Clinical trial NCT04607811: Behavioral Economics and Mobility After Stroke (BE Mobile)
Official title: Using Behavioral Economics to Improve Mobility for Adults With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: physical activity
wearable
gamification
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Daily step counts
timeFrame: Intervention weeks 1-8
Secondary outcomes:
measure: Daily step counts
timeFrame: Intervention weeks 1-8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ryan Greysen, MD, MHS, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Kimberly J Waddell, PhD, MS
role: STUDY_DIRECTOR
References:
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.