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/NCT05999903</url>
    </required_header>
    <id_info>
      <org_study_id>1R21AG080339-01</org_study_id>
      <secondary_id>1R21AG080339-01</secondary_id>
      <nct_id>NCT05999903</nct_id>
    </id_info>
    <brief_title>Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors</brief_title>
    <acronym>DRIVE-PICS</acronym>
    <official_title>Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Wisconsin, Madison</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vanderbilt University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Baylor Research Institute</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>
        Older adults are at risk for ICU-acquired cognitive decline discernible from clinical,&#xD;
        biological, and imaging- related changes in the brain following delirium and critical&#xD;
        illness. Our Driving Rehabilitation and Innovation for Evaluating Risk in Post Intensive Care&#xD;
        Unit Survivors (DRIVE-PICS) application seeks to implement in-vehicle kinematic driving data&#xD;
        with neurocognitive assessments for essential formative work to develop data-based insights&#xD;
        into driving behaviors. DRIVE-PICS is designed to contribute to a critical gap in health&#xD;
        promotion to develop an evidence-based, in-vehicle driving assessment system to provide&#xD;
        actionable driving safety data and rehabilitation strategies tailored to older ICU survivors,&#xD;
        the participants' care partners, and clinicians.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There are more than 50 million older adults licensed to drive in the United States. Driving&#xD;
        is a complex task requiring cognitive and sensorimotor skills. Survivors of critical illness&#xD;
        experience cognitive, psychological and physical impairments, known as Post-Intensive Care&#xD;
        Syndrome (PICS), that can last months to years following critical illness. Across the&#xD;
        lifespan, ICU recovery has far-reaching implications for independent functioning, employment,&#xD;
        and healthcare utilization, costing billions annually. Older adults are at risk for ICU-&#xD;
        acquired cognitive decline discernible from clinical, biological, and imaging-related changes&#xD;
        in the brain following delirium and critical illness. Similar to other forms of dementia, the&#xD;
        combination of normal aging paired with cognitive deficits associated with critical illness&#xD;
        survivorship places these older adults at high risk of automobile crashes. To address&#xD;
        ICU-acquired cognitive decline, driving assessments to characterize risky driving behaviors&#xD;
        are promising to guide driving rehabilitation and intervention development. Rigorous and&#xD;
        reproducible driving safety assessment programs have demonstrated success in post-stroke and&#xD;
        dementia contexts, established via in-vehicle and virtual modes. The investigators&#xD;
        hypothesize that in-vehicle driving assessment and monitoring is a feasible and acceptable&#xD;
        approach to assess and address ICU survivor driving safety. The investigators seek to&#xD;
        implement novel in-vehicle cloud-data collection technology developed by the investigators'&#xD;
        team. The investigators propose to pair neurocognitive assessments with in-vehicle kinematic&#xD;
        driving data to conduct essential formative work to develop data-based insights into driving&#xD;
        behaviors of older adults with ICU-acquired cognitive declines. The investigators aim to&#xD;
        determine protocol feasibility and acceptability of neurocognitive assessments and in-vehicle&#xD;
        sensor deployment (Aim 1). The investigators will enroll a cohort of older ICU survivors&#xD;
        (n=24) with risk factors for ICU-acquired cognitive impairment to complete neurocognitive&#xD;
        measures and participate in driving data collection via in-vehicle sensors over a 6-month&#xD;
        post-hospital discharge period. Next, the investigators will evaluate the relationship&#xD;
        between neurocognitive assessments and driving behavior and safety in older ICU survivors&#xD;
        (Aim 2). Lastly, the investigators will conduct stakeholder advisory panels on the priorities&#xD;
        and data presentation needs of driving assessments for older ICU survivors (Aim 3). The&#xD;
        stakeholder advisory panel insights will provide scientific justification and protocol&#xD;
        feasibility to evaluate recruitment, acceptability and attrition for future full-scale&#xD;
        implementation. As the population of older drivers grows, almost doubling in size from 2012&#xD;
        to 2040 there is an immediate and critical need to address this impactful issue. This work is&#xD;
        designed in response to the NIA Strategic Plan (Goal C-1-9 Safety of Older Drivers) to&#xD;
        contribute to a critical gap in health promotion to develop an evidence-based, in- vehicle&#xD;
        driving assessment system to provide actionable driving safety data and rehabilitation&#xD;
        strategies tailored to ICU survivors, the participants' care partners and clinicians.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Total Driving Time</measure>
      <time_frame>0-6 months after hospital discharge</time_frame>
      <description>Total driving time in minutes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms. Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days. Higher scores indicate greater depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Executive Function</measure>
      <time_frame>3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Executive Function will be measured using the Dimensional Change Card Sort. The participant will be required to sort first according to one dimension (e.g., color) and then according to another dimension (e.g., shape).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attention</measure>
