Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease

NCT04536038 | Completed Results

• 1 other identifier: 842681
• Study Type: interventional
• Target: 5,176
• Locations: 1 country
• Sites: 1

Brief 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

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Enrollment in GAMEPAD Intervention Study

  The proportion of patients that enroll in the GAMEPAD intervention study

  Enrollment (period of approximately 6 months)

Other Outcomes (1)

• Participants That Fail to Complete Study

  through the end of the 24-week study period

Study Arms (2)

Opt-in

NO 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.

Opt-out

EXPERIMENTAL

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.

Behavioral: Opt-out

Interventions

Opt-out BEHAVIORAL

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

Opt-out

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previously indicated unwillingness to be contacted by email for participation in research studies

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Alexander C. Fanaroff, MD, MHS
• Organization: Hospital of the University of Pennsylvania

alexander.fanaroff@pennmedicine.upenn.edu

2156157674

Study Officials

• Alexander Fanaroff, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: October 5, 2020
• Primary Completion: May 31, 2023
• Study Completion: January 8, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)