Behavioral Economics and Mobility After Stroke (BE Mobile)

Not Applicable

Completed

• Conditions: Stroke

• 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

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