterial Disease: How Do We ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215088/

Development of an Audiovisual Tool on Peripheral Arterial ... An audiovisual tool was developed to promote literacy about peripheral arterial disease (PAD) in a hospital setting, and a preliminary evaluation of the tool's ...

6. mayoclinic.org mayoclinic.org/vid-20571248

What is peripheral artery disease? It's often treated with medicines and a walking program. But severe PAD can lead to complications, including gangrene. In this video, Mayo Clinic vascular ...

7. medtronic.com medtronic.com/en-us/l/patients/conditions/peripheral-arterial-disease.html

Peripheral Arterial Disease (PAD) - Patient Information PAD describes blocked arteries outside of the heart. It is a buildup of plaque in the walls of arteries, which limits or stops the flow of blood to your limbs.

8. youtube.com youtube.com/watch?v=XTSgpiPqIbk

PAD: What is it? Learn more about Peripheral Artery Disease (PAD) and how this condition increases your risk for heart attack or stroke.