Enrollment Strategy for Peripheral Arterial Disease

Overseen By Samantha Coratti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Unwillingness to be contacted

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 aims to determine if the method of invitation affects participation in a study on increasing physical activity for individuals with peripheral artery disease (PAD). It will compare two approaches: one requiring patients to actively choose to join (opt-in) and another automatically including them unless they decline (opt-out). The trial seeks participants with PAD who have received treatment at the University of Pennsylvania Health System and have an email address on file. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance patient engagement strategies.

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

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

What prior data suggests that this enrollment strategy is safe for patients with peripheral artery disease?

Research has shown that the opt-out strategy in clinical trials is a new method that does not involve physical treatment or medication. Instead, it alters how individuals are invited to join a study. Since this pertains to communication, it lacks the safety concerns associated with drugs or medical devices.

For those considering joining a trial using an opt-out strategy, there is no physical risk involved. The "treatment" is merely the method of invitation. It aims to simplify and streamline the process of joining. Overall, the opt-out approach is safe because it does not involve any physical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new strategies for enrolling patients with Peripheral Arterial Disease (PAD) into studies, which could improve participation rates. Traditional treatments for PAD include medications like statins and antiplatelets, as well as surgical interventions. However, this trial tests an "opt-out" enrollment strategy, which frames study participation as part of standard care, potentially increasing patient involvement without them having to take the first step. This approach could lead to more robust data collection and a better understanding of PAD treatments by seamlessly integrating research into regular patient care.

What evidence suggests that this trial's treatments could be effective for increasing participation in a study for peripheral artery disease?

Studies have shown that walking can benefit people with peripheral arterial disease (PAD). Walking increases both the distance and duration that individuals can walk and enhances overall well-being. Research suggests that home-based walking programs, which are more accessible for PAD patients, show promise, though their full effectiveness remains unproven. This trial will compare two enrollment strategies: an opt-in method, where participants actively choose to join, and an opt-out method, where participation is part of standard care unless declined. Although the direct impact of the opt-out method on results is unclear, emphasizing walking and increasing participation could benefit those with PAD. ^{1 5 6 7 8}

Who Is on the Research Team?

Alexander Fanaroff, MD, MHS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with peripheral artery disease (PAD) who have been treated within the University of Pennsylvania Health System and have an email on file there. It's not open to those who've opted out of research contact via email.

Inclusion Criteria

Have been seen in the University of Pennsylvania Health System

Have an email address on file with the University of Pennsylvania Health System

You have a medical diagnosis of peripheral artery disease listed in your medical records.

Exclusion Criteria

Previously indicated unwillingness to be contacted by email for participation in research studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are contacted via email to determine their interest in participation and are randomized to opt-in or opt-out framing for enrollment

4 weeks

Online enrollment with optional phone assistance

Intervention

Participants engage in a home-based walking program with automated coaching, augmented with gamification and behavioral economic principles

16 weeks

Follow-up

Participants are monitored for changes in step count and patient-reported symptom scores

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Opt-out

Trial Overview The study is examining if changing the way patients are invited to join a clinical trial—either by opting in or being automatically included unless they opt out—affects enrollment numbers and participant diversity.

How Is the Trial Designed?

Group I: Opt-out Experimental Treatment 1 Intervention

Patients randomized to opt-out framing will receive an email that frames participation in the study as part of the standard of care, and will be informed that a study coordinator will be calling them in the coming days to start enrollment in the study unless they opt out of participation.

Group II: Opt-in Active Control 1 Intervention

Patients randomized to opt-in framing will be instructed to visit the Way to Health website to enroll in the study, or to call or email the study coordinator with questions or for assistance in enrolling.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38354997/

Rationale and design of the GAMEPAD Study GAMEPAD is a virtual, pragmatic randomized clinical trial of a novel, fully home-based walking intervention informed by concepts from behavioral economics.

2. sciencedirect.com sciencedirect.com/science/article/am/pii/S0002870324000309

Rationale and design of the GAMEPAD Study A home-based walking intervention is likely to be more accessible to patients with PAD, but no fully home-based walking program has demonstrated efficacy.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.011506

One-Year Health Status Outcomes Following Early ... The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7 ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/1358863X231215246

Uptake and outcomes of supervised exercise therapy for ... Results: Of 5320 patients with PAD, N = 773 were referred to SET; N = 415 enrolled and were included in the present study. Vascular medicine ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06033924

Telehealth Delivered Home-based Walking for Vets With ... Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10734315/

Diversity in clinical trial inclusion for peripheral artery disease ... This study aims to review clinical trials focused on peripheral artery disease (PAD) patients who have received below-the-knee catheter-based interventions.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0741521421008971

Patient-reported outcomes for peripheral vascular ... The data on PAD PROs will be included in VQI reports to centers. We envision a time when clinicians will have access to longitudinal PROs for their patients.

8. evtoday.com evtoday.com/news/bd-begins-postmarket-xtract-registry-of-rotarex-catheter-to-treat-pad

BD Begins Postmarket XTRACT Registry of Rotarex ... The XTRACT registry aims to enroll up to 600 patients at up to 100 clinical sites across the United States with follow-up at 30 days, 6 months, ...