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Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease

NCT04536038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5176

Last updated 2025-12-24

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Opt-out

A study coordinator will call the patient unless they opt-out. See arm description for more details.

Sponsors & Collaborators

Principal Investigators

  • Alexander Fanaroff, MD, MHS · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2023-05-31
Completion
2024-01-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536038 on ClinicalTrials.gov