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/NCT06030765</url>
    </required_header>
    <id_info>
      <org_study_id>22-5810</org_study_id>
      <nct_id>NCT06030765</nct_id>
    </id_info>
    <brief_title>Detect CI (Cognitive Impairment) Study</brief_title>
    <acronym>CI</acronym>
    <official_title>Evaluation of Rapid Cognitive Screening Tools for Detection of Cognitive Impairment in Older Surgical Patients: A Prospective Cohort Study - Detect CI Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Health Network, Toronto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Health Network, Toronto</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective multicenter cohort study which will evaluate rapid (administration time&#xD;
        ≤ 5 minutes) cognitive screening tools that can be administered preoperatively in older&#xD;
        patients undergoing noncardiac surgery. Namely, our study will determine the diagnostic&#xD;
        accuracy (sensitivity, specificity, and area under the curves [AUC]) of two rapid, easily&#xD;
        administered cognitive screening tools: the Mini-Cog and the Ascertain Dementia 8-item&#xD;
        Questionnaire (AD8) against the Montreal Cognitive Assessment (MoCA). Additionally, we will&#xD;
        examine the prevalence of cognitive impairment (CI) in patients meeting the CI criteria by&#xD;
        either the AD8, Mini-Cog, or MoCA and the prevalence of elevated levels of plasma biomarker&#xD;
        of phosphorylated tau 181 (pTau181) and neurofilament-light chain (NfL) in the patients&#xD;
        meeting the CI criteria. This study will target older patients from surgical offices and/or&#xD;
        pre-admission clinics at Toronto General (TGH), Toronto Western (TWH), and Mount Sinai&#xD;
        Hospital (MSH), Toronto, Ontario. The identification and recruitment of eligible patients&#xD;
        will be a collaborative effort between the nurses, surgeons, anesthesiologists, and the&#xD;
        research team. Written informed consent to participate in the study will be obtained from all&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aims of the study is to (1) determine the diagnostic accuracy (sensitivity,&#xD;
        specificity, and the AUC) of two rapid cognitive screening tools (AD8 and Mini-Cog) against&#xD;
        the MoCA in the older surgical population and (2) determine the prevalence of CI as detected&#xD;
        by the cognitive screening tests (AD8, Mini-Cog, or MoCA) and to determine the prevalence of&#xD;
        elevated plasma biomarkers associated with neurodegenerative and/or vascular diseases using&#xD;
        plasma (pTau181 or NfL) biomarkers in those with CI as detected by the screening tools. The&#xD;
        secondary aims are to (1) describe the distribution of plasma pTau181 or NfL biomarkers in&#xD;
        patients meeting the CI criteria by the AD8, Mini-Cog, or MoCA, (2) compare the trajectory of&#xD;
        patient-reported outcomes at baseline, 30-, and 90-day post-surgery in patients with or&#xD;
        without CI as detected by the cognitive screening tests, and (3) compare clinical outcomes in&#xD;
        patients with or without CI as detected by the cognitive screening tests.&#xD;
  &#xD;
        The study consists of four consecutive time points, including one preoperative assessment and&#xD;
        three postoperative assessments occurring during participants' hospital stay and at 30- and&#xD;
        90-day post-surgery. In the preoperative assessment 1-30 days before their scheduled surgery,&#xD;
        patients will be asked to complete the AD8, Mini-Cog, MoCA and the STOP-Bang Questionnaire&#xD;
        in-person. If a patient screens positive on one or more of the three cognitive screening&#xD;
        tools, they will have blood drawn for pTau181 and NfL bioassay analysis. Additionally,&#xD;
        patients will be asked to complete the following assessments via an online survey or over the&#xD;
        telephone prior to their scheduled surgery: WHODAS-2.0 (World Health Organization Disability&#xD;
        Assessment Schedule 2.0), 5-item FRAIL Questionnaire, PHQ-4 (4-Item Patient Health&#xD;
        Questionnaire for Anxiety and depression), VAS (visual analog scale) pain, SQS (Single Item&#xD;
        Sleep Quality Scale), and a single question on QoL (quality of life).&#xD;
  &#xD;
        The first postoperative time point will occur during participants' stay at the hospital in&#xD;
        which postoperative delirium (POD), postoperative complications, length of stay (LOS), and&#xD;
        discharge destination will be assessed. At 30- and 90-day postoperatively, chart review will&#xD;
        be performed to assess clinical outcomes, such as postoperative complications, all-cause&#xD;
        mortality, and hospital readmission. Patient-reported outcomes, including WHODAS 2.0, 5-item&#xD;
        FRAIL Questionnaire, PHQ-4, VAS pain, and QoL, will also be assessed through an online survey&#xD;
        or over the telephone.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</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>The diagnostic accuracy (sensitivity, specificity, and AUC)</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The diagnostic accuracy (sensitivity and specificity) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The diagnostic accuracy (sensitivity, specificity, and AUC)</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The AUC (Area under the Receiver Operating Characteristic Curve (ROC)) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of cognitive impairment (CI) via cognitive screening tools</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The prevalence of CI as detected by the AD8 (Eight-item Interview to Differentiate Aging and Dementia). The AD8 is scored from 0-8 with a score of two or more indicating cognitive impairment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of cognitive impairment (CI) via cognitive screening tools</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The prevalence of CI as detected by the Mini-Cog. The Mini-Cog is scored from 0-5 with a score of two or less indicating cognitive impairment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of cognitive impairment (CI) via cognitive screening tools</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The prevalence of CI as detected by the MoCA (Montreal Cognitive Assessment). The MoCA is scored from 0-30 with a score of 25 or less indicating cognitive impairment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of elevated plasma biomarkers</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma pTau181 biomarkers in those with CI as detected by the screening tools.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of elevated plasma biomarkers</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma NfL biomarkers in those with CI as detected by the screening tools.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Distribution of plasma biomarkers</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The distribution of plasma pTau181 biomarkers in patients meeting the CI criteria by the cognitive screening tools.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distribution of plasma biomarkers</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The distribution of plasma NfL biomarkers in patients meeting the CI criteria by the cognitive screening tools.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery, 30- and 90-days post-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of functional disability as measured through the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) in participants with CI vs those without. A five-point rating scale is used for each question (none = 0, mild = 1, moderate = 2, severe = 3, extreme/cannot do = 4), and a higher WHODAS score indicates greater disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery, 30- and 90-days post-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of frailty as measured through the 5-item FRAIL questionnaire in participants with CI vs those without. It is scored from 0-5 where higher scores indicate frailty.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery, 30- and 90-days post-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of pain as measured through the VAS Pain (Visual Analog Scale for Pain) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates worse pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery, 30- and 90-days post-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of depression and anxiety as measured through the PHQ-4 (4-Item Patient Health Questionnaire) in participants with CI vs those without. It is scored from 0-12 where a higher score indicates depression and anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of obstructive sleep apnea (OSA) as measured through the STOP-Bang Questionnaire in participants with CI vs those without. It is scored from 0-8 where a higher score indicates higher risk for OSA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of sleep disturbances as measured through the SQS (Single Item Sleep Quality Scale) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates sleep disturbances.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery</measure>
      <time_frame>Pre-surgery, 30- and 90-days post-surgery</time_frame>
      <description>The trajectory and prevalence or incidence of quality of life as measured through the single question on Quality of Life (QoL) in participants with CI vs those without. It is scored from 0-100 where a lower score indicates worse quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>1-3 days post-surgery</time_frame>
      <description>The incidence of postoperative delirium as assessed by the Confusion Assessment Method (CAM) conducted by the nursing team and through medical chart review.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>1-3 days post-surgery</time_frame>
      <description>Postoperative complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>1-3 days post-surgery</time_frame>
      <description>Hospital length of stay (LOS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>1-3 days post-surgery</time_frame>
      <description>Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>30- and 90-days post-surgery</time_frame>
      <description>Mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>30- and 90-days post-surgery</time_frame>
      <description>Readmission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcomes post-surgery</measure>
      <time_frame>30- and 90-days post-surgery</time_frame>
      <description>Postoperative complications</description>
    </secondary_outcome>
    <enrollment type="Anticipated">213</enrollment>
    <condition>Cognitive Impairment (CI)</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients scheduled to undergo elective inpatient non-cardiac surgery under general and/ or&#xD;
          regional anesthesia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients ≥ 65 years old;&#xD;
  &#xD;
            -  competent to provide informed consent in English;&#xD;
  &#xD;
            -  undergoing elective non-cardiac surgery;&#xD;
  &#xD;
            -  education ≥ 8 years;&#xD;
  &#xD;
            -  able to be contacted by telephone.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous neurocognitive disorder (e.g., dementia) diagnosis;&#xD;
  &#xD;
            -  uncontrolled psychiatric disorders;&#xD;
  &#xD;
            -  hearing and/or vision impairment;&#xD;
  &#xD;
            -  unable to write or hold pen;&#xD;
  &#xD;
            -  undergoing neurosurgery;&#xD;
  &#xD;
            -  unable to provide informed consent.&#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>Frances Chung, MBBS FRCPC</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Health Network, Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sazzadul Islam</last_name>
      <phone>4166622686</phone>
      <email>sazzadul.islam@uhn.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5T2S8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sazzadul Islam, M.Sc.</last_name>
        <phone>416 662 2686</phone>
        <email>sazzadul.islam@uhn.ca</email>
      </contact>
      <investigator>
        <last_name>Frances Chung, MBBS FRCPC</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sazzadul Islam</last_name>
        <phone>14166622686</phone>
        <email>sazzadul.islam@uhn.ca</email>
      </contact>
      <investigator>
        <last_name>David He, MD PhD FRCPC</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <!-- 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/NCT06030765
  org study id: 22-5810
  nct id: NCT06030765
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a prospective multicenter cohort study which will evaluate rapid (administration time
        ≤ 5 minutes) cognitive screening tools that can be administered preoperatively in older
        patients undergoing noncardiac surgery. Namely, our study will determine the diagnostic
        accuracy (sensitivity, specificity, and area under the curves [AUC]) of two rapid, easily
        administered cognitive screening tools: the Mini-Cog and the Ascertain Dementia 8-item
        Questionnaire (AD8) against the Montreal Cognitive Assessment (MoCA). Additionally, we will
        examine the prevalence of cognitive impairment (CI) in patients meeting the CI criteria by
        either the AD8, Mini-Cog, or MoCA and the prevalence of elevated levels of plasma biomarker
        of phosphorylated tau 181 (pTau181) and neurofilament-light chain (NfL) in the patients
        meeting the CI criteria. This study will target older patients from surgical offices and/or
        pre-admission clinics at Toronto General (TGH), Toronto Western (TWH), and Mount Sinai
        Hospital (MSH), Toronto, Ontario. The identification and recruitment of eligible patients
        will be a collaborative effort between the nurses, surgeons, anesthesiologists, and the
        research team. Written informed consent to participate in the study will be obtained from all
        patients.
  The primary aims of the study is to (1) determine the diagnostic accuracy (sensitivity,
        specificity, and the AUC) of two rapid cognitive screening tools (AD8 and Mini-Cog) against
        the MoCA in the older surgical population and (2) determine the prevalence of CI as detected
        by the cognitive screening tests (AD8, Mini-Cog, or MoCA) and to determine the prevalence of
        elevated plasma biomarkers associated with neurodegenerative and/or vascular diseases using
        plasma (pTau181 or NfL) biomarkers in those with CI as detected by the screening tools. The
        secondary aims are to (1) describe the distribution of plasma pTau181 or NfL biomarkers in
        patients meeting the CI criteria by the AD8, Mini-Cog, or MoCA, (2) compare the trajectory of
        patient-reported outcomes at baseline, 30-, and 90-day post-surgery in patients with or
        without CI as detected by the cognitive screening tests, and (3) compare clinical outcomes in
        patients with or without CI as detected by the cognitive screening tests.
  
        The study consists of four consecutive time points, including one preoperative assessment and
        three postoperative assessments occurring during participants' hospital stay and at 30- and
        90-day post-surgery. In the preoperative assessment 1-30 days before their scheduled surgery,
        patients will be asked to complete the AD8, Mini-Cog, MoCA and the STOP-Bang Questionnaire
        in-person. If a patient screens positive on one or more of the three cognitive screening
        tools, they will have blood drawn for pTau181 and NfL bioassay analysis. Additionally,
        patients will be asked to complete the following assessments via an online survey or over the
        telephone prior to their scheduled surgery: WHODAS-2.0 (World Health Organization Disability
        Assessment Schedule 2.0), 5-item FRAIL Questionnaire, PHQ-4 (4-Item Patient Health
        Questionnaire for Anxiety and depression), VAS (visual analog scale) pain, SQS (Single Item
        Sleep Quality Scale), and a single question on QoL (quality of life).
  
        The first postoperative time point will occur during participants' stay at the hospital in
        which postoperative delirium (POD), postoperative complications, length of stay (LOS), and
        discharge destination will be assessed. At 30- and 90-day postoperatively, chart review will
        be performed to assess clinical outcomes, such as postoperative complications, all-cause
        mortality, and hospital readmission. Patient-reported outcomes, including WHODAS 2.0, 5-item
        FRAIL Questionnaire, PHQ-4, VAS pain, and QoL, will also be assessed through an online survey
        or over the telephone.
  observational model: Cohort
  time perspective: Prospective
  measure: The diagnostic accuracy (sensitivity, specificity, and AUC)
  time frame: Pre-surgery
  description: The diagnostic accuracy (sensitivity and specificity) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).
  measure: The diagnostic accuracy (sensitivity, specificity, and AUC)
  time frame: Pre-surgery
  description: The AUC (Area under the Receiver Operating Characteristic Curve (ROC)) of the AD8 (Eight-item Interview to Differentiate Aging and Dementia) and Mini-Cog against the MoCA (Montreal Cognitive Assessment).
  measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
  time frame: Pre-surgery
  description: The prevalence of CI as detected by the AD8 (Eight-item Interview to Differentiate Aging and Dementia). The AD8 is scored from 0-8 with a score of two or more indicating cognitive impairment.
  measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
  time frame: Pre-surgery
  description: The prevalence of CI as detected by the Mini-Cog. The Mini-Cog is scored from 0-5 with a score of two or less indicating cognitive impairment.
  measure: Prevalence of cognitive impairment (CI) via cognitive screening tools
  time frame: Pre-surgery
  description: The prevalence of CI as detected by the MoCA (Montreal Cognitive Assessment). The MoCA is scored from 0-30 with a score of 25 or less indicating cognitive impairment.
  measure: Prevalence of elevated plasma biomarkers
  time frame: Pre-surgery
  description: The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma pTau181 biomarkers in those with CI as detected by the screening tools.
  measure: Prevalence of elevated plasma biomarkers
  time frame: Pre-surgery
  description: The prevalence of elevated plasma biomarkers associated with neurogenerative and/or vascular diseases using plasma NfL biomarkers in those with CI as detected by the screening tools.
  measure: Distribution of plasma biomarkers
  time frame: Pre-surgery
  description: The distribution of plasma pTau181 biomarkers in patients meeting the CI criteria by the cognitive screening tools.
  measure: Distribution of plasma biomarkers
  time frame: Pre-surgery
  description: The distribution of plasma NfL biomarkers in patients meeting the CI criteria by the cognitive screening tools.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery, 30- and 90-days post-surgery
  description: The trajectory and prevalence or incidence of functional disability as measured through the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0) in participants with CI vs those without. A five-point rating scale is used for each question (none = 0, mild = 1, moderate = 2, severe = 3, extreme/cannot do = 4), and a higher WHODAS score indicates greater disability.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery, 30- and 90-days post-surgery
  description: The trajectory and prevalence or incidence of frailty as measured through the 5-item FRAIL questionnaire in participants with CI vs those without. It is scored from 0-5 where higher scores indicate frailty.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery, 30- and 90-days post-surgery
  description: The trajectory and prevalence or incidence of pain as measured through the VAS Pain (Visual Analog Scale for Pain) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates worse pain.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery, 30- and 90-days post-surgery
  description: The trajectory and prevalence or incidence of depression and anxiety as measured through the PHQ-4 (4-Item Patient Health Questionnaire) in participants with CI vs those without. It is scored from 0-12 where a higher score indicates depression and anxiety.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery
  description: The trajectory and prevalence or incidence of obstructive sleep apnea (OSA) as measured through the STOP-Bang Questionnaire in participants with CI vs those without. It is scored from 0-8 where a higher score indicates higher risk for OSA.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery
  description: The trajectory and prevalence or incidence of sleep disturbances as measured through the SQS (Single Item Sleep Quality Scale) in participants with CI vs those without. It is scored from 0-10 where a lower score indicates sleep disturbances.
  measure: Trajectories and prevalence or incidence of patient-reported outcomes pre-surgery
  time frame: Pre-surgery, 30- and 90-days post-surgery
  description: The trajectory and prevalence or incidence of quality of life as measured through the single question on Quality of Life (QoL) in participants with CI vs those without. It is scored from 0-100 where a lower score indicates worse quality of life.
  measure: Clinical outcomes post-surgery
  time frame: 1-3 days post-surgery
  description: The incidence of postoperative delirium as assessed by the Confusion Assessment Method (CAM) conducted by the nursing team and through medical chart review.
  measure: Clinical outcomes post-surgery
  time frame: 1-3 days post-surgery
  description: Postoperative complications
  measure: Clinical outcomes post-surgery
  time frame: 1-3 days post-surgery
  description: Hospital length of stay (LOS)
  measure: Clinical outcomes post-surgery
  time frame: 1-3 days post-surgery
  description: Discharge destination (assess where the participant will be discharged to once out of hospital up to 30-days post-op)
  measure: Clinical outcomes post-surgery
  time frame: 30- and 90-days post-surgery
  description: Mortality
  measure: Clinical outcomes post-surgery
  time frame: 30- and 90-days post-surgery
  description: Readmission
  measure: Clinical outcomes post-surgery
  time frame: 30- and 90-days post-surgery
  description: Postoperative complications
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frances Chung, MBBS FRCPC
  role: Principal Investigator
  affiliation: University Health Network, Toronto
  last name: Sazzadul Islam
  phone: 4166622686
  email: sazzadul.islam@uhn.ca
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction