Enrollment Strategy for Peripheral Arterial Disease
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.12345Why 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.15678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment
Participants are contacted via email to determine their interest in participation and are randomized to opt-in or opt-out framing for enrollment
Intervention
Participants engage in a home-based walking program with automated coaching, augmented with gamification and behavioral economic principles
Follow-up
Participants are monitored for changes in step count and patient-reported symptom scores
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Citations
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.
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.
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 ...
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 ...
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 ...
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.
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.
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, ...
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