NCT03321279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

October 4, 2017

Last Update Submit

July 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in mean daily step count from the baseline period to the intervention period, using a wearable pedometer (Nokia Steel) to measure step count.

    The primary outcome variable is the change in mean daily step count from the baseline period (week 1 post-discharge) to the intervention period (weeks 2-13 post-discharge). This will be measured using the Nokia Steel wearable device. .

    13 weeks

Secondary Outcomes (2)

  • 30-day hospital readmission post-discharge, using the state's hospital database

    13 weeks

  • Functional decline from admission to 3 months post-discharge, measured using validated survey assessments.

    13 weeks

Study Arms (2)

Control

NO INTERVENTION

Participants' daily step counts will be for weeks 2-13 after hospital discharge. Participants will be asked to complete surveys at 5, 9 and 13 weeks post-discharge.

Intervention

EXPERIMENTAL

Participants' daily step counts will be monitored for weeks 2-13 after hospital discharge. Participants will have a weekly step goal that increases from baseline by 10% each week of the intervention (12 weeks). 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: Social Incentive

Interventions

Participants in the intervention arm will receive social incentives as part of the intervention. See arm descriptions for more detail.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • Willinger CM, Waddell KJ, Arora V, Patel MS, Ryan Greysen S. Patient-reported sleep and physical function during and after hospitalization. Sleep Health. 2024 Apr;10(2):249-254. doi: 10.1016/j.sleh.2023.12.001. Epub 2023 Dec 26.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

PneumoniaDiabetes MellitusHeart FailurePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ryan Greysen, MD, MHS, MA

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Mitesh Patel, MD, MBA, 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 4, 2017

First Posted

October 25, 2017

Study Start

January 11, 2018

Primary Completion

September 9, 2019

Study Completion

September 9, 2019

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations