xml: <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/NCT06012942</url>
    </required_header>
    <id_info>
      <org_study_id>HNF1632-22</org_study_id>
      <nct_id>NCT06012942</nct_id>
    </id_info>
    <brief_title>Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients</brief_title>
    <acronym>SkrInt</acronym>
    <official_title>Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital of North Norway</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Royal Norwegian Ministry of Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Haukeland University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital, Akershus</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Trondheim University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bodø Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital of North Norway</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>
        The primary aim is to study change of critical frailty scale (CFS) and health related quality&#xD;
        of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important&#xD;
        ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr).&#xD;
  &#xD;
        Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment&#xD;
        intensity level, severity score and mortality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-centre norwegian observational, prospective multicenter Norway coordinated&#xD;
        from University hospital North Norway, Tromso.&#xD;
  &#xD;
        The study is approved by The Regional Committee for Medical Research Ethics Northern Norway.&#xD;
  &#xD;
        The following scores will be assessed by asking the patient and relative during ICU stay:&#xD;
        CFS, EQ5DL before current critical illness.&#xD;
  &#xD;
        The following demographic and clinical data will be retrieved from the medical records:&#xD;
        Comorbidity before critical illness, reasons for ICU admission, daily severity score (SOFA-&#xD;
        score), length of mechanical ventilation, dialysis, tracheostomy, Habitat before and after&#xD;
        ICU treatment, ICU and hospital length of stay, complications retrieved during intensive care&#xD;
        treatment, mortality, limitation of treatment.&#xD;
  &#xD;
        The patients will be followed up with telephone interview after hospital discharge for&#xD;
        evaluation of: Comorbidity, CFS, EQ5DData for all sites are collected and managed using&#xD;
        RedCap electronic data capture tools.&#xD;
  &#xD;
        Three research nurses will do the follow up with telephone interviews on all sites and record&#xD;
        the data in RedCap.&#xD;
  &#xD;
        We aim to enroll 300 patients before 31. Des 2024.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Change in Clinical frailty score</measure>
      <time_frame>Change in Clinical Frailty score from 3 months to 12 months follow up</time_frame>
      <description>Score from 1 to 9.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EuroQol 5-Dimension 5-Level (EQ-5D-5L)</measure>
      <time_frame>Change in EQ-5D-5L from 3 months to 12 months</time_frame>
      <description>The scale measures quality of life on a 5-component scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>ICU-stay or subsequent 12 months.</time_frame>
      <description>Mortality during ICU-stay or subsequent 12 months.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ICU readmission</measure>
      <time_frame>Long-term follow up (1 yr)</time_frame>
      <description>ICU readmission rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU-LOS</measure>
      <time_frame>Through total ICU stay, up to 3 months</time_frame>
      <description>ICU length of stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment intensity level</measure>
      <time_frame>From inclusion in the study to discharge from intensive care unit, up to three months.</time_frame>
      <description>ICU treatment intensity level</description>
    </secondary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Frailty</condition>
    <condition>Critical Illness</condition>
    <eligibility>
      <study_pop>
        <textblock>
          ICU patients above 65 years old requiring invasive mechanical ventilation&gt; 24 hours are&#xD;
          screened for inclusion during the intensive care stay.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;= 65 years&#xD;
  &#xD;
            -  ≥ 24 hours mechanical ventilation&#xD;
  &#xD;
            -  Written informed consent from patient or next of kin&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Readmission of patient included in the study&#xD;
  &#xD;
            -  Not possible to obtain a valid CFS or and EQ-5D-5L at admission or follow-up of CFS&#xD;
               because of social context or language.&#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>Shirin K Frisvold, MD/PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of North Norway</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Bjørn A Kroken, MD</last_name>
      <phone>77669863</phone>
      <phone_ext>+47</phone_ext>
      <email>bjorn.anders.kroken@unn.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shirin K Frisvold, MD/PhD</last_name>
      <phone>77669605</phone>
      <phone_ext>+47</phone_ext>
      <email>shirin.kordasti@unn.no</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Akershus University hospital, General Intensive care department</name>
        <address>
          <city>Lørenskog</city>
          <state>Nordbyhagen</state>
          <zip>1478</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ole Kristian Fossum, MD/PhD</last_name>
        <email>Ole.Kristian.Fossum@ahus.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Haukeland University hospital, General Intensive care unit</name>
        <address>
          <city>Bergen</city>
          <zip>5021</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Reidar Kvåle, MD7PhD</last_name>
        <email>reidar.kvale@helse-bergen.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nordlandssykehuset Bodø, Intensivavdelingen</name>
        <address>
          <city>Bodø</city>
          <zip>8005</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristin S Berg, MD/PhD</last_name>
        <email>kristin.berg2@nordlandssykehuset.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Hospital of North Norway</name>
        <address>
          <city>Tromsø</city>
          <zip>9038</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bjørn A Kroken, MD</last_name>
        <phone>97514485</phone>
        <phone_ext>+47</phone_ext>
        <email>bjorn.anders.kroken@unn.no</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Trondheim University hospital, General Intensive care department</name>
        <address>
          <city>Trondheim</city>
          <zip>7006</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Bergum, MD/PhD</last_name>
        <email>Daniel.Bergum@stolav.no</email>
      </contact>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <reference>
      <citation>Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (&gt;/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.</citation>
      <PMID>28936626</PMID>
    </reference>
    <reference>
      <citation>Flaatten H, Beil M, Guidet B. Prognostication in older ICU patients: mission impossible? Br J Anaesth. 2020 Nov;125(5):655-657. doi: 10.1016/j.bja.2020.08.005. Epub 2020 Aug 14. No abstract available.</citation>
      <PMID>32868042</PMID>
    </reference>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>February 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>clinical frailty scale</keyword>
    <keyword>mechanical ventilation</keyword>
    <keyword>elderly</keyword>
    <keyword>EQ-5D-5L</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 12 months and ending 5 years following article publication.</ipd_time_frame>
      <ipd_access_criteria>The presented dataset will be considered available from the corresponding author on reasonable request based on formal national approvals.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012942
  org study id: HNF1632-22
  nct id: NCT06012942
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary aim is to study change of critical frailty scale (CFS) and health related quality
        of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important
        ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr).
  
        Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment
        intensity level, severity score and mortality.
  This is a multi-centre norwegian observational, prospective multicenter Norway coordinated
        from University hospital North Norway, Tromso.
  
        The study is approved by The Regional Committee for Medical Research Ethics Northern Norway.
  
        The following scores will be assessed by asking the patient and relative during ICU stay:
        CFS, EQ5DL before current critical illness.
  
        The following demographic and clinical data will be retrieved from the medical records:
        Comorbidity before critical illness, reasons for ICU admission, daily severity score (SOFA-
        score), length of mechanical ventilation, dialysis, tracheostomy, Habitat before and after
        ICU treatment, ICU and hospital length of stay, complications retrieved during intensive care
        treatment, mortality, limitation of treatment.
  
        The patients will be followed up with telephone interview after hospital discharge for
        evaluation of: Comorbidity, CFS, EQ5DData for all sites are collected and managed using
        RedCap electronic data capture tools.
  
        Three research nurses will do the follow up with telephone interviews on all sites and record
        the data in RedCap.
  
        We aim to enroll 300 patients before 31. Des 2024.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in Clinical frailty score
  time frame: Change in Clinical Frailty score from 3 months to 12 months follow up
  description: Score from 1 to 9.
  measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
  time frame: Change in EQ-5D-5L from 3 months to 12 months
  description: The scale measures quality of life on a 5-component scale
  measure: Mortality
  time frame: ICU-stay or subsequent 12 months.
  description: Mortality during ICU-stay or subsequent 12 months.
  measure: ICU readmission
  time frame: Long-term follow up (1 yr)
  description: ICU readmission rate
  measure: ICU-LOS
  time frame: Through total ICU stay, up to 3 months
  description: ICU length of stay
  measure: Treatment intensity level
  time frame: From inclusion in the study to discharge from intensive care unit, up to three months.
  description: ICU treatment intensity level
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shirin K Frisvold, MD/PhD
  role: Principal Investigator
  affiliation: University Hospital of North Norway
  last name: Bjørn A Kroken, MD
  phone: 77669863
  phone ext: +47
  email: bjorn.anders.kroken@unn.no
  last name: Shirin K Frisvold, MD/PhD
  phone: 77669605
  phone ext: +47
  email: shirin.kordasti@unn.no
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Norway
  citation: Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
  PMID: 28936626
  citation: Flaatten H, Beil M, Guidet B. Prognostication in older ICU patients: mission impossible? Br J Anaesth. 2020 Nov;125(5):655-657. doi: 10.1016/j.bja.2020.08.005. Epub 2020 Aug 14. No abstract available.
  PMID: 32868042
  responsible party type: Sponsor
  mesh term: Frailty
  mesh term: Critical Illness
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices).
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 12 months and ending 5 years following article publication.
  ipd access criteria: The presented dataset will be considered available from the corresponding author on reasonable request based on formal national approvals.