Peripheral Artery DiseaseNCT04536038
Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease
A study testing Opt-out in people with Peripheral Artery Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Opt-out
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,176 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previously indicated unwillingness to be contacted by email for participation in research studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effect of opt-in Versus Opt-out Framing on Clinical Trial Enrollment Among Patients With Peripheral Artery Disease
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Opt-out
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-outBehavioural
A study coordinator will call the patient unless they opt-out. See arm description for more details.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Opt-out |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in GAMEPAD Intervention Study
The proportion of patients that enroll in the GAMEPAD intervention study
Measured: Enrollment (period of approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start5 Oct 2020
- Primary completion31 May 2023
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Fanaroff, MD, MHS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536038
- Sponsor's protocol ID
- 842681
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2020
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of opt-in Versus Opt-out Framing on Clinical Trial Enrollment Among Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04536038
- Acronym / sponsor ID
- 842681
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,176 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Posted 24 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Opt-outPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Previously indicated unwillingness to be contacted by email for participation in research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opt-outA study coordinator will call the patient unless they opt-out. See arm description for more details. | Behavioural | Opt-out |
Primary outcome
Enrollment in GAMEPAD Intervention Study
Time frame: Enrollment (period of approximately 6 months)
The proportion of patients that enroll in the GAMEPAD intervention study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peripheral Artery Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Fanaroff, MD, MHS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-out in people with Peripheral Artery Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in GAMEPAD Intervention Study (time frame: Enrollment (period of approximately 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.