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

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

It is uncertain whether opt-out framing will increase participation in a clinical trial intended to promote physical activity in patients with peripheral artery disease (PAD). This study will test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the study and the demographic characteristics of enrolled patients.

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+