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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamification and Social Incentives | Behavioral | Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Step Count | Change in daily step count from baseline to the intervention period (main adjusted model) | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Step Count | Change in daily step count from baseline to the follow-up period (main adjusted model) | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Impairment Questionnaire Score | Change in Walking Impairment Questionnaire score from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. Participants are asked to rate the degree of difficulty of various physical activities, ranging from 0 (unable) to 4 (no difficulty). Scores are divided by the maximum number of points and presented on a scale of 0%-100% where 0% indicates they are unable to do the activity and 100% indicates they have no difficulty. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Fanaroff, MD, MHS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41334739 | Derived | 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. | |
| 38354997 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | Intervention | 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. Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. |
| BG001 | Intervention | 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. Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Daily Step Count | Change in daily step count from baseline to the intervention period (main adjusted model) | Posted | Mean | Standard Deviation | steps per day | 16 Weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthopedic | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthopedic | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander C. Fanaroff, MD, MHS | Hospital of the University of Pennsylvania | 2156157674 | alexander.fanaroff@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2022 | Oct 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 24 Weeks |
| Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | Change in PROMIS (Patient-Reported Outcomes Measurement Information System) mobility, pain interference, and satisfaction with social roles and activities scores from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. In the mobility survey, participants are asked to rate the level of difficulty of various physical activities on a scale from 1 to 5, where 1 means they are unable to do the activity and 5 means they have no difficulty. In the pain interference survey, they are asked to rate the degree to which pain interfered with various activities on a scale from 1 to 5, where 1 indicates pain did not interfere and 5 indicates pain very much interfered. For the satisfaction with social roles, participants are asked to rate how satisfied they are with their ability to perform various activities on a scale of 1-5, where 1 indicates they are not satisfied and 5 indicates they are very satisfied. | 24 Weeks |
| Change in SF-36 Physical Functioning Scale | Change in SF-36 (36-Item Short Form Survey) physical functioning scale from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. Participants are asked to self-report their health using 8 variously scaled scores. The scales are re-coded to values from 0 to 100, with 0 indicating lowest functioning/well-being and 100 indicating the highest. | 24 Weeks |
| Derived |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Annual Household Income | Count of Participants | Participants |
|
| Prior Use of Smartphone or Wearable to Track Steps | Count of Participants | Participants |
|
| Current Smoking | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Prior MI | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Heart Failure | Count of Participants | Participants |
|
| COPD | Count of Participants | Participants |
|
| Kidney Disease | Count of Participants | Participants |
|
| San Diego Claudication Questionnaire | Count of Participants | Participants |
|
| Baseline Daily Step Count | Mean | Standard Deviation | Steps |
|
| Goal Step Increase | Mean | Standard Deviation | Steps |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Change in Daily Step Count | Change in daily step count from baseline to the follow-up period (main adjusted model) | Posted | Mean | Standard Deviation | steps per day | 24 Weeks |
|
|
|
| Other Pre-specified | Change in Walking Impairment Questionnaire Score | Change in Walking Impairment Questionnaire score from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. Participants are asked to rate the degree of difficulty of various physical activities, ranging from 0 (unable) to 4 (no difficulty). Scores are divided by the maximum number of points and presented on a scale of 0%-100% where 0% indicates they are unable to do the activity and 100% indicates they have no difficulty. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 Weeks |
|
|
|
| Other Pre-specified | Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | Change in PROMIS (Patient-Reported Outcomes Measurement Information System) mobility, pain interference, and satisfaction with social roles and activities scores from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. In the mobility survey, participants are asked to rate the level of difficulty of various physical activities on a scale from 1 to 5, where 1 means they are unable to do the activity and 5 means they have no difficulty. In the pain interference survey, they are asked to rate the degree to which pain interfered with various activities on a scale from 1 to 5, where 1 indicates pain did not interfere and 5 indicates pain very much interfered. For the satisfaction with social roles, participants are asked to rate how satisfied they are with their ability to perform various activities on a scale of 1-5, where 1 indicates they are not satisfied and 5 indicates they are very satisfied. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 Weeks |
|
|
|
| Other Pre-specified | Change in SF-36 Physical Functioning Scale | Change in SF-36 (36-Item Short Form Survey) physical functioning scale from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. Participants are asked to self-report their health using 8 variously scaled scores. The scales are re-coded to values from 0 to 100, with 0 indicating lowest functioning/well-being and 100 indicating the highest. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 Weeks |
|
|
|
| 0 |
| 52 |
| 3 |
| 52 |
| 13 |
| 52 |
| EG001 | Intervention | 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. Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail. | 1 | 51 | 6 | 51 | 21 | 51 |
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
|
| Fitbit-related | Product Issues | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Fitbit-related | Product Issues | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| WIQ Stair Climbing |
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| WIQ Overall |
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| Role functioning/emotional |
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| Energy/fatigue |
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| Emotional well-being |
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| Social functioning |
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| Pain |
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| General Health |
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| Health Change |
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