Behavioral Economics and Mobility After Stroke (BE Mobile)

NCT04607811 | Completed

• 1 other identifier: 843894
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

physical activity; wearable; gamification

Outcome Measures

Primary Outcomes (1)

• Daily step counts

  Change in mean daily steps from baseline

  Intervention weeks 1-8

Secondary Outcomes (1)

• Daily step counts

  Intervention weeks 1-8

Study Arms (2)

Control arm

NO INTERVENTION

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.

Gamification arm

EXPERIMENTAL

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

Interventions

Gamification with social incentives BEHAVIORAL

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.

Gamification arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 34129953 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Ryan Greysen, MD, MHS, MA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kimberly J Waddell, PhD, MS

  University of Pennsylvania

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: November 16, 2020
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)