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

NCT ID: NCT03595605

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-16
• Study Completion Date: 2019-03-30

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.

Conditions

Physical Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ambulation

Intervention Type: BEHAVIORAL

This group will be encouraged twice daily to ambulate

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Care as usual at inpatient NYU Langone

Interventions

Ambulation

This group will be encouraged twice daily to ambulate

Intervention Type: BEHAVIORAL

Standard of Care

Care as usual at inpatient NYU Langone

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 66 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gavriil Ilizarov

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01792

Identifier Type: -

Identifier Source: org_study_id