Early Ambulation to Reduce Hospital Length of Stay

Wearable Devices Clinical Trial

— EARLY  

Official title:

Early Ambulation to Reduce Hospital Length of Stay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444453
• Other study ID #: IRB202001410
• Secondary ID: IRB202001410
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Patients ages > or equal to 18 years

2. Patient has capacity to undergo informed consent

3. Admitted to UF Health Jacksonville 8N progressive inpatient unit

4. Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission

5. Patient with a Fall Predictive Analytics score category of "low risk"

6. Patient with a Morse Fall Scale (MFS) of < or equal to 50

7. No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)

Exclusion Criteria:

1. Patient < 18 years of age

2. Patient without capacity to undergo informed consent

3. 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

4. Patient with a Fall Predictive Analytics score category of "high risk"

5. Patient with MFS > 50 or labelled by clinical team as fall risk

6. Non-English speaking

7. In law enforcement custody or ward of the state

8. Pregnancy

Related Conditions & MeSH terms

• Ambulation
• Wearable Devices

Intervention

Device:
• Wearable Pedometer
Pedometer worn on wrist

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Time patient is admitted in hospital	Up to 1 month
Secondary	Hospital length-of-stay index		Up to 1 month
Secondary	Time to first ambulation		Up to 1 month
Secondary	Time to first bowel movement		Up to 1 month
Secondary	Rate of venous thromboembolism		Up to 1 month
Secondary	Total hospitalization costs		Up to 1 month