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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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,072 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
202 Patients Enrolled for Peripheral Arterial Disease
Alexander Fanaroff, MD, MHSPrincipal InvestigatorUniversity of Pennsylvania
6 Previous Clinical Trials
3,506 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
103 Patients Enrolled for Peripheral Arterial Disease