Trial · NCT04536038
Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease
NCT04536038, Not applicable, Completed, University of Pennsylvania; results first posted 2025-12-24
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease. Trials, record NCT04536038. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04536038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease
- NCT number
- NCT04536038
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,176 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Peripheral Artery Disease
- Interventions
- Opt-out
- First posted
- 2020-09-02
- Last updated
- 2025-12-24
- Results first posted
- 2025-12-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Enrollment in GAMEPAD Intervention Study | Enrollment (period of approximately 6 months) | The proportion of patients that enroll in the GAMEPAD intervention study |
| Other | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Enrollment in GAMEPAD Intervention Study | Enrollment (period of approximately 6 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Participants That Fail to Complete Study | through the end of the 24-week study period | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Enrollment in GAMEPAD Intervention Study | Opt-in | 39 | Participants | ||
| Enrollment in GAMEPAD Intervention Study | Opt-out | 45 | Participants | ||
| Participants That Fail to Complete Study | Opt-in | .154 | proportion of participants | ||
| Participants That Fail to Complete Study | Opt-out | .067 | proportion of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Opt-in | 3,909 | |
| Overall Study | STARTED | Opt-out | 1,267 | |
| Overall Study | COMPLETED | Opt-in | 3,909 | |
| Overall Study | COMPLETED | Opt-out | 1,267 | |
| Overall Study | NOT COMPLETED | Opt-in | 0 | |
| Overall Study | NOT COMPLETED | Opt-out | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Orthopedic | Musculoskeletal and connective tissue disorders | Opt-in | 8 | 3,909 | 9 |
| other | Orthopedic | Musculoskeletal and connective tissue disorders | Opt-out | 4 | 1,267 | 4 |
| other | Cardiovascular | Cardiac disorders | Opt-in | 1 | 3,909 | 1 |
| other | Cardiovascular | Cardiac disorders | Opt-out | 2 | 1,267 | 2 |
| other | Fitbit-related | Product Issues | Opt-in | 1 | 3,909 | 1 |
| other | Fitbit-related | Product Issues | Opt-out | 1 | 1,267 | 1 |
| other | Other | General disorders | Opt-in | 8 | 3,909 | 11 |
| other | Other | General disorders | Opt-out | 5 | 1,267 | 5 |
| serious | Orthopedic | Musculoskeletal and connective tissue disorders | Opt-in | 0 | 3,909 | 0 |
| serious | Orthopedic | Musculoskeletal and connective tissue disorders | Opt-out | 0 | 1,267 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Opt-in | 0 | 3,909 |
| Total, all-cause mortality | Opt-out | 1 | 1,267 |
| Total, other adverse events | Opt-in | 14 | 3,909 |
| Total, other adverse events | Opt-out | 11 | 1,267 |
| Total, serious adverse events | Opt-in | 1 | 3,909 |
| Total, serious adverse events | Opt-out | 4 | 1,267 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Opt-in vs Opt-out: Enrollment in GAMEPAD Intervention Study | Trial comparisons |
| Opt-in vs Opt-out: deaths from any cause | Trial comparisons |
| Opt-in vs Opt-out: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04536038
GET https://conductscience.org/api/trials/v1/NCT04536038/registered