Trial Outcomes & Findings for Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease (NCT NCT04536038)

NCT ID: NCT04536038

Last Updated: 2025-12-24

Results Overview

The proportion of patients that enroll in the GAMEPAD intervention study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5176 participants
• Primary outcome timeframe: Enrollment (period of approximately 6 months)
• Results posted on: 2025-12-24

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	3909	1267
Overall Study COMPLETED	3909	1267
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease

Baseline characteristics by cohort

Measure	Opt-in n=3909 Participants 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 n=1267 Participants 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.	Total n=5176 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 12.3 • n=30 Participants	69.7 years STANDARD_DEVIATION 12 • n=30 Participants	69.6 years STANDARD_DEVIATION 12.2 • n=60 Participants
Sex: Female, Male Female	1589 Participants n=30 Participants	523 Participants n=30 Participants	2112 Participants n=60 Participants
Sex: Female, Male Male	2320 Participants n=30 Participants	744 Participants n=30 Participants	3064 Participants n=60 Participants
Race/Ethnicity, Customized White	2622 Participants n=30 Participants	882 Participants n=30 Participants	3504 Participants n=60 Participants
Race/Ethnicity, Customized Black	916 Participants n=30 Participants	289 Participants n=30 Participants	1205 Participants n=60 Participants
Race/Ethnicity, Customized Asian	62 Participants n=30 Participants	15 Participants n=30 Participants	77 Participants n=60 Participants
Race/Ethnicity, Customized Hispanic	94 Participants n=30 Participants	22 Participants n=30 Participants	116 Participants n=60 Participants
Race/Ethnicity, Customized Other	215 Participants n=30 Participants	59 Participants n=30 Participants	274 Participants n=60 Participants
BMI	29.1 kg/m^2 STANDARD_DEVIATION 6.5 • n=30 Participants	29 kg/m^2 STANDARD_DEVIATION 6.5 • n=30 Participants	29.1 kg/m^2 STANDARD_DEVIATION 6.5 • n=60 Participants
History of myocardial infarction	751 Participants n=30 Participants	204 Participants n=30 Participants	955 Participants n=60 Participants
History of congestive heart failure	1353 Participants n=30 Participants	430 Participants n=30 Participants	1783 Participants n=60 Participants
History of stroke or cerebrovascular event	1421 Participants n=30 Participants	496 Participants n=30 Participants	1917 Participants n=60 Participants
History of dementia	101 Participants n=30 Participants	46 Participants n=30 Participants	147 Participants n=60 Participants
History of pulmonary disease	1408 Participants n=30 Participants	425 Participants n=30 Participants	1833 Participants n=60 Participants
History of Diabetes without complications	1620 Participants n=30 Participants	508 Participants n=30 Participants	2128 Participants n=60 Participants
History of Diabetes with complications	818 Participants n=30 Participants	248 Participants n=30 Participants	1066 Participants n=60 Participants
History of renal disease	1139 Participants n=30 Participants	367 Participants n=30 Participants	1506 Participants n=60 Participants

PRIMARY outcome

Timeframe: 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.

The proportion of patients that enroll in the GAMEPAD intervention study

Outcome measures

Measure	Opt-in n=3909 Participants 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 n=1267 Participants 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.
Enrollment in GAMEPAD Intervention Study	39 Participants	45 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: through the end of the 24-week study period

The proportion of patients enrolled in GAMEPAD that failed to complete the study

Outcome measures

Measure	Opt-in n=39 Participants 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 n=45 Participants 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.
Participants That Fail to Complete Study	.154 proportion of participants	.067 proportion of participants

Adverse Events

Opt-in

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Opt-out

Serious events: 4 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Measure	Opt-in n=3909 participants at risk 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 n=1267 participants at risk 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.
General disorders Other	0.03% 1/3909 • Number of events 1 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.16% 2/1267 • Number of events 3 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
Musculoskeletal and connective tissue disorders Orthopedic	0.00% 0/3909 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.00% 0/1267 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
Cardiac disorders Cardiovascular	0.00% 0/3909 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.16% 2/1267 • Number of events 3 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
Product Issues Fitbit-related	0.00% 0/3909 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.00% 0/1267 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.

Other adverse events

Measure	Opt-in n=3909 participants at risk 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 n=1267 participants at risk 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.
Musculoskeletal and connective tissue disorders Orthopedic	0.20% 8/3909 • Number of events 9 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.32% 4/1267 • Number of events 4 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
Cardiac disorders Cardiovascular	0.03% 1/3909 • Number of events 1 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.16% 2/1267 • Number of events 2 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
Product Issues Fitbit-related	0.03% 1/3909 • Number of events 1 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.08% 1/1267 • Number of events 1 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
General disorders Other	0.20% 8/3909 • Number of events 11 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.	0.39% 5/1267 • Number of events 5 • 24 weeks Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.

Additional Information

Alexander C. Fanaroff, MD, MHS

Hospital of the University of Pennsylvania

Phone: 2156157674

Email: alexander.fanaroff@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place