Behavioral Economics and Mobility After Stroke (BE Mobile)

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT04607811
Collaborator
(none)
34
1
2
7.8
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gamification with social incentives
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Using Behavioral Economics to Improve Mobility for Adults With Stroke
Actual Study Start Date :
Nov 16, 2020
Actual Primary Completion Date :
Jul 12, 2021
Actual Study Completion Date :
Jul 12, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Daily step counts [Intervention weeks 1-8]

    Change in mean daily steps from baseline

Secondary Outcome Measures

  1. Daily step counts [Intervention weeks 1-8]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

  • Principal Investigator: Ryan Greysen, MD, MHS, MA, University of Pennsylvania
  • Study Director: Kimberly J Waddell, PhD, MS, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04607811
Other Study ID Numbers:
  • 843894
First Posted:
Oct 29, 2020
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021