<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/NCT03284437</url>
  </required_header>
  <id_info>
    <org_study_id>170214-3</org_study_id>
    <nct_id>NCT03284437</nct_id>
  </id_info>
  <brief_title>Pilot Study of Early Cognitive Training in the Intensive Care Unit</brief_title>
  <acronym>ECTICU</acronym>
  <official_title>Pilot Study of Early Cognitive Training in the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Carmel Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Carmel Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see how early cognitive training (participation/involvement&#xD;
      in activities to stimulate the brain) in the Intensive Care Unit (ICU) affects the number of&#xD;
      patients who experience delirium (confusion) and cognitive impairment (problems with&#xD;
      thinking). Reports have shown that 30% to 80% of all ICU patients will have some type of&#xD;
      cognitive impairment: remembering, paying attention, solving problems, organizing, and&#xD;
      working on complex tasks for some time after they leave the hospital.&#xD;
&#xD;
      Occupational therapy will do an assessment after an order is received from the doctor. The&#xD;
      patient will be randomly placed into one of two groups. If the patient is in group A then&#xD;
      they will continue with occupational therapy as normal. If the patient is assigned to group B&#xD;
      then they and the family will have access to an activity cart found there in the ICU unit,&#xD;
      directed by the nurses. The family will work with the patient on a daily basis to complete&#xD;
      activities that are appropriate for the patient based on the occupational therapist's&#xD;
      assessment. All patients in the study will receive medical care as usual.&#xD;
&#xD;
      Information about the patient's recovery in the hospital will be collected. In addition,&#xD;
      patients and/or their family member will complete surveys at 6 months and 1 year after&#xD;
      enrollment to see how they have recovered and if there are continuing issues. The two groups&#xD;
      of patients, those who received the early cognitive training and those who did not, will be&#xD;
      compared statistically to see if there are any differences in how well they recovered. Since&#xD;
      this intervention involving family members working with the patient has not previously been&#xD;
      evaluated, the study will also examine the feasibility of conducting these activities in the&#xD;
      ICU setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will assess the feasibility of implementing a randomized clinical trial&#xD;
      testing an early cognitive training program for patients in the ICU. This cognitive training&#xD;
      program was developed at Mount Carmel Health System in conjunction with occupational&#xD;
      therapists and has not been previously evaluated.&#xD;
&#xD;
      Specific Aim 1: To evaluate whether the trial can accrue a sufficient number of patients&#xD;
      within a reasonable time period to complete a randomized trial for efficacy.&#xD;
&#xD;
      Specific Aim 2: To evaluate whether the trial can be conducted as designed.&#xD;
&#xD;
      Specific Aim 3: To evaluate the likelihood that the trial can retain a sufficient number of&#xD;
      patients through the end of follow-up.&#xD;
&#xD;
      Assessments include the Montreal Cognitive Assessment Test (MoCA), Richmond Agitation and&#xD;
      Sedation Scale (RASS), Confusion Assessment Method in the ICU (CAM-ICU) and a validated&#xD;
      quality of life survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Logistical difficulties with implementing study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Actual">April 26, 2021</completion_date>
  <primary_completion_date type="Actual">April 26, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessor is not participating in patient enrollment or administration of study intervention and will not be aware of study group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Enrollment</measure>
    <time_frame>3 Days</time_frame>
    <description>Percent of eligible patients who are consented and enrolled into the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Receiving Intervention</measure>
    <time_frame>One month</time_frame>
    <description>Percent of patients randomized to intervention who receive intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment Score</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Montreal Cognitive Assessment score from baseline to 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Intensive Care Units, Delirium, Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual medical care provided to patients in the ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Cognitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual medical care provided to patients in the ICU plus additional activities designed to engage the patient's attention and cognition. Activities are chosen by the family member from an activity cart according to the level designated by occupation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early Cognitive Training</intervention_name>
    <description>Choose level of activity (e.g., coloring, holding objects) based on occupational therapist assessment.</description>
    <arm_group_label>Early Cognitive Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be in the intensive care unit, i.e., either the surgical intensive care&#xD;
             unit (SICU) or medical intensive care unit (MICU).&#xD;
&#xD;
          -  Patient must be ≥18 years old.&#xD;
&#xD;
          -  Predicted ICU length of stay greater than 3 days.&#xD;
&#xD;
          -  Patient with a RASS goal of -1 to +1 at time of enrollment.&#xD;
&#xD;
          -  Patient's family member(s) agree to do the cognitive training for a least one hour a&#xD;
             day (a series of items meant to focus and stretch cognitive ability) while in the ICU.&#xD;
             The hour can be done incrementally if needed. Family member should be ≥18 years old.&#xD;
&#xD;
          -  Family who can return to the hospital at the 6 month mark to take a final MOCA test&#xD;
             and complete a survey.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient presently on Versed, Diprivan or Ativan drips.&#xD;
&#xD;
          -  Patient with a history of cognitive impairment, current psychiatric diagnosis and not&#xD;
             stable on treatment, or developmental delay.&#xD;
&#xD;
          -  Patient with Alzheimer's or dementia.&#xD;
&#xD;
          -  Patient with known active substance abuse.&#xD;
&#xD;
          -  Patients without family support.&#xD;
&#xD;
          -  Patients without the ability to return to the hospital for the 6 month visit.&#xD;
&#xD;
          -  Patient with history of critical care illness within the last year from time of&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients who have been critically ill for greater than 72 hours.&#xD;
&#xD;
          -  Non-English speaking individuals restricting ability to follow instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terri Swan, BSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Carmel Health System</affiliation>
  </overall_official>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share at this time. This intervention is being evaluated for feasibility.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03284437
org study id: 170214-3
nct id: NCT03284437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see how early cognitive training (participation/involvement
      in activities to stimulate the brain) in the Intensive Care Unit (ICU) affects the number of
      patients who experience delirium (confusion) and cognitive impairment (problems with
      thinking). Reports have shown that 30% to 80% of all ICU patients will have some type of
      cognitive impairment: remembering, paying attention, solving problems, organizing, and
      working on complex tasks for some time after they leave the hospital.

