<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04444453</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202001410</org_study_id>
    <secondary_id>IRB202001410</secondary_id>
    <nct_id>NCT04444453</nct_id>
  </id_info>
  <brief_title>Early Ambulation to Reduce Hospital Length of Stay</brief_title>
  <acronym>EARLY</acronym>
  <official_title>Early Ambulation to Reduce Hospital Length of Stay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also&#xD;
      reduced adverse events such as venous thromboembolism (VTE). We will test if a patient&#xD;
      wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS&#xD;
      (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation,&#xD;
      decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs&#xD;
      (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult&#xD;
      patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable&#xD;
      pedometer or usual care. Patients randomized to the study intervention will receive a&#xD;
      wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study&#xD;
      outcome measures to be compared between the pedometer and no pedometer group include hospital&#xD;
      LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence&#xD;
      of VTEs, patient experience, and costs (secondary outcomes).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Actual">September 1, 2022</completion_date>
  <primary_completion_date type="Actual">August 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>Time patient is admitted in hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length-of-stay index</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first ambulation</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first bowel movement</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of venous thromboembolism</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospitalization costs</measure>
    <time_frame>Up to 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Ambulation</condition>
  <condition>Wearable Devices</condition>
  <arm_group>
    <arm_group_label>Pedometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Admitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wearable Pedometer</intervention_name>
    <description>Pedometer worn on wrist</description>
    <arm_group_label>Pedometer</arm_group_label>
    <other_name>Pedometer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients ages &gt; or equal to 18 years&#xD;
&#xD;
          2. Patient has capacity to undergo informed consent&#xD;
&#xD;
          3. Admitted to UF Health Jacksonville 8N progressive inpatient unit&#xD;
&#xD;
          4. Inpatient physician orders for patient ambulation and/or activity as tolerated upon&#xD;
             hospital admission&#xD;
&#xD;
          5. Patient with a Fall Predictive Analytics score category of &quot;low risk&quot;&#xD;
&#xD;
          6. Patient with a Morse Fall Scale (MFS) of &lt; or equal to 50&#xD;
&#xD;
          7. No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin&#xD;
             infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist&#xD;
             site)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient &lt; 18 years of age&#xD;
&#xD;
          2. Patient without capacity to undergo informed consent&#xD;
&#xD;
          3. Patient with a 'do not ambulate' order or has order for bed rest or other&#xD;
             contraindication to ambulation (i.e., fall risk) or dependent on more than minimal&#xD;
             assistance to ambulate&#xD;
&#xD;
          4. Patient with a Fall Predictive Analytics score category of &quot;high risk&quot;&#xD;
&#xD;
          5. Patient with MFS &gt; 50 or labelled by clinical team as fall risk&#xD;
&#xD;
          6. Non-English speaking&#xD;
&#xD;
          7. In law enforcement custody or ward of the state&#xD;
&#xD;
          8. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Fishe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>length of stay</keyword>
  <keyword>hospitalization</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444453
org study id: IRB202001410
secondary id: IRB202001410
nct id: NCT04444453
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Hospital Length of Stay
time frame: Up to 1 month
description: Time patient is admitted in hospital
measure: Hospital length-of-stay index
time frame: Up to 1 month
measure: Time to first ambulation
time frame: Up to 1 month
measure: Time to first bowel movement
time frame: Up to 1 month
measure: Rate of venous thromboembolism
time frame: Up to 1 month
measure: Total hospitalization costs
time frame: Up to 1 month
arm group label: Pedometer
arm group type: Experimental
description: Admitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated
arm group label: Control
arm group type: No Intervention
description: Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care
intervention type: Device
intervention name: Wearable Pedometer
description: Pedometer worn on wrist
arm group label: Pedometer
other name: Pedometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jennifer Fishe, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No