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N/A Completed N=5,176 Randomized Double-blind Health Services Research

Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease

Source: ClinicalTrials.gov NCT04536038 ↗
Enrolled (actual)
5,176
Serious AEs
0.1%
Results posted
Dec 2025
Primary outcomePrimary: Enrollment in GAMEPAD Intervention Study — 39; 45 Participants

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Enrollment in GAMEPAD Intervention Study
39; 45

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age
  • Have been seen in the University of Pennsylvania Health System
  • 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
  • Have an email address on file with the University of Pennsylvania Health System

Exclusion Criteria

  • Previously indicated unwillingness to be contacted by email for participation in research studies
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04536038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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