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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gamification with social incentives

About this trial

This is an interventional health services research trial for Stroke focused on measuring physical activity, wearable, gamification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Gamification arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Daily step counts

Change in mean daily steps from baseline

Secondary Outcome Measures

Daily step counts

Proportion of days participants in the gamification arm met their daily step goal

Full Information

NCT ID

NCT04607811

First Posted

October 22, 2020

Last Updated

September 15, 2021

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT04607811

Brief Title

Behavioral Economics and Mobility After Stroke (BE Mobile)

Acronym

BE Mobile

Official Title

Using Behavioral Economics to Improve Mobility for Adults With Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

November 16, 2020 (Actual)

Primary Completion Date

July 12, 2021 (Actual)

Study Completion Date

July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

physical activity, wearable, gamification

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Arm Title

Gamification arm

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Gamification with social incentives

Intervention Description

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.

Primary Outcome Measure Information:

Title

Daily step counts

Description

Change in mean daily steps from baseline

Time Frame

Intervention weeks 1-8

Secondary Outcome Measure Information:

Title

Daily step counts

Description

Proportion of days participants in the gamification arm met their daily step goal

Time Frame

Intervention weeks 1-8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Greysen, MD, MHS, MA

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kimberly J Waddell, PhD, MS

Organizational Affiliation

University of Pennsylvania

Official's Role

Study Director

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34129953

Citation

Waddell KJ, Patel MS, Clark K, Harrington TO, Greysen SR. Leveraging insights from behavioral economics to improve mobility for adults with stroke: Design and rationale of the BE Mobile clinical trial. Contemp Clin Trials. 2021 Aug;107:106483. doi: 10.1016/j.cct.2021.106483. Epub 2021 Jun 12.

Results Reference

derived

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Behavioral Economics and Mobility After Stroke (BE Mobile)

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