Peripheral Artery Disease
Conditions
Brief summary
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.
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.
Interventions
BEHAVIORALGamification 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.
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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Step Count | 16 Weeks | Change in daily step count from baseline to the intervention period (main adjusted model) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Step Count | 24 Weeks | Change in daily step count from baseline to the follow-up period (main adjusted model) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Impairment Questionnaire Score | 24 Weeks | 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. |
| Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | 24 Weeks | 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. |
| Change in SF-36 Physical Functioning Scale | 24 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. | 51 |
| Total | 103 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 9.1 | 69.7 years STANDARD_DEVIATION 8.6 | 69.4 years STANDARD_DEVIATION 8.2 |
| Annual Household Income > $100,000 | 16 Participants | 34 Participants | 18 Participants |
| Annual Household Income < $50,000 | 17 Participants | 35 Participants | 18 Participants |
| Annual Household Income $50,000 to $100,000 | 19 Participants | 34 Participants | 15 Participants |
| Baseline Daily Step Count | 4540 Steps STANDARD_DEVIATION 2379 | 4367 Steps STANDARD_DEVIATION 2039 | 4191 Steps STANDARD_DEVIATION 1627 |
| BMI | 29.4 kg/m^2 STANDARD_DEVIATION 7.2 | 30.1 kg/m^2 STANDARD_DEVIATION 6.4 | 30.8 kg/m^2 STANDARD_DEVIATION 5.4 |
| COPD | 7 Participants | 19 Participants | 12 Participants |
| Current Smoking | 7 Participants | 11 Participants | 4 Participants |
| Diabetes | 17 Participants | 37 Participants | 20 Participants |
| Education College Graduate | 32 Participants | 54 Participants | 22 Participants |
| Education High School Graduate | 7 Participants | 14 Participants | 7 Participants |
| Education Some College | 11 Participants | 33 Participants | 22 Participants |
| Education Some High School | 2 Participants | 2 Participants | 0 Participants |
| Education College graduate | 32 Participants | 54 Participants | 22 Participants |
| Education High school graduate | 7 Participants | 14 Participants | 7 Participants |
| Education Some college | 11 Participants | 33 Participants | 22 Participants |
| Education Some high school | 2 Participants | 2 Participants | 0 Participants |
| Goal Step Increase | 1160 Steps STANDARD_DEVIATION 2033 | 1353 Steps STANDARD_DEVIATION 1541 | 1549 Steps STANDARD_DEVIATION 740 |
| Heart Failure | 7 Participants | 12 Participants | 5 Participants |
| Hyperlipidemia | 37 Participants | 73 Participants | 36 Participants |
| Hypertension | 37 Participants | 83 Participants | 46 Participants |
| Kidney Disease | 10 Participants | 20 Participants | 10 Participants |
| Marital Status Married | 27 Participants | 57 Participants | 30 Participants |
| Marital Status Other | 17 Participants | 27 Participants | 10 Participants |
| Marital Status Single | 8 Participants | 19 Participants | 11 Participants |
| Prior MI | 16 Participants | 26 Participants | 10 Participants |
| Prior Use of Smartphone or Wearable to Track Steps | 35 Participants | 62 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 16 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 81 Participants | 39 Participants |
| Region of Enrollment United States | 52 Participants | 103 Participants | 51 Participants |
| San Diego Claudication Questionnaire Atypical Leg Pain | 26 Participants | 53 Participants | 27 Participants |
| San Diego Claudication Questionnaire Classic Claudication | 9 Participants | 21 Participants | 12 Participants |
| San Diego Claudication Questionnaire No Symptoms | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Female | 27 Participants | 49 Participants | 22 Participants |
| Sex: Female, Male Male | 25 Participants | 54 Participants | 29 Participants |
| Stroke | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 1 / 51 |
| other Total, other adverse events | 13 / 52 | 21 / 51 |
| serious Total, serious adverse events | 3 / 52 | 6 / 51 |
Outcome results
Primary
Change in Daily Step Count
Change in daily step count from baseline to the intervention period (main adjusted model)
Time frame: 16 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Daily Step Count | 783 steps per day | Standard Deviation 2441 |
| Intervention | Change in Daily Step Count | 1770 steps per day | Standard Deviation 2481 |
Secondary
Change in Daily Step Count
Change in daily step count from baseline to the follow-up period (main adjusted model)
Time frame: 24 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Daily Step Count | 717 steps per day | Standard Deviation 2410 |
| Intervention | Change in Daily Step Count | 1786 steps per day | Standard Deviation 2476 |
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.
Time frame: 24 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | PROMIS Pain | -2.2 units on a scale |
| Control | Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | PROMIS Social Function | -0.6 units on a scale |
| Intervention | Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | PROMIS Pain | -4.7 units on a scale |
| Intervention | Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores | PROMIS Social Function | 0.3 units on a scale |
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.
Time frame: 24 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Change in SF-36 Physical Functioning Scale | Physical functioning | 0.3 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Emotional well-being | 0.9 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Role functioning/emotional | 5.7 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Social functioning | 7.4 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Role functioning/physical | 5.9 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Pain | 3.5 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Energy/fatigue | 3 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | General Health | 1.2 units on a scale |
| Control | Change in SF-36 Physical Functioning Scale | Health Change | 5.3 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | General Health | 4.2 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Health Change | 16.9 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Physical functioning | 6.7 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Role functioning/physical | 12.8 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Role functioning/emotional | 3.9 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Energy/fatigue | 3 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Emotional well-being | 2.4 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Social functioning | 2 units on a scale |
| Intervention | Change in SF-36 Physical Functioning Scale | Pain | 10.5 units on a scale |
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.
Time frame: 24 Weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Change in Walking Impairment Questionnaire Score | WIQ Stair Climbing | 6.4 units on a scale |
| Control | Change in Walking Impairment Questionnaire Score | WIQ Overall | 1.4 units on a scale |
| Control | Change in Walking Impairment Questionnaire Score | WIQ Distance | -3.8 units on a scale |
| Control | Change in Walking Impairment Questionnaire Score | WIQ Speed | 1.7 units on a scale |
| Intervention | Change in Walking Impairment Questionnaire Score | WIQ Overall | 5.7 units on a scale |
| Intervention | Change in Walking Impairment Questionnaire Score | WIQ Speed | 4.8 units on a scale |
| Intervention | Change in Walking Impairment Questionnaire Score | WIQ Stair Climbing | 9.5 units on a scale |
| Intervention | Change in Walking Impairment Questionnaire Score | WIQ Distance | 7.3 units on a scale |