<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/NCT03814161</url>
  </required_header>
  <id_info>
    <org_study_id>FREEDOM</org_study_id>
    <nct_id>NCT03814161</nct_id>
  </id_info>
  <brief_title>FRailty Among Elderly Emergency Department Patients With Outcome Measures</brief_title>
  <acronym>FREEDOM</acronym>
  <official_title>FRailty Among Elderly Emergency Department Patients With Outcome Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS),&#xD;
      Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F),&#xD;
      which can potentially be adopted for daily practice in the busy ED. It is timely as we&#xD;
      projected that we will be seeing more elderly patients attending the ED for various medical&#xD;
      and surgical conditions. Their attendance at the ED would be a good opportunity to screen for&#xD;
      frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or&#xD;
      subsequent hospitalisation that might lead to poor functional outcomes and higher dependence&#xD;
      on step-down care facilities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>1-month Adverse Event Occurrence (composite)</measure>
    <time_frame>At 1 month after index ED visit</time_frame>
    <description>Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3-month Adverse Event Occurrence (composite)</measure>
    <time_frame>At 3 months after index ED visit</time_frame>
    <description>Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality</description>
  </secondary_outcome>
  <enrollment type="Actual">211</enrollment>
  <condition>Geriatric, Frailty, Emergency Department</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly patients aged 65 years and above attending Emergency Department, National&#xD;
        University Hospital, Singapore irrespective of reason for attendance and are planned for&#xD;
        discharge from the Emergency Department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Elderly patients aged 65 years and above attending ED irrespective of reason for&#xD;
        attendance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Haemodynamically unstable patients&#xD;
&#xD;
          -  Inability to obtain informed consent&#xD;
&#xD;
          -  Inability to obtain reliable information from patient or caregiver (e.g. deafness,&#xD;
             blindness, language barriers)&#xD;
&#xD;
          -  Vulnerable populations (e.g. prisoners)&#xD;
&#xD;
          -  Patients who are planned for hospital admission from the ED&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying Wei Yau</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University Hospital, Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>119085</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.</citation>
    <PMID>23764209</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <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/NCT03814161
org study id: FREEDOM
nct id: NCT03814161
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS),
      Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F),
      which can potentially be adopted for daily practice in the busy ED. It is timely as we
      projected that we will be seeing more elderly patients attending the ED for various medical
      and surgical conditions. Their attendance at the ED would be a good opportunity to screen for
      frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or
      subsequent hospitalisation that might lead to poor functional outcomes and higher dependence
      on step-down care facilities.
observational model: Cohort
time perspective: Prospective
measure: 1-month Adverse Event Occurrence (composite)
time frame: At 1 month after index ED visit
description: Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality
measure: 3-month Adverse Event Occurrence (composite)
time frame: At 3 months after index ED visit
description: Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Ying Wei Yau
role: Principal Investigator
affiliation: National University Hospital, Singapore
facility: 
country: Singapore
citation: Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
PMID: 23764209
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Frailty
sharing ipd: No