Behavioral Economics and Mobility After Stroke (BE Mobile)

Stroke Clinical Trial

— BE Mobile  

Official title:

Using Behavioral Economics to Improve Mobility for Adults With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607811
• Other study ID #: 843894
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: July 12, 2021

Study information

• Verified date: September 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Gamification with social incentives
Participants will select a step goal that is 33%, 40%, or 50% above their baseline step value. Participants in this group will participate in a game with points and levels to help motivate participants to meet their daily step goal. Additionally, all participants will identify a support partner to receive weekly updates on their performance and offer positive encouragement to help the participant meet their step goal.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily step counts	Change in mean daily steps from baseline	Intervention weeks 1-8
Secondary	Daily step counts	Proportion of days participants in the gamification arm met their daily step goal	Intervention weeks 1-8