Clinical trial NCT03321279: Social Incentives to Increase Mobility
Official title: Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Diabetes
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 233
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: This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge.

Detailed description: This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge. To do this, the investigators will conduct a two-arm randomized, controlled trial during the 3-months after hospital discharge comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled during hospitalization from medicine and oncology floors into three phases. In phase 1 (hospitalization), patients inpatient step counts will be monitored. In phase 2 (week 1 post-discharge), patients will have a baseline step count estimated. In phase 3 (weeks 2-13 post-discharge), patients will be randomly assigned to the control or intervention group. Patients will be considered enrolled in the trial if they complete the run-in periods (phases 1 and 2) and then are randomized into phase 3.

The enrollment phase will be part of another randomized trial which evaluates the impact of three recruitment strategies on patient enrollment. This trial will be completed and unmasked to patients before they begin the phase 1 of our study.

The investigators will also explore patients' physical activity while in the hospital and if that differs across floors that have or have not deployed a nursing mobility protocol. Changes in patient functional decline and 30-day hospital readmission will also be explored.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Admitted to medicine or oncology floor in the hospital

Exclusion Criteria:

* Inability to provide informed consent
* Does not have daily access to a smartphone compatible with the wearable device
* Already enrolled in another physical activity program
* Inpatient mobility score of 0 or 1 indicating that physical activity is not appropriate for the patient
* Any other medical conditions that would prohibit participation in a 3-month physical activity program
* Unable to complete the run-in phases (e.g. not discharged from the hospital within 60 days of enrolling; not willing to use the wearable device for the 3-month post-discharge intervention).

Primary outcomes:
measure: Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count.
timeFrame: 13 weeks
Secondary outcomes:
measure: 30-day hospital readmission post-discharge, using the state's hospital database
timeFrame: 13 weeks
measure: Functional decline from admission to 3 months post-discharge, measured using validated survey assessments.
timeFrame: 13 weeks
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: Mitesh Patel, MD, MBA, MS
role: STUDY_DIRECTOR
References:
citation: Greysen SR, Waddell KJ, Patel MS. Exploring Wearables to Focus on the "Sweet Spot" of Physical Activity and Sleep After Hospitalization: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Apr 27;10(4):e30089. doi: 10.2196/30089.
citation: Greysen SR, Changolkar S, Small DS, Reale C, Rareshide CAL, Mercede A, Snider CK, Greysen HM, Trotta R, Halpern SD, Patel MS. Effect of Behaviorally Designed Gamification With a Social Support Partner to Increase Mobility After Hospital Discharge: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210952. doi: 10.1001/jamanetworkopen.2021.0952.
citation: Greysen HM, Reale C, Mercede A, Patel MS, Small D, Snider C, Rareshide C, Halpern SD, Greysen SR. Mobility and outcomes for validated evidence - Incentive trial (MOVE IT): Randomized clinical trial study protocol. Contemp Clin Trials. 2020 Feb;89:105911. doi: 10.1016/j.cct.2019.105911. Epub 2019 Dec 12. No abstract available.