NCT03595605

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 22, 2018

Last Update Submit

May 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

FitBit Group

EXPERIMENTAL

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

Control Group-Standard of Care

ACTIVE COMPARATOR

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

Interventions

AmbulationBEHAVIORAL

This group will be encouraged twice daily to ambulate

FitBit Group

Care as usual at inpatient NYU Langone

Control Group-Standard of Care

Eligibility Criteria

Age66 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

WalkingStandard of Care

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Gavriil Ilizarov

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

July 23, 2018

Study Start

May 16, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations