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/NCT06006000</url>
    </required_header>
    <id_info>
      <org_study_id>2000034943</org_study_id>
      <secondary_id>1R01AG079916-01A1</secondary_id>
      <nct_id>NCT06006000</nct_id>
    </id_info>
    <brief_title>Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness</brief_title>
    <acronym>LANTERN</acronym>
    <official_title>Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective longitudinal study that will evaluate the unmet needs of older adults&#xD;
        (65 and older) who return home (either directly or after short-term rehab) after an ICU&#xD;
        hospitalization, evaluate the association of these unmet needs with clinically relevant&#xD;
        outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed&#xD;
        research will inform the development and evaluation of a subsequent intervention to improve&#xD;
        functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce&#xD;
        disability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To identify unmet needs in multiple domains after return home from an ICU hospitalization,&#xD;
        evaluate whether these unmet needs are associated with disability burden in the subsequent 6&#xD;
        months, and ascertain whether these associations are moderated by initial discharge&#xD;
        destination (home or STR).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2028</completion_date>
    <primary_completion_date type="Anticipated">October 2028</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>Disability Count</measure>
      <time_frame>monthly up to 6 months</time_frame>
      <description>Number of instances of disability during activities of daily living (ADLs), instrumental activities of daily living (IADLs), and mobility activity. Disability is defined as an inability to complete the task or the need for personal assistance to complete the task. The higher the count, the more disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of hospital readmissions</measure>
      <time_frame>monthly up to 6 months</time_frame>
      <description>Number of hospital readmissions monthly up to 6 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of deaths</measure>
      <time_frame>monthly up to 6 months</time_frame>
      <description>Number of deaths each month up to 6 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Barriers and Facilitators to addressing unmet needs</measure>
      <time_frame>month 6</time_frame>
      <description>Barriers and facilitators to addressing unmet needs will be assessed using qualitative interviews. A subgroup of participants will receive qualitative interviews conducted with members of the study team. Content analysis will then be used to identify barriers and facilitators to addressing unmet needs that will be informative when planning a future intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional non-recovery</measure>
      <time_frame>monthly up to 6 months</time_frame>
      <description>Not returning to the pre-ICU functional baseline within the follow-up period</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">650</enrollment>
    <condition>Critical Illness</condition>
    <condition>Illness, Critical</condition>
    <arm_group>
      <arm_group_label>Older adults returning home post-ICU</arm_group_label>
      <description>Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Community-dwelling older adults who return home (either directly or after a stay in&#xD;
          short-term rehab (STR)) after an ICU hospitalization.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          PARTICIPANTS&#xD;
  &#xD;
            -  Age ≥ 65 years&#xD;
  &#xD;
            -  Survived an ICU admission of ≥2 days&#xD;
  &#xD;
          CAREGIVERS&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          PARTICIPANTS&#xD;
  &#xD;
            -  Advance directive of comfort measures only (CMO) or a transition to hospice&#xD;
  &#xD;
            -  Planned discharge to a location other than home or Short-Term Rehab&#xD;
  &#xD;
            -  Tracheostomy with ventilator dependence&#xD;
  &#xD;
            -  Severe acute or prior neurologic injury (such as anoxic brain injury or acute, massive&#xD;
               stroke)&#xD;
  &#xD;
            -  Advanced dementia&#xD;
  &#xD;
            -  ICU admission for monitoring only (e.g., antibiotic desensitization)&#xD;
  &#xD;
            -  Primary language other than English.&#xD;
  &#xD;
          CAREGIVERS&#xD;
  &#xD;
            -  Primary language other than English&#xD;
  &#xD;
            -  Is a paid caregiver&#xD;
  &#xD;
            -  Unwilling to complete a qualitative interview&#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>Lauren Ferrante, MD, MHS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nicole Bouranis, PhD</last_name>
      <phone>+1 (203) 737-1768</phone>
      <email>nicole.bouranis@yale.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Yale New Haven Hospital</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06520</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Geriatrics</keyword>
    <keyword>Older Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified data from this study will be available to investigators who sign a Data Use Agreement (DUA) executed between Yale University and the investigator's institution. The DUA requires the investigators to attest to (1) their commitment to using the data only for approved research purposes and not to identify any individual human participant; (2) their commitment to securing the data using appropriate computer technology; and (3) their commitment to destroying or returning the data after analyses are completed.&#xD;
  Data will not be available until all analyses are complete.</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/NCT06006000
  org study id: 2000034943
  secondary id: 1R01AG079916-01A1
  nct id: NCT06006000
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective longitudinal study that will evaluate the unmet needs of older adults
        (65 and older) who return home (either directly or after short-term rehab) after an ICU
        hospitalization, evaluate the association of these unmet needs with clinically relevant
        outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed
        research will inform the development and evaluation of a subsequent intervention to improve
        functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce
        disability.
  To identify unmet needs in multiple domains after return home from an ICU hospitalization,
        evaluate whether these unmet needs are associated with disability burden in the subsequent 6
        months, and ascertain whether these associations are moderated by initial discharge
        destination (home or STR).
  observational model: Cohort
  time perspective: Prospective
  measure: Disability Count
  time frame: monthly up to 6 months
  description: Number of instances of disability during activities of daily living (ADLs), instrumental activities of daily living (IADLs), and mobility activity. Disability is defined as an inability to complete the task or the need for personal assistance to complete the task. The higher the count, the more disability.
  measure: Number of hospital readmissions
  time frame: monthly up to 6 months
  description: Number of hospital readmissions monthly up to 6 months.
  measure: Number of deaths
  time frame: monthly up to 6 months
  description: Number of deaths each month up to 6 months.
  measure: Barriers and Facilitators to addressing unmet needs
  time frame: month 6
  description: Barriers and facilitators to addressing unmet needs will be assessed using qualitative interviews. A subgroup of participants will receive qualitative interviews conducted with members of the study team. Content analysis will then be used to identify barriers and facilitators to addressing unmet needs that will be informative when planning a future intervention.
  measure: Functional non-recovery
  time frame: monthly up to 6 months
  description: Not returning to the pre-ICU functional baseline within the follow-up period
  arm group label: Older adults returning home post-ICU
  description: Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lauren Ferrante, MD, MHS
  role: Principal Investigator
  affiliation: Yale School of Medicine
  last name: Nicole Bouranis, PhD
  phone: +1 (203) 737-1768
  email: nicole.bouranis@yale.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Critical Illness
  sharing ipd: Yes
  ipd description: Deidentified data from this study will be available to investigators who sign a Data Use Agreement (DUA) executed between Yale University and the investigator's institution. The DUA requires the investigators to attest to (1) their commitment to using the data only for approved research purposes and not to identify any individual human participant; (2) their commitment to securing the data using appropriate computer technology; and (3) their commitment to destroying or returning the data after analyses are completed.
  Data will not be available until all analyses are complete.