<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/NCT04431986</url>
  </required_header>
  <id_info>
    <org_study_id>2021-2432</org_study_id>
    <nct_id>NCT04431986</nct_id>
  </id_info>
  <brief_title>ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers</brief_title>
  <official_title>Association Between Emergency Room Evaluation and Recommendations Tool (ER2) Frailty Levels and Incident Adverse Health Events in Older Community Dwellers: Results of the NuAge Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jewish General Hospital</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>
      Older adults' health and functional status are heterogeneous because of the various&#xD;
      cumulative effects of chronic diseases and physiologic decline, contributing to a vicious&#xD;
      cycle of increased frailty 1-4. Thanks to advances in medicine and hygiene, a growing number&#xD;
      of older adults spend more years with a greater range of chronic diseases causing disability&#xD;
      but not mortality 5. Health systems need to face this new challenge 4,5. Quantification of&#xD;
      frailty and its association with the occurrence of incident adverse health events (i.e.,&#xD;
      functional decline, unplanned hospitalizations) is crucial to understand how health systems&#xD;
      may efficiently respond to this situation 6. This study aims to examine the association of&#xD;
      the ER2 tool score and its stratification in three levels for incident adverse health events&#xD;
      in older community dwellers and to compare this association with three validity frailty&#xD;
      indexes which are the Cardiovascular Health Study (CHS) frailty index, Study of Osteoporotic&#xD;
      Fracture (SOF) index and Rockwood frailty index.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</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>ER2</measure>
    <time_frame>4 years</time_frame>
    <description>6-item questionnaire determining a stratification of frailty risk in three levels (Low, moderate, high)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SOF index</measure>
    <time_frame>4 years</time_frame>
    <description>index with 3 items determining a level of frailty from 0 (patient is vigorous) to 1 (patient is pre-frail)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CHS index</measure>
    <time_frame>4 years</time_frame>
    <description>index with 5 items determining a level of frailty from 0 component positive (patient is vigorous), 1 or 2 positive components (patient is in an intermediate stage) to 3 or more positive components (patients is frail)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rockwood index</measure>
    <time_frame>4 years</time_frame>
    <description>index determining a level of frailty from 0 to 17 (less than 5: patient is vigorous, between 6 and 11 patient is apparently vulnerable and above 12 patient is in severe frailty)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical functional decline</measure>
    <time_frame>4 years</time_frame>
    <description>annual variation of physical functional score available in the Nuage database</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Falls</measure>
    <time_frame>4 years</time_frame>
    <description>presence or absence of falls, information available in the Nuage database</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>4 years</time_frame>
    <description>presence or absence of hospitalizations, information available in the Nuage database</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>4 years</time_frame>
    <description>death of the participant, information available in the Nuage database</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1741</enrollment>
  <condition>Frailty</condition>
  <condition>Emergencies</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>NuAge participants</arm_group_label>
    <description>All Individuals of the NuAge study who agreed to be part of the NuAge Database for future research purposes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention: secondary use of a database</intervention_name>
    <description>Statistical analyses</description>
    <arm_group_label>NuAge participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals eligible for this study will be participants of the NuAge study who agreed to&#xD;
        be part of the NuAge Database and Biobank for future research purposes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All enrolled participants of NuAge Study who agreed to be part of the NuAge Database&#xD;
             and Biobank for future research purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing data&#xD;
&#xD;
          -  Participants' refusal to use their data for a purpose not identified during their&#xD;
             recruitment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cyrille Launay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jewish General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cyrille Launay, MD</last_name>
    <phone>(+1) 514 340-8222</phone>
    <phone_ext>23837</phone_ext>
    <email>cyrille.launay@mcgill.ca</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Cyrille Launay</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
    <ipd_description>The databank property is not ours. We do not have the right to share IPD.</ipd_description>
  </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/NCT04431986
org study id: 2021-2432
nct id: NCT04431986
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Older adults' health and functional status are heterogeneous because of the various
      cumulative effects of chronic diseases and physiologic decline, contributing to a vicious
      cycle of increased frailty 1-4. Thanks to advances in medicine and hygiene, a growing number
      of older adults spend more years with a greater range of chronic diseases causing disability
      but not mortality 5. Health systems need to face this new challenge 4,5. Quantification of
      frailty and its association with the occurrence of incident adverse health events (i.e.,
      functional decline, unplanned hospitalizations) is crucial to understand how health systems
      may efficiently respond to this situation 6. This study aims to examine the association of
      the ER2 tool score and its stratification in three levels for incident adverse health events
      in older community dwellers and to compare this association with three validity frailty
      indexes which are the Cardiovascular Health Study (CHS) frailty index, Study of Osteoporotic
      Fracture (SOF) index and Rockwood frailty index.
observational model: Cohort
time perspective: Prospective
measure: ER2
time frame: 4 years
description: 6-item questionnaire determining a stratification of frailty risk in three levels (Low, moderate, high)
measure: SOF index
time frame: 4 years
description: index with 3 items determining a level of frailty from 0 (patient is vigorous) to 1 (patient is pre-frail)
measure: CHS index
time frame: 4 years
description: index with 5 items determining a level of frailty from 0 component positive (patient is vigorous), 1 or 2 positive components (patient is in an intermediate stage) to 3 or more positive components (patients is frail)
measure: Rockwood index
time frame: 4 years
description: index determining a level of frailty from 0 to 17 (less than 5: patient is vigorous, between 6 and 11 patient is apparently vulnerable and above 12 patient is in severe frailty)
measure: Physical functional decline
time frame: 4 years
description: annual variation of physical functional score available in the Nuage database
measure: Falls
time frame: 4 years
description: presence or absence of falls, information available in the Nuage database
measure: Hospitalizations
time frame: 4 years
description: presence or absence of hospitalizations, information available in the Nuage database
measure: Mortality
time frame: 4 years
description: death of the participant, information available in the Nuage database
arm group label: NuAge participants
description: All Individuals of the NuAge study who agreed to be part of the NuAge Database for future research purposes
intervention type: Other
intervention name: No intervention: secondary use of a database
description: Statistical analyses
arm group label: NuAge participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cyrille Launay, MD
role: Principal Investigator
affiliation: Jewish General Hospital
last name: Cyrille Launay, MD
phone: (+1) 514 340-8222
phone ext: 23837
email: cyrille.launay@mcgill.ca
responsible party type: Principal Investigator
investigator affiliation: Jewish General Hospital
investigator full name: Cyrille Launay
investigator title: Principal Investigator
mesh term: Emergencies
mesh term: Frailty
sharing ipd: No
ipd description: The databank property is not ours. We do not have the right to share IPD.