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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
Have an ICD-10 code consistent with peripheral artery disease (I70.2x, I70.3x-I70.7x, I73.9) or peripheral artery disease on their problem list
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a medical diagnosis of peripheral artery disease listed in your medical records.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment in GAMEPAD intervention study
Other outcome measures
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

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
1,992 Previous Clinical Trials
42,874,160 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
202 Patients Enrolled for Peripheral Arterial Disease
Alexander Fanaroff, MD, MHSPrincipal InvestigatorUniversity of Pennsylvania
5 Previous Clinical Trials
3,236 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
103 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment window for this clinical trial still open?

"According to clinicaltrials.gov, this trial is actively enrolling participants at the moment; it was initially posted on October 5th 2020 and recently modified on October 12th 2022."

Answered by AI

What is the estimated participant size of this clinical experiment?

"Confirmed. According to clinicaltrials.gov, this medical study began recruiting on October 5th 2020 and is still actively seeking participants as of October 12th 2022. Enrollment requires 1200 individuals from a single site."

Answered by AI
~272 spots leftby Mar 2025