Peripheral Artery Disease
Conditions
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.
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.
Interventions
BEHAVIORALOpt-out
A study coordinator will call the patient unless they opt-out. See arm description for more details.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment in GAMEPAD Intervention Study | Enrollment (period of approximately 6 months) | The proportion of patients that enroll in the GAMEPAD intervention study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participants That Fail to Complete Study | through the end of the 24-week study period | The proportion of patients enrolled in GAMEPAD that failed to complete the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,909 |
| 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.
Opt-out: A study coordinator will call the patient unless they opt-out. See arm description for more details. | 1,267 |
| Total | 5,176 |
Baseline characteristics
| Characteristic | Opt-in | Opt-out | Total |
|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 12.3 | 69.7 years STANDARD_DEVIATION 12 | 69.6 years STANDARD_DEVIATION 12.2 |
| BMI | 29.1 kg/m^2 STANDARD_DEVIATION 6.5 | 29 kg/m^2 STANDARD_DEVIATION 6.5 | 29.1 kg/m^2 STANDARD_DEVIATION 6.5 |
| History of congestive heart failure | 1353 Participants | 430 Participants | 1783 Participants |
| History of dementia | 101 Participants | 46 Participants | 147 Participants |
| History of Diabetes with complications | 818 Participants | 248 Participants | 1066 Participants |
| History of Diabetes without complications | 1620 Participants | 508 Participants | 2128 Participants |
| History of myocardial infarction | 751 Participants | 204 Participants | 955 Participants |
| History of pulmonary disease | 1408 Participants | 425 Participants | 1833 Participants |
| History of renal disease | 1139 Participants | 367 Participants | 1506 Participants |
| History of stroke or cerebrovascular event | 1421 Participants | 496 Participants | 1917 Participants |
| Race/Ethnicity, Customized Asian | 62 Participants | 15 Participants | 77 Participants |
| Race/Ethnicity, Customized Black | 916 Participants | 289 Participants | 1205 Participants |
| Race/Ethnicity, Customized Hispanic | 94 Participants | 22 Participants | 116 Participants |
| Race/Ethnicity, Customized Other | 215 Participants | 59 Participants | 274 Participants |
| Race/Ethnicity, Customized White | 2622 Participants | 882 Participants | 3504 Participants |
| Sex: Female, Male Female | 1589 Participants | 523 Participants | 2112 Participants |
| Sex: Female, Male Male | 2320 Participants | 744 Participants | 3064 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,909 | 1 / 1,267 |
| other Total, other adverse events | 14 / 3,909 | 11 / 1,267 |
| serious Total, serious adverse events | 1 / 3,909 | 4 / 1,267 |
Outcome results
Primary
Enrollment in GAMEPAD Intervention Study
The proportion of patients that enroll in the GAMEPAD intervention study
Time frame: Enrollment (period of approximately 6 months)
Population: The number of participants reported in the Participant Flow are participants that were active in the GAMEPAD trial. Participants Analyzed above are all the participants randomized to either opt in or opt out recruitment style that was contacted to be a part of the GAMEPAD Study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opt-in | Enrollment in GAMEPAD Intervention Study | 39 Participants |
| Opt-out | Enrollment in GAMEPAD Intervention Study | 45 Participants |
Other Pre-specified
Participants That Fail to Complete Study
The proportion of patients enrolled in GAMEPAD that failed to complete the study
Time frame: through the end of the 24-week study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Opt-in | Participants That Fail to Complete Study | .154 proportion of participants |
| Opt-out | Participants That Fail to Complete Study | .067 proportion of participants |