      <time_frame>3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Attention will be measured using the Flanker Inhibitory Control and Attention Test. The participants will be required to focus on a given stimulus while inhibiting attention to stimuli. Sometimes the middle stimulus points in the same direction as the &quot;flankers&quot; (congruent) and sometimes in the opposite direction (incongruent). if a participant scores ≥ 90%, 20 additional trials with arrows are presented.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Memory</measure>
      <time_frame>3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Working memory will be measured using the List Sorting Test. Participants will be provided pictures of different foods and animals accompanied with an audio recording as well as written text. The participant will be asked to recall the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Processing Speed</measure>
      <time_frame>3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Processing Speed will be measured using the Pattern Comparison Processing Speed Test. Participants are asked to quickly determine whether two stimuli are the same or not the same. The participants' score will be based on how many items they answer correctly out of a possible 130 items, completed in 90 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-Related Quality of Life</measure>
      <time_frame>Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Health-Related Quality of Life will be measured using the EuroQol- 5 Dimension Test (EQ-5D). The participant will be required to answer one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within the questionnaire, the participants will also be asked to rate their perception of how their health is on a scale of 0 (worst possible health status) to 100 (best possible health status). Questions are scored as a 1 (full health) and 0 (poorest health). With 0 being the worst health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms. Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days. Higher scores indicate greater depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Employment</measure>
      <time_frame>Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge</time_frame>
      <description>Employment will be measured through the Johns Hopkins OACIS Employment Questionnaire. It is not a scored questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Driving Trips</measure>
      <time_frame>0-6 months after hospital discharge</time_frame>
      <description>Driving trips will be measured using the number of trips the participant takes from the beginning of ignition to the end when the vehicle is turned off.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Driving Behaviors</measure>
      <time_frame>0-6 months after hospital discharge</time_frame>
      <description>Driving behaviors will be measured using near-crash events that are detected with validated accelerometer thresholds.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Delirium</condition>
    <condition>Critical Illness</condition>
    <condition>Drive</condition>
    <arm_group>
      <arm_group_label>Observational Kinematic Driving Data</arm_group_label>
      <description>Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          ICU survivors&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 55 and older.&#xD;
  &#xD;
            -  Must have had an ICU stay with delirium.&#xD;
  &#xD;
            -  Expected to survive hospital discharge.&#xD;
  &#xD;
            -  English proficiency&#xD;
  &#xD;
            -  Active driver within 4 weeks prior to index hospitalization&#xD;
  &#xD;
            -  Regular use of vehicle that is model year 1996 or newer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Communication challenges due to severe pre-existing dementia, hearing, or vision&#xD;
               impairment.&#xD;
  &#xD;
            -  No access to driving.&#xD;
  &#xD;
            -  Loss or suspension of driver's license&#xD;
  &#xD;
            -  Current Incarceration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Valerie Danesh, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baylor Scott and White Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Valerie Danesh, PhD</last_name>
      <phone>2547714853</phone>
      <email>CAHRcriticalcare@bswhealth.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Baylor Scott and White Health Medical Center At Temple</name>
        <address>
          <city>Temple</city>
          <state>Texas</state>
          <zip>76508</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michaela Gladden, B.S.</last_name>
        <phone>254-771-4853</phone>
        <email>CAHRcriticalcare@bswhealth.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adult</keyword>
    <keyword>Human</keyword>
    <keyword>Vehicle Driving</keyword>
    <keyword>Functional Outcomes</keyword>
    <keyword>Post-Intensive Care Syndrome (PICS)</keyword>
    <keyword>Neuro-Psychological</keyword>
    <keyword>Cognitive</keyword>
    <keyword>Neuro Cognitive</keyword>
    <keyword>Intensive Care Unit (ICU)</keyword>
    <keyword>Longitudinal</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>Undecided</sharing_ipd>
      <ipd_description>No study documents available.</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/NCT05999903
  org study id: 1R21AG080339-01
  secondary id: 1R21AG080339-01
  nct id: NCT05999903
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Older adults are at risk for ICU-acquired cognitive decline discernible from clinical,
        biological, and imaging- related changes in the brain following delirium and critical
        illness. Our Driving Rehabilitation and Innovation for Evaluating Risk in Post Intensive Care
        Unit Survivors (DRIVE-PICS) application seeks to implement in-vehicle kinematic driving data
        with neurocognitive assessments for essential formative work to develop data-based insights
        into driving behaviors. DRIVE-PICS is designed to contribute to a critical gap in health
        promotion to develop an evidence-based, in-vehicle driving assessment system to provide
        actionable driving safety data and rehabilitation strategies tailored to older ICU survivors,
        the participants' care partners, and clinicians.
