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Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT04536038
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Behavioral: Opt-out Not Applicable

Detailed Description:

The GAMEPAD study is a two-arm randomized controlled trial aimed at evaluating whether a home-based walking program with automated coaching augmented with gamification and behavioral economic principles improves functional capacity in patients with PAD. GAMEPAD will be conducted using the Way to Health platform, and patients will enroll and consent for participation online, with available help from a study coordinator by telephone. The present study will leverage the GAMEPAD enrollment process to test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the GAMEPAD study and the demographic characteristics of enrolled patients.

Eligible patients will be contacted via email to determine their interest in participation in the GAMEPAD study. Patients will be randomized 3:1 to an email message framing trial participation in a standard opt-in manner versus an email message framing trial participation in an opt-out manner.

Patients randomized to opt-in framing will be instructed to visit the Way to Health website to enroll in the GAME PAD study, or to call or email the study coordinator with questions or for assistance in enrolling. Patients randomized to opt-out framing will be informed that a study coordinator will be calling them in the coming days to discuss enrollment in the study.

Baseline characteristics of patients randomized to each framing method will be abstracted from the electronic health record and Penn Data Store, and will include age, sex, race/ethnicity, and medical comorbidities. Whether contacted patients created an account on the Way to Health website and/or ultimately consented for enrollment in the study will be captured.

For all outcomes, we will compare patients initially presented with study participation via opt-in framing versus opt-out framing. The primary outcome will be the proportion of patients that enroll in the GAMEPAD study. We will also report the proportion of enrolled patients that failed to complete the GAMEPAD study among those patients that ultimately enrolled.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Effect of opt-in Versus Opt-out Framing on Clinical Trial Enrollment Among Patients With Peripheral Artery Disease
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Opt-in
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.
Experimental: Opt-out
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
A study coordinator will call the patient unless they opt-out. See arm description for more details.


Outcome Measures
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Primary Outcome Measures :
  1. Enrollment in GAMEPAD intervention study [ Time Frame: 6 Months ]
    The proportion of patients that enroll in the GAMEPAD intervention study


Other Outcome Measures:
  1. Participants that fail to complete study [ Time Frame: 12 months ]
    The proportion of patients enrolled in GAMEPAD that failed to complete the study

  2. Change in step count from baseline to end of intervention [ Time Frame: 16 weeks ]
    Change in daily step count from baseline to the end of the GAMEPAD intervention (overall and stratified by overall GAME PAD study arm -gamification intervention versus attention control)

  3. Change in step count from baseline to end of follow-up period [ Time Frame: 24 weeks ]
    Change in daily step count from baseline to the end of follow-up (overall and stratified by overall GAMEPAD study arm -gamification intervention versus attention control)

  4. Change in patient-reported symptom scores from baseline to end of GAMEPAD intervention [ Time Frame: 16 weeks ]
    Change in patient-reported symptom scores from baseline to the end of the GAME PAD intervention (overall and stratified by overall GAMEPAD study arm). The Walking Impairment Questionnaire will be used to rate the degree of difficulty of various physical activities, ranging from 0 (unable) to 4 (no difficulty). Scores are divided by the maximum number of points and presented on a scale of 0%-100% where 0% indicates they are unable to do the activity and 100% indicates they have no difficulty.

  5. Change in patient-reported symptom scores from baseline to end of follow-up period [ Time Frame: 24 weeks ]
    Change in patient-reported symptom scores from baseline to the end of follow-up (overall and stratified by overall GAMEPAD study arm). The Walking Impairment Questionnaire will be used to rate the degree of difficulty of various physical activities, ranging from 0 (unable) to 4 (no difficulty). Scores are divided by the maximum number of points and presented on a scale of 0%-100% where 0% indicates they are unable to do the activity and 100% indicates they have no difficulty.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536038


Contacts
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Contact: Samantha Coratti 7325973650 samantha.coratti@pennmedicine.upenn.edu
Contact: Alexander Fanaroff, MD, MHS

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Catherine Reale    215-746-4009      
Principal Investigator: Alexander Fanaroff, MD, MHS         
Principal Investigator: MItesh Patel, MD, MBA         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Alexander Fanaroff, MD, MHS University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04536038    
Other Study ID Numbers: 842681
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases