Behavioral Economics and Mobility After Stroke (BE Mobile) (BE Mobile)

September 15, 2021 updated by: University of Pennsylvania

Using Behavioral Economics to Improve Mobility for Adults With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period. Participants will complete study surveys at baseline and the end of the 8 week intervention.
Experimental: Gamification arm
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily step counts
Time Frame: Intervention weeks 1-8
Change in mean daily steps from baseline
Intervention weeks 1-8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily step counts
Time Frame: Intervention weeks 1-8
Proportion of days participants in the gamification arm met their daily step goal
Intervention weeks 1-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Study Director: Kimberly J Waddell, PhD, MS, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

July 12, 2021

Study Completion (Actual)

July 12, 2021

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 843894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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