  There are more than 50 million older adults licensed to drive in the United States. Driving
        is a complex task requiring cognitive and sensorimotor skills. Survivors of critical illness
        experience cognitive, psychological and physical impairments, known as Post-Intensive Care
        Syndrome (PICS), that can last months to years following critical illness. Across the
        lifespan, ICU recovery has far-reaching implications for independent functioning, employment,
        and healthcare utilization, costing billions annually. Older adults are at risk for ICU-
        acquired cognitive decline discernible from clinical, biological, and imaging-related changes
        in the brain following delirium and critical illness. Similar to other forms of dementia, the
        combination of normal aging paired with cognitive deficits associated with critical illness
        survivorship places these older adults at high risk of automobile crashes. To address
        ICU-acquired cognitive decline, driving assessments to characterize risky driving behaviors
        are promising to guide driving rehabilitation and intervention development. Rigorous and
        reproducible driving safety assessment programs have demonstrated success in post-stroke and
        dementia contexts, established via in-vehicle and virtual modes. The investigators
        hypothesize that in-vehicle driving assessment and monitoring is a feasible and acceptable
        approach to assess and address ICU survivor driving safety. The investigators seek to
        implement novel in-vehicle cloud-data collection technology developed by the investigators'
        team. The investigators propose to pair neurocognitive assessments with in-vehicle kinematic
        driving data to conduct essential formative work to develop data-based insights into driving
        behaviors of older adults with ICU-acquired cognitive declines. The investigators aim to
        determine protocol feasibility and acceptability of neurocognitive assessments and in-vehicle
        sensor deployment (Aim 1). The investigators will enroll a cohort of older ICU survivors
        (n=24) with risk factors for ICU-acquired cognitive impairment to complete neurocognitive
        measures and participate in driving data collection via in-vehicle sensors over a 6-month
        post-hospital discharge period. Next, the investigators will evaluate the relationship
        between neurocognitive assessments and driving behavior and safety in older ICU survivors
        (Aim 2). Lastly, the investigators will conduct stakeholder advisory panels on the priorities
        and data presentation needs of driving assessments for older ICU survivors (Aim 3). The
        stakeholder advisory panel insights will provide scientific justification and protocol
        feasibility to evaluate recruitment, acceptability and attrition for future full-scale
        implementation. As the population of older drivers grows, almost doubling in size from 2012
        to 2040 there is an immediate and critical need to address this impactful issue. This work is
        designed in response to the NIA Strategic Plan (Goal C-1-9 Safety of Older Drivers) to
        contribute to a critical gap in health promotion to develop an evidence-based, in- vehicle
        driving assessment system to provide actionable driving safety data and rehabilitation
        strategies tailored to ICU survivors, the participants' care partners and clinicians.
  observational model: Cohort
  time perspective: Prospective
  measure: Total Driving Time
  time frame: 0-6 months after hospital discharge
  description: Total driving time in minutes.
  measure: Depression
  time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
  description: Depression will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms. Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days. Higher scores indicate greater depression.
  measure: Executive Function
  time frame: 3 months after hospital discharge, 6 months after hospital discharge
  description: Executive Function will be measured using the Dimensional Change Card Sort. The participant will be required to sort first according to one dimension (e.g., color) and then according to another dimension (e.g., shape).
  measure: Attention
  time frame: 3 months after hospital discharge, 6 months after hospital discharge
  description: Attention will be measured using the Flanker Inhibitory Control and Attention Test. The participants will be required to focus on a given stimulus while inhibiting attention to stimuli. Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent). if a participant scores ≥ 90%, 20 additional trials with arrows are presented.
  measure: Working Memory
  time frame: 3 months after hospital discharge, 6 months after hospital discharge
  description: Working memory will be measured using the List Sorting Test. Participants will be provided pictures of different foods and animals accompanied with an audio recording as well as written text. The participant will be asked to recall the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List).
  measure: Processing Speed
  time frame: 3 months after hospital discharge, 6 months after hospital discharge
  description: Processing Speed will be measured using the Pattern Comparison Processing Speed Test. Participants are asked to quickly determine whether two stimuli are the same or not the same. The participants' score will be based on how many items they answer correctly out of a possible 130 items, completed in 90 seconds.
  measure: Health-Related Quality of Life
  time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
  description: Health-Related Quality of Life will be measured using the EuroQol- 5 Dimension Test (EQ-5D). The participant will be required to answer one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within the questionnaire, the participants will also be asked to rate their perception of how their health is on a scale of 0 (worst possible health status) to 100 (best possible health status). Questions are scored as a 1 (full health) and 0 (poorest health). With 0 being the worst health status.
  measure: Anxiety
  time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
  description: Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report of depression symptoms. Participants rate each item from 0 (not at all) to 3 (very often) to indicate the degree to which they have experienced the symptom in the past 7 days. Higher scores indicate greater depression.
  measure: Employment
  time frame: Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge
  description: Employment will be measured through the Johns Hopkins OACIS Employment Questionnaire. It is not a scored questionnaire.
  measure: Driving Trips
  time frame: 0-6 months after hospital discharge
  description: Driving trips will be measured using the number of trips the participant takes from the beginning of ignition to the end when the vehicle is turned off.
  measure: Driving Behaviors
  time frame: 0-6 months after hospital discharge
  description: Driving behaviors will be measured using near-crash events that are detected with validated accelerometer thresholds.
  arm group label: Observational Kinematic Driving Data
  description: Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Valerie Danesh, PhD
  role: Principal Investigator
  affiliation: Baylor Scott and White Research Institute
  last name: Valerie Danesh, PhD
  phone: 2547714853
  email: CAHRcriticalcare@bswhealth.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Critical Illness
  sharing ipd: Undecided
  ipd description: No study documents available.