NCT04444453

Brief Summary

Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also reduced adverse events such as venous thromboembolism (VTE). We will test if a patient wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation, decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable pedometer or usual care. Patients randomized to the study intervention will receive a wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study outcome measures to be compared between the pedometer and no pedometer group include hospital LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence of VTEs, patient experience, and costs (secondary outcomes).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

June 18, 2020

Last Update Submit

January 13, 2023

Conditions

Keywords

length of stayhospitalization

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    Time patient is admitted in hospital

    Up to 1 month

Secondary Outcomes (5)

  • Hospital length-of-stay index

    Up to 1 month

  • Time to first ambulation

    Up to 1 month

  • Time to first bowel movement

    Up to 1 month

  • Rate of venous thromboembolism

    Up to 1 month

  • Total hospitalization costs

    Up to 1 month

Study Arms (2)

Pedometer

EXPERIMENTAL

Admitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated

Device: Wearable Pedometer

Control

NO INTERVENTION

Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care

Interventions

Pedometer worn on wrist

Also known as: Pedometer
Pedometer

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ages \> or equal to 18 years
  • Patient has capacity to undergo informed consent
  • Admitted to UF Health Jacksonville 8N progressive inpatient unit
  • Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission
  • Patient with a Fall Predictive Analytics score category of "low risk"
  • Patient with a Morse Fall Scale (MFS) of \< or equal to 50
  • No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)

You may not qualify if:

  • Patient \< 18 years of age
  • Patient without capacity to undergo informed consent
  • Patient with a 'do not ambulate' order or has order for bed rest or other contraindication to ambulation (i.e., fall risk) or dependent on more than minimal assistance to ambulate
  • Patient with a Fall Predictive Analytics score category of "high risk"
  • Patient with MFS \> 50 or labelled by clinical team as fall risk
  • Non-English speaking
  • In law enforcement custody or ward of the state
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Study Officials

  • Jennifer Fishe, MD

    University of Florida

    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

June 18, 2020

First Posted

June 23, 2020

Study Start

October 21, 2020

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations