Behavioral Economics and Mobility After Stroke (BE Mobile)

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Gamification with social incentives

• Registration Number: NCT04607811
• Lead Sponsor: University of Pennsylvania

Brief Summary

In this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke.

Detailed Description

In this 2 arm randomized trial, the investigators will compare the preliminary effectiveness of a social incentive-based gamification intervention to increase physical activity relative to a control arm among adults with stroke. All participants will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above their baseline and then participate in an 8 week intervention. The gamification arm will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game.

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-29
• Study Start: 2020-11-16
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• History of ischemic or hemorrhagic stroke (confirmed with ICD-10 or DRG code) at least 3 months prior to enrollment
• Ability to provide informed consent
• Life Space Assessment mobility level 3
• Ability to ambulate outside of their home (self-reported)
• Owns a smartphone or tablet compatible with required applications for the wearable tracking device
• Sufficient cognitive ability to participate (5-minute Montreal Cognitive Assessment Score ≥ 11 points)

Exclusion Criteria

• Inability to provide informed consent, illiteracy or inability to speak, read, and write English
• Self-reported history of falls within the last 3 months
• Severe cognitive impairment (MoCA score ≤ 10 points)
• Medical condition that may limit participation in physical activity program (e.g. metastatic cancer, end-stage renal disease)
• Currently institutionalized in skilled nursing or long-term care facility
• Baseline step count > 7500/day
• Currently receiving physical therapy services

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamification arm	Gamification with social incentives	Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period. Participants will have a weekly step goal they are encouraged to meet. Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. Participants will receive daily feedback for the step counts and weekly feedback for levels. Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance.

Primary Outcome Measures

Name	Time	Method
Daily step counts	Intervention weeks 1-8	Change in mean daily steps from baseline

Secondary Outcome Measures

Name	Time	Method
Daily step counts	Intervention weeks 1-8	Proportion of days participants in the gamification arm met their daily step goal

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States