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Clinical Trials/NCT05736484
NCT05736484
Active, not recruiting
Not Applicable

The MOVE ON Trial: A Randomized Trial of Gamification and Coaching to Improve Mobility After Hospitalization

University of Pennsylvania2 sites in 1 country350 target enrollmentSeptember 19, 2023

Overview

Phase
Not Applicable
Intervention
Control
Conditions
Hypertension
Sponsor
University of Pennsylvania
Enrollment
350
Locations
2
Primary Endpoint
Change in mean daily step count from baseline to the end of the 26 week intervention period.
Status
Active, not recruiting
Last Updated
26 days ago

Overview

Brief Summary

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) to increase physical activity after hospital discharge to reduce incident mobility disability among older adults.

Detailed Description

MOVE ON is a 2-arm, randomized trial enrolling older adults 50 years or older with a recent hospitalization for hypertension, diabetes, and mild-moderate heart failure. The 52 week trial compares a control group wearing a wearable activity tracker to the intervention group that uses the same device and receives a supportive social incentive-based gamification intervention. The primary goal is to increase physical activity after discharge from the hospital to reduce incident mobility disability associated with acute illness and to reduce acute and post-acute care utilization.

Registry
clinicaltrials.gov
Start Date
September 19, 2023
End Date
July 1, 2026
Last Updated
26 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 50 years or older
  • Admitted to the University of Pennsylvania Health System acute care hospital (Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Pennsylvania Hospital, Lancaster General Health, Chester County Hospital, or Penn Medicine Princeton Medical Center) and discharged to home
  • Able to ambulate independently

Exclusion Criteria

  • Inability to provide informed consent
  • Does not have daily access to a smartphone compatible with the wearable device and is not willing to use a device that the investigators can provide participants' with
  • Already enrolled in another physical activity study
  • Low mobility score indicating that the patient is not able to walk distances greater than 1000 steps/day independently
  • Any other medical conditions that would prohibit participation in a 6-month physical activity program
  • Unable to complete the baseline period (must have at least 4 out of 7 days of step data with minimum step count of 1000 steps/day)
  • Not willing to use the wearable device for the full duration of the study
  • Enrolled in hospice

Arms & Interventions

Control

Participants will receive a wearable device (e.g. FitBit) but no other interventions during the intervention or follow-up periods.Participants will complete milestones within the study, such as the Function assessment during the 6, and 12-month timepoints in the study. They will also complete a series of surveys during the 3, 6, 9, and 12-month timepoints in the study. Participants will complete an end-of-study questionnaire on their experience with the wearable device and time in the study.

Social Support Gamification

Intervention participants will receive a wearable device (e.g. FitBit) and will enter a game designed with behavioral economics concepts to address predictable barriers to behavior change during a 26-week intervention period. Participants will also work with a virtual health coach throughout the intervention period to increase their physical activity. At the end of the 26 week intervention period, participants will enter a 26 week follow-up period during which interventions will cease but passive data collection of step counts will continue. Participants will also complete milestones within the study, such as the Function assessment during the 6, and 12-month timepoints in the study. They will also complete a series of surveys during the 3, 6, 9, and 12-month timepoints in the study. Participants will complete an end-of-study questionnaire on their experience with the wearable device and time in the study.

Intervention: Social Support Gamification

Outcomes

Primary Outcomes

Change in mean daily step count from baseline to the end of the 26 week intervention period.

Time Frame: Baseline to 26 week intervention period (Weeks 1-26)

The primary outcome of the study is the participants' change in mean daily steps from the baseline period to the end of the 26 week intervention period collected by Fitbit Inspire device.

Secondary Outcomes

  • Participants' acute care utilization throughout the entire study (Baseline to end of study [52 weeks]).(Baseline to 26 and 52 weeks- end of the study (Weeks 1-52))
  • Participants' mobility disability throughout the entire study (Baseline to end of study [52 weeks]).(Baseline to 26 and 52 weeks- end of the study (Weeks 1-52))
  • Change in mean daily step count from baseline to the end of the 26 week follow-up period.(Baseline to 52 weeks- end of the study (Weeks 1-52))

Study Sites (2)

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