Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

— GAMEPAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536012
• Other study ID #: 835034
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: January 8, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 8, 2024
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in daily number of minutes engaged in light, moderate, or vigorous physical activity	Change in daily number of minutes engaged in light, moderate, or vigorous physical activity from baseline to the intervention period, and from baseline to the follow-up period	24 Weeks
Other	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.	24 Weeks
Other	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
Other	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
Primary	Change in daily step count	Change in daily step count from baseline to the intervention period	16 Weeks
Secondary	Change in daily step count	Change in daily step count from baseline to the follow-up period	24 Weeks