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Completed

NCT Number: NCT04536012

Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Daily Step Count

    Time frame: 16 Weeks

    Change in daily step count from baseline to the intervention period (main adjusted model)

Secondary outcomes

  1. Change in Daily Step Count

    Time frame: 24 Weeks

    Change in daily step count from baseline to the follow-up period (main adjusted model)

Other outcomes

  1. Change in Walking Impairment Questionnaire Score

    Time frame: 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.

  2. Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores

    Time frame: 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.

  3. Change in SF-36 Physical Functioning Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: GAMEPAD

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 2, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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