<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/NCT02230605</url>
  </required_header>
  <id_info>
    <org_study_id>2013H0388</org_study_id>
    <nct_id>NCT02230605</nct_id>
  </id_info>
  <brief_title>Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)</brief_title>
  <official_title>Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many individuals experience an acute change in thinking and reasoning skills after surgery.&#xD;
      This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after&#xD;
      surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study&#xD;
      is to determine if performing mental exercise, before surgery, will help reduce post-surgery&#xD;
      memory and thinking problems. Assuming a 30% incidence of PD and proposed 50% reduction of PD&#xD;
      in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each&#xD;
      group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I&#xD;
      error rate. Assuming approximately 1/3 of consented patients either fail screening or do not&#xD;
      complete the study after consent, we expect to consent 358 patients.&#xD;
&#xD;
      At least 8 days before surgery, subjects complete a series of questionnaires to assess&#xD;
      baseline cognition level (or thinking ability) and status of overall well-being. At the&#xD;
      completion of the screening visit, qualifying subjects are randomized into two groups:&#xD;
&#xD;
      Participants randomized into the Cognitive Exercise group are expected to complete&#xD;
      tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for&#xD;
      the duration of the preoperative period. Participants in this group are expected to complete&#xD;
      a minimum of 10 hours within at least 8 days prior to surgery.&#xD;
&#xD;
      Participants randomized into the Normal Activity group are encouraged to carry out their&#xD;
      baseline daily activities, and do not have any study-related cognitive exercise expectations&#xD;
      before surgery. These subjects still complete the same questionnaires and assessments as the&#xD;
      Cognitive Exercise group throughout the study, however, are asked not to alter their normal&#xD;
      daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are&#xD;
      not permitted to subscribe to Lumosity while in the research study.&#xD;
&#xD;
      On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is&#xD;
      taken before surgery. During surgery, research personnel monitor vital signs and medications&#xD;
      given. After surgery, another CAM evaluation is taken in the post-operative recovery room.&#xD;
&#xD;
      Throughout the subject's hospital stay, pain levels and medication usage are recorded. The&#xD;
      CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity&#xD;
      of PD. The evaluations are given twice daily, at at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs,&#xD;
      for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of&#xD;
      Recovery Scale (PQRS) is used each post-operative day at 6:30PM ± 1.5 hