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/NCT06040658</url>
    </required_header>
    <id_info>
      <org_study_id>GN23CE014</org_study_id>
      <nct_id>NCT06040658</nct_id>
    </id_info>
    <brief_title>Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value</brief_title>
    <acronym>FAVOUR</acronym>
    <official_title>Frailty Assessment in Vascular OUtpatients Review (FAVOUR Trial) - Comparing Feasibility and Prognostic Value of Commonly Used Assessments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Glasgow</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>
        A single-centre prospective study of feasibility assessing the suitability of introducing&#xD;
        routine frailty screening in a controlled, and reproducible, outpatient department setting&#xD;
        for Vascular Surgery patients. This study will also perform head-to-head comparisons of the&#xD;
        prognostic value of five frailty assessment tools, selected based on the previous&#xD;
        demonstration of their popularity and familiarity within the speciality, their designs being&#xD;
        based on different theories of frailty and that some are endorsed by local healthcare police.&#xD;
        Inter-user variability (patient self assessment and clinician assessment will also be&#xD;
        compared).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This single-centre prospective cohort study of feasibility, is conducted in a rapid-referral&#xD;
        vascular surgery clinic, serving a population of 2 million. Capax adults (&gt;18years),&#xD;
        attending clinic for any reason are eligible for inclusion. Five frailty assessments are&#xD;
        completed at the clinic by patient (Rockwood Clinical Frailty Scale [CFS] and Frail&#xD;
        NonDisabled Questionnaire [FiND]), clinician (CFS, Health care Improvement Scotland FRAIL&#xD;
        Scale and 'Initial Clinical Evaluation') and researcher (11-item modified Frailty Index,&#xD;
        mFI-11). Consistent with feasibility objectives, outcome measures include recruitment rates,&#xD;
        frailty assessment completion rates, time-to-complete assessments and inter-rater&#xD;
        variability. Electronic follow-up at 30-days and 1-year will assess home-time and mortality&#xD;
        as prognostic indicators. Patients treated surgically/endovascularly will undergo additional&#xD;
        30-day and 1-year post-operative follow-up, outcome measures include: surgical procedure,&#xD;
        mortality, complications (according to Clavien-Dindo Classification), length-of-stay,&#xD;
        readmission rates, non-home discharge, home-time, higher social care requirements on&#xD;
        discharge and amputation-free survival. Prognostic value will be compared by area under&#xD;
        Receiver operator characteristic (ROC) curves. Continuous outcome variables will be analysed&#xD;
        using Spearman's rank correlation coefficient. Inter-user agreement will be compared by&#xD;
        percentage agreement in Cohen's Kappa coefficient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 15, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Actual">July 17, 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>Feasibility of implementing routine frailty assessment in a vascular clinic setting</measure>
      <time_frame>During participant recruitment, over up to 4 months.</time_frame>
      <description>Proportion of patients recruited (Number of recruited patients/[number of patients attending clinic - number of ineligible patients]).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frailty assessment completion time</measure>
      <time_frame>During participant recruitment, over up to 4 months.</time_frame>
      <description>Time taken to complete assessments (presented in seconds). The less time taken, the better.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Frailty assessment completion rates</measure>
      <time_frame>During participant recruitment, over up to 4 months.</time_frame>
      <description>Proportion of assessments with non-completion. Calculated by: number of incomplete frailty assessments/total number of recruited patients, the lower the value the better.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)</measure>
      <time_frame>30-days and 1 year from recruitment/clinic attendance</time_frame>
      <description>'Home time': this describes the number of full days at home (not as a hospital inpatient) over the follow up periods. All recruited patients will undergo this follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)</measure>
      <time_frame>30-days and 1 year from recruitment/clinic attendance</time_frame>
      <description>Mortality: this will be calculated from date of recruitment. All recruited patients will undergo this follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)</measure>
      <time_frame>30-days and 1 year from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: mortality. Proportion of patients dead at follow up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)</measure>
      <time_frame>30-days and 1 year from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: post-operative complications (according to the Clavien-Dindo Classification).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)</measure>
      <time_frame>30-days and 1 year from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: length of hospital stay (full days). Calculated as number of full days as inpatient following admission for index procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)</measure>
      <time_frame>30-days from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: readmission rates (to any speciality). This will be calculated by the proportion of patients readmitted to hospital following index procedure/the number of patients undergoing surgical/endovascular treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)</measure>
      <time_frame>30-days from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: non-home discharge. This will be calculated by the proportion of patients who are discharged to place of residence differing from their preoperative residence/total number of patients undergoing surgical/endovascular treatment. For example, from private residence preoperatively to care home.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)</measure>
      <time_frame>30-days and 1 year from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: home time. See outcome 4.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)</measure>
      <time_frame>30-days from primary intervention offered following recruitment to study.</time_frame>
      <description>For patients offered endovascular/surgical/hybrid intervention: discharge with a higher level of social care requirements. This will be presented as the proportion of patients discharged with greater social care requirements than before their index admission/'total number of patients offered surgical or endovascular treatment. E.g., a patient is admitted preopertively with three times daily package of care and discharged with four times daily package of care</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Frailty</condition>
    <condition>Frail Elderly Syndrome</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Vascular 'hot' clinic.</arm_group_label>
      <description>All adults (aged &gt; 17 years) referred to an urgent-referral, consultant-led, Vascular Surgery outpatient clinic, who have capacity, will be eligible for inclusion in this study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Frailty assessment</intervention_name>
      <description>Rockwood Clinical Frailty Scale</description>
      <arm_group_label>Vascular 'hot' clinic.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Frailty assessment</intervention_name>
      <description>Frail NonDisabled Questionnaire (FiND)</description>
      <arm_group_label>Vascular 'hot' clinic.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Frailty assessment</intervention_name>
      <description>Clinician's subjective 'end-of-bed' test</description>
      <arm_group_label>Vascular 'hot' clinic.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Frailty assessment</intervention_name>
      <description>Healthcare Improvement Scotland FRAIL Scale</description>
      <arm_group_label>Vascular 'hot' clinic.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Frailty assessment</intervention_name>
      <description>11-item modified Frailty Index (mFI-11)</description>
      <arm_group_label>Vascular 'hot' clinic.</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All referrals to vascular hot clinic are eligible for inclusion, preferentially recruiting&#xD;
          new referrals. As frailty is related to age, but does not directly correlate with it, no&#xD;
          age cut-off has been defined. As this is primarily a study of feasibility, patients will&#xD;
          not be excluded/included based on presenting symptom or diagnosed pathology.&#xD;
  &#xD;
          A proxy (relative/friend/carer), if present, will also be invited to participate and assist&#xD;
          with frailty assessments of the patients, where suitable. The participation of the proxy is&#xD;
          dependent on the patient providing written consent agreeing to their participation, as well&#xD;
          as the proxy being eligible to participate, according to the same inclusion/exclusion&#xD;
          criteria set out for patients below.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults (aged 18 years or older)&#xD;
  &#xD;
            -  Attending Vascular Hot Clinic&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lacking capacity to provide informed consent&#xD;
  &#xD;
            -  Parent clinical team feel frailty assessment not suitable&#xD;
  &#xD;
            -  Non-English speaker without qualified translator present&#xD;
  &#xD;
            -  Prisoners&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Quinn</last_name>
      <role>Study Director</role>
      <affiliation>University of Glasgow</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Welsh</last_name>
      <phone>07786123590</phone>
      <email>silje.welsh@glasgow.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Queen Elizabeth University Hospital</name>
        <address>
          <city>Glasgow</city>
          <state>Lanarkshire</state>
          <zip>G51 4TF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Welsh</last_name>
        <email>silje.welsh@glasgow.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Glasgow</investigator_affiliation>
      <investigator_full_name>Silje Welsh</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Pseudonymised research data will be uploaded to appropriate data registry</ipd_description>
    </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/NCT06040658
  org study id: GN23CE014
  nct id: NCT06040658
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A single-centre prospective study of feasibility assessing the suitability of introducing
        routine frailty screening in a controlled, and reproducible, outpatient department setting
        for Vascular Surgery patients. This study will also perform head-to-head comparisons of the
        prognostic value of five frailty assessment tools, selected based on the previous
        demonstration of their popularity and familiarity within the speciality, their designs being
        based on different theories of frailty and that some are endorsed by local healthcare police.
        Inter-user variability (patient self assessment and clinician assessment will also be
        compared).
