Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

NCT04536012 | Completed Results

• 1 other identifier: 835034
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change in Daily Step Count

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

  16 Weeks

Secondary Outcomes (1)

• Change in Daily Step Count

  24 Weeks

Other Outcomes (3)

• Change in Walking Impairment Questionnaire Score

  24 Weeks

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

  24 Weeks

• Change in SF-36 Physical Functioning Scale

  24 Weeks

Study Arms (2)

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.

Behavioral: Gamification and Social Incentives

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 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. 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.

  PMID: 38354997 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Alexander C. Fanaroff, MD, MHS
• Organization: Hospital of the University of Pennsylvania

alexander.fanaroff@pennmedicine.upenn.edu

2156157674

Study Officials

• Alexander Fanaroff, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: October 5, 2020
• Primary Completion: November 14, 2023
• Study Completion: January 8, 2024
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)