Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
1 other identifier
interventional
51
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedMay 29, 2020
May 1, 2020
11 months
May 22, 2018
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
EXPERIMENTALWill 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
Control Group-Standard of Care
ACTIVE COMPARATOR300 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).
Interventions
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gavriil Ilizarov
NYU Langone Health
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