  This single-centre prospective cohort study of feasibility, is conducted in a rapid-referral
        vascular surgery clinic, serving a population of 2 million. Capax adults (>18years),
        attending clinic for any reason are eligible for inclusion. Five frailty assessments are
        completed at the clinic by patient (Rockwood Clinical Frailty Scale [CFS] and Frail
        NonDisabled Questionnaire [FiND]), clinician (CFS, Health care Improvement Scotland FRAIL
        Scale and 'Initial Clinical Evaluation') and researcher (11-item modified Frailty Index,
        mFI-11). Consistent with feasibility objectives, outcome measures include recruitment rates,
        frailty assessment completion rates, time-to-complete assessments and inter-rater
        variability. Electronic follow-up at 30-days and 1-year will assess home-time and mortality
        as prognostic indicators. Patients treated surgically/endovascularly will undergo additional
        30-day and 1-year post-operative follow-up, outcome measures include: surgical procedure,
        mortality, complications (according to Clavien-Dindo Classification), length-of-stay,
        readmission rates, non-home discharge, home-time, higher social care requirements on
        discharge and amputation-free survival. Prognostic value will be compared by area under
        Receiver operator characteristic (ROC) curves. Continuous outcome variables will be analysed
        using Spearman's rank correlation coefficient. Inter-user agreement will be compared by
        percentage agreement in Cohen's Kappa coefficient.
  observational model: Cohort
  time perspective: Prospective
  measure: Feasibility of implementing routine frailty assessment in a vascular clinic setting
  time frame: During participant recruitment, over up to 4 months.
  description: Proportion of patients recruited (Number of recruited patients/[number of patients attending clinic - number of ineligible patients]).
  measure: Frailty assessment completion time
  time frame: During participant recruitment, over up to 4 months.
  description: Time taken to complete assessments (presented in seconds). The less time taken, the better.
  measure: Frailty assessment completion rates
  time frame: During participant recruitment, over up to 4 months.
  description: Proportion of assessments with non-completion. Calculated by: number of incomplete frailty assessments/total number of recruited patients, the lower the value the better.
  measure: Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)
  time frame: 30-days and 1 year from recruitment/clinic attendance
  description: 'Home time': this describes the number of full days at home (not as a hospital inpatient) over the follow up periods. All recruited patients will undergo this follow-up.
  measure: Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)
  time frame: 30-days and 1 year from recruitment/clinic attendance
  description: Mortality: this will be calculated from date of recruitment. All recruited patients will undergo this follow-up.
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)
  time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: mortality. Proportion of patients dead at follow up.
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)
  time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: post-operative complications (according to the Clavien-Dindo Classification).
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)
  time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: length of hospital stay (full days). Calculated as number of full days as inpatient following admission for index procedure.
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)
  time frame: 30-days from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: readmission rates (to any speciality). This will be calculated by the proportion of patients readmitted to hospital following index procedure/the number of patients undergoing surgical/endovascular treatment.
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)
  time frame: 30-days from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: non-home discharge. This will be calculated by the proportion of patients who are discharged to place of residence differing from their preoperative residence/total number of patients undergoing surgical/endovascular treatment. For example, from private residence preoperatively to care home.
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)
  time frame: 30-days and 1 year from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: home time. See outcome 4.
  measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)
  time frame: 30-days from primary intervention offered following recruitment to study.
  description: For patients offered endovascular/surgical/hybrid intervention: discharge with a higher level of social care requirements. This will be presented as the proportion of patients discharged with greater social care requirements than before their index admission/'total number of patients offered surgical or endovascular treatment. E.g., a patient is admitted preopertively with three times daily package of care and discharged with four times daily package of care
  arm group label: Vascular 'hot' clinic.
  description: All adults (aged > 17 years) referred to an urgent-referral, consultant-led, Vascular Surgery outpatient clinic, who have capacity, will be eligible for inclusion in this study.
  intervention type: Diagnostic Test
  intervention name: Frailty assessment
  description: Rockwood Clinical Frailty Scale
  arm group label: Vascular 'hot' clinic.
  intervention type: Diagnostic Test
  intervention name: Frailty assessment
  description: Frail NonDisabled Questionnaire (FiND)
  arm group label: Vascular 'hot' clinic.
  intervention type: Diagnostic Test
  intervention name: Frailty assessment
  description: Clinician's subjective 'end-of-bed' test
  arm group label: Vascular 'hot' clinic.
  intervention type: Diagnostic Test
  intervention name: Frailty assessment
  description: Healthcare Improvement Scotland FRAIL Scale
  arm group label: Vascular 'hot' clinic.
  intervention type: Diagnostic Test
  intervention name: Frailty assessment
  description: 11-item modified Frailty Index (mFI-11)
  arm group label: Vascular 'hot' clinic.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Quinn
  role: Study Director
  affiliation: University of Glasgow
  last name: Welsh
  phone: 07786123590
  email: silje.welsh@glasgow.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Glasgow
  investigator full name: Silje Welsh
  investigator title: Principle Investigator
  mesh term: Frailty
  sharing ipd: Undecided
  ipd description: Pseudonymised research data will be uploaded to appropriate data registry