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Enrollment Strategy for Peripheral Arterial Disease

N/A

Waitlist Available

Led By Alexander Fanaroff, MD, MHS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill explore how opt-in or opt-out wording affects patients with PAD enrolling in a physical activity study.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on participation framing rather than medical interventions, it does not involve direct side effects from drugs or treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment in GAMEPAD intervention study

Other study objectives

Change in patient-reported symptom scores from baseline to end of GAMEPAD intervention

Change in patient-reported symptom scores from baseline to end of follow-up period

Change in step count from baseline to end of follow-up period

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Opt-out

2020

N/A

~620

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