Enrollment Strategy for Peripheral Arterial Disease

Recruiting in Palo Alto (17 mi)

Overseen byAlexander Fanaroff, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

At least 18 years of age

Have been seen in the University of Pennsylvania Health System

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

+1 more

Exclusion Criteria

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Opt-outExperimental Treatment1 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-inActive Control1 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.