Social Incentives to Increase Mobility

Diabetes Clinical Trial

— MOVE IT  

Official title:

Social Incentives to Increase Mobility Among Hospitalized Patients: The MOVE IT Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321279
• Other study ID #: 826974
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Diabetes
• Heart Failure
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Social Incentive
Participants in the intervention arm will receive social incentives as part of the intervention. See arm descriptions for more detail.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-day hospital readmission post-discharge, using the state's hospital database	A secondary outcome variable is 30-day hospital readmission post-discharge, which will be obtained from the state-based registry.	13 weeks
Secondary	Functional decline from admission to 3 months post-discharge, measured using validated survey assessments.	A secondary outcome variable is functional decline from admission to 3 months post-discharge, which will be obtained from information collected through validated survey assessments.	13 weeks