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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that PAD Education Video for Peripheral Arterial Disease is an effective treatment?

The available research does not provide specific data on the effectiveness of the PAD Education Video for treating Peripheral Arterial Disease. Instead, it highlights the importance of patient education in general for improving physical activity and understanding of the disease. There is a call for a national PAD public awareness program, suggesting that education can play a role in improving health outcomes, but no direct evidence from the research provided supports the effectiveness of the PAD Education Video specifically. ^{1 2 3 4 5}

What safety data exists for the PAD education video treatment?

The provided research does not contain specific safety data for the PAD education video treatment. The studies focus on various aspects of peripheral arterial disease, such as management, gender differences, major adverse events, and knowledge among medical interns, but do not address the safety of the PAD education video. ^{6 7 8 9 10}

Is the PAD Education Video a promising treatment for Peripheral Arterial Disease?

Yes, the PAD Education Video is a promising treatment because it helps patients understand their disease better. This understanding can lead to healthier lifestyle choices and better adherence to treatments, which can improve their overall health and outcomes. ^{1 9 11 12 13}

Eligibility Criteria

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

I cannot follow the study's required steps.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Identifying gaps in disease knowledge among patients with peripheral artery disease. [2023]

2. England 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. [2021]

3. United States 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. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Mandate for creation of a national peripheral arterial disease public awareness program: an opportunity to improve cardiovascular health. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Mandate for creation of a national peripheral arterial disease public awareness program: an opportunity to improve cardiovascular health. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Non-Invasive Management of Peripheral Arterial Disease. [2017]

7. United States 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Major Adverse Events in Patients with Peripheral Artery Disease after Endovascular Revascularization: A Retrospective Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Internal medicine interns have a poor knowledge of peripheral artery disease. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Sex-Specific Risks of Major Cardiovascular and Limb Events in Patients With Symptomatic Peripheral Artery Disease. [2020]

11. Portugal pubmed.ncbi.nlm.nih.gov

What Do Patients Know About Peripheral Arterial Disease? A Knowledge Questionnaire. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Multifaceted needs of individuals living with peripheral arterial disease: A qualitative study. [2022]

13. Netherlands 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. [2023]