Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

Overview

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.

Full Title of Study: “Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease (GAMEPAD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2021

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

  • 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.

Arms, Groups and Cohorts

  • No Intervention: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in daily step count
    • Time Frame: 16 Weeks
    • Change in daily step count from baseline to the intervention period

Secondary Measures

  • Change in daily step count
    • Time Frame: 24 Weeks
    • Change in daily step count from baseline to the follow-up period

Participating in This Clinical Trial

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 – Exertional lower extremity symptoms – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexander Fanaraff, MD, MHS, Principal Investigator, University of Pennsylvania
  • Overall Contact(s)
    • Catherine Reale, 215-746-4009, catherine.reale@pennmedicine.upenn.edu

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