      Occupational therapy will do an assessment after an order is received from the doctor. The
      patient will be randomly placed into one of two groups. If the patient is in group A then
      they will continue with occupational therapy as normal. If the patient is assigned to group B
      then they and the family will have access to an activity cart found there in the ICU unit,
      directed by the nurses. The family will work with the patient on a daily basis to complete
      activities that are appropriate for the patient based on the occupational therapist's
      assessment. All patients in the study will receive medical care as usual.

      Information about the patient's recovery in the hospital will be collected. In addition,
      patients and/or their family member will complete surveys at 6 months and 1 year after
      enrollment to see how they have recovered and if there are continuing issues. The two groups
      of patients, those who received the early cognitive training and those who did not, will be
      compared statistically to see if there are any differences in how well they recovered. Since
      this intervention involving family members working with the patient has not previously been
      evaluated, the study will also examine the feasibility of conducting these activities in the
      ICU setting.
This pilot study will assess the feasibility of implementing a randomized clinical trial
      testing an early cognitive training program for patients in the ICU. This cognitive training
      program was developed at Mount Carmel Health System in conjunction with occupational
      therapists and has not been previously evaluated.

      Specific Aim 1: To evaluate whether the trial can accrue a sufficient number of patients
      within a reasonable time period to complete a randomized trial for efficacy.

      Specific Aim 2: To evaluate whether the trial can be conducted as designed.

      Specific Aim 3: To evaluate the likelihood that the trial can retain a sufficient number of
      patients through the end of follow-up.

      Assessments include the Montreal Cognitive Assessment Test (MoCA), Richmond Agitation and
      Sedation Scale (RASS), Confusion Assessment Method in the ICU (CAM-ICU) and a validated
      quality of life survey.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Outcomes assessor is not participating in patient enrollment or administration of study intervention and will not be aware of study group assignment.
measure: Percent Enrollment
time frame: 3 Days
description: Percent of eligible patients who are consented and enrolled into the study.
measure: Percent Receiving Intervention
time frame: One month
description: Percent of patients randomized to intervention who receive intervention
measure: Montreal Cognitive Assessment Score
time frame: 6 months
description: Change in Montreal Cognitive Assessment score from baseline to 6 months
arm group label: Usual Care
arm group type: No Intervention
description: Usual medical care provided to patients in the ICU.
arm group label: Early Cognitive Training
arm group type: Experimental
description: Usual medical care provided to patients in the ICU plus additional activities designed to engage the patient's attention and cognition. Activities are chosen by the family member from an activity cart according to the level designated by occupation therapy.
intervention type: Behavioral
intervention name: Early Cognitive Training
description: Choose level of activity (e.g., coloring, holding objects) based on occupational therapist assessment.
arm group label: Early Cognitive Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Terri Swan, BSN
role: Principal Investigator
affiliation: Mount Carmel Health System
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: No plans to share at this time. This intervention is being evaluated for feasibility.