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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04444453
Other study ID # IRB202001410
Secondary ID IRB202001410
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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