Peripheral Artery DiseaseGAMEPADNCT04536012

Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

A study testing Gamification and Social Incentives in people with Peripheral Artery Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease
What is being tested?: Gamification and Social Incentives
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 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
Peripheral artery disease, defined as ankle-brachial index < 0.90, lower extremity CT scan or ultrasound consistent with PAD, angiography with ≥ 70% stenosis in any lower extremity artery, or a history of medical or surgical revascularization
Owns a smartphone or tablet operating the iOS or Android operating system

Who cannot join

Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
Critical limb ischemia, defined as rest pain, ulceration, or tissue loss involving the lower extremity
Planned lower extremity revascularization
Prior above or below the knee amputation
Require a wheelchair or the use of a walking aid other than a cane
Currently participating in a supervised exercise program for patients with PAD

Show all 9Show fewer

Anticipated life expectancy less than 6 months
Any other reason why it is not feasible to complete the entire 6-month study
Step count > 7500/day during the baseline data collection period

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease (GAMEPAD)

A randomized trial of a gamification-enhanced home-based walking program compared with a standard home-based walking program in patients with intermittent claudication. Patients will be provided with a Fitbit device and set an exercise goal. Over the next 16 weeks, patients will receive text message reminders to exercise and daily steps will be tracked. Half of patients will be randomized to a gamified interface that leverages behavioral economic principles to encourage exercise.

Read the detailed description

Peripheral artery disease, atherosclerotic vascular disease involving the lower extremities, leads to functional limitation by causing leg pain with ambulation (intermittent claudication). Supervised exercise programs improve walking endurance in patients with intermittent claudication, but many patients are unable to travel to centers for treatment. In a recent trial, a home-based exercise program using wearable fitness trackers and telephone coaching failed to increase walking distance in patients with intermittent claudication, but this intervention did not leverage gamification or health behavior theory. Therefore, a randomized controlled trial was proposed comparing a gamification-enhanced home-based walking program with an attention control in patients with intermittent claudication. Patients in both arms will be provided with a wearable fitness tracker, wear the tracker for 2 weeks to establish a baseline daily step count and set a goal for step increase by the end of the 16-week study period. Patients in the attention control arm will receive daily text messages with a report of their previous day's step count. Patients in the gamification intervention arm will receive automated coaching via daily text messages and the intervention will also involve a precommittment pledge, slow ramp-up of step goals, weekly progression (or regression) through levels with loss-framing of points, and support from a family member or friend. After 16 weeks, change in daily step counts from baseline will be compared between study arms. Secondary behavioral phenotyping analyses will be undertaken to identify psychometric features associated with response to the gamification intervention.

Conditions: Peripheral Artery Disease
Being tested: Gamification and Social Incentives
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.

Gamification and Social IncentivesBehavioural
Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.

Study groups in NCT04536012
Study group	Role	What they receive
Control	No intervention	Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
Intervention	Experimental	Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise. Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level. In the follow-up period, participants continue to get a daily text stating if they met their step goal. Receives: Behavioral: Gamification and Social Incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Daily Step Count
Change in daily step count from baseline to the intervention period (main adjusted model)
Measured: 16 Weeks

Secondary outcomes (1)

Change in Daily Step Count
Change in daily step count from baseline to the follow-up period (main adjusted model)
Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 20208 Jan 2024

First posted2 Sep 2020
Study start5 Oct 2020
Primary completion14 Nov 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.
Publications (2)Papers the sponsor has linked to this study.
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: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04536012
Sponsor's protocol ID: 835034
Acronym: GAMEPAD
Status last verified: Jan 2025
First submitted: 27 Aug 2020
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fanaroff AC, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Levin MG, Damrauer SM, Giri JS, Chokshi NP, Jackson BM, Patel MS. Effect of Gamification Plus Automated Coaching to Increase Physical Activity Among Patients With Peripheral Artery Disease: The GAMEPAD Randomized Controlled Trial. J Am Heart Assoc. 2025 Dec 16;14(24):e038921. doi: 10.1161/JAHA.124.038921. Epub 2025 Dec 3.
PubMed 41334739
Fanaroff AC, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Levin MG, Damrauer SM, Giri JS, Chokshi NP, Jackson BM, Patel MS. Gamification-augmented home-based exercise for peripheral artery disease: Rationale and design of the GAMEPAD Study. Am Heart J. 2024 Apr;270:95-102. doi: 10.1016/j.ahj.2024.02.003. Epub 2024 Feb 13.
PubMed 38354997

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease (GAMEPAD)
ClinicalTrials.gov ID: NCT04536012
Acronym / sponsor ID: GAMEPAD / 835034
Conditions: Peripheral Artery Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 5 Oct 2020 (actual)
Primary completion: 14 Nov 2023 (actual)
Study completion: 8 Jan 2024 (actual)
First posted: 2 Sep 2020 (actual)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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
Control	No intervention	–Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
Intervention	Experimental	Behavioral: Gamification and Social IncentivesParticipants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise. Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level. In the follow-up period, participants continue to get a daily text stating if they met their step goal.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 18 years of age
Peripheral artery disease, defined as ankle-brachial index < 0.90, lower extremity CT scan or ultrasound consistent with PAD, angiography with ≥ 70% stenosis in any lower extremity artery, or a history of medical or surgical revascularization
Owns a smartphone or tablet operating the iOS or Android operating system

Key exclusion criteria (9 listed)

Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
Critical limb ischemia, defined as rest pain, ulceration, or tissue loss involving the lower extremity
Planned lower extremity revascularization
Prior above or below the knee amputation
Require a wheelchair or the use of a walking aid other than a cane

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
Gamification and Social IncentivesParticipants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.	Behavioural	Intervention

Primary outcome

Change in Daily Step Count
Time frame: 16 Weeks
Change in daily step count from baseline to the intervention period (main adjusted model)

1 secondary outcome

Change in Daily Step Count
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	52	51
Intervention	51	45

Primary outcome: Change in Daily Step Count

Time frame: 16 Weeks. Mean (Standard Deviation). Unit: steps per day

Measure	Control n = 52	Intervention n = 51
Value	783 (2441)	1770 (2481)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	3 of 52 (5.8%)	13 of 52 (25%)	0 of 52
Intervention	6 of 51 (11.8%)	21 of 51 (41.2%)	1 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41334739Fanaroff AC, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Levin MG, Damrauer SM, Giri JS, Chokshi NP, Jackson BM, Patel MS. Effect of Gamification Plus Automated Coaching to Increase Physical Activity Among Patients With Peripheral Artery Disease: The GAMEPAD Randomized Controlled Trial. J Am Heart Assoc. 2025 Dec 16;14(24):e038921. doi: 10.1161/JAHA.124.038921. Epub 2025 Dec 3.
Derived from this study: PubMed 38354997Fanaroff AC, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Levin MG, Damrauer SM, Giri JS, Chokshi NP, Jackson BM, Patel MS. Gamification-augmented home-based exercise for peripheral artery disease: Rationale and design of the GAMEPAD Study. Am Heart J. 2024 Apr;270:95-102. doi: 10.1016/j.ahj.2024.02.003. Epub 2024 Feb 13.
Individual participant dataSharing planned: No

Related trials for Peripheral Artery Disease

Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

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 Gamification and Social Incentives 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 3 inclusion and 9 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 4 Feb 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 4 Feb 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?

Change in Daily Step Count (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536012, which also lists 2 linked publications.

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 4 Feb 2025.