Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition

This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge.

Study Overview

• Status: Completed
• Conditions: Physical Medicine
• Intervention / Treatment: Behavioral: Ambulation; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admitted to acute inpatient medicine unit
• Ambulatory without assistive device prior to hospitalization
• Medical clearance to ambulate on the unit
• Active MyChart account or willing to activate MyChart account
• iOS or Android device

Exclusion Criteria:

• Patients less than or equal to 65 years old
• Not Admitted to acute inpatient medicine unit
• Ambulatory with assistive device prior to hospitalization
• No Medical clearance to ambulate on the unit
• Inactive MyChart account and not willing to activate MyChart account
• No iOS or Android device

In addition, an individual who meets any of the following criteria will be excluded from participation in this study:

• Oxygen requirement at rest
• Lower extremity prosthesis
• Admitted for joint replacement surgery
• History of frequent falls
• Admitted for syncope.
• If patients have specifically opted out of being contacted about research (visible in the Epic header while in their chart)
• Admitted from nursing home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FitBit Group; Will receive a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay. They will receive nudges twice/day to ambulate	Behavioral: Ambulation; This group will be encouraged twice daily to ambulate
Active Comparator: Control Group-Standard of Care; 300 subjects who will receive usual standard of care on a general inpatient medicine unit with the addition of a wearable device (FitBit) to track usual mobility in this setting. will complete their admission without push for increased activity (although having the device may influence their steps taken).	Other: Standard of Care; Care as usual at inpatient NYU Langone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine how many steps patients admitted to the medicine units are taking at baseline	Steps will be measured using a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay	1 Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Gavriil Ilizarov, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17-01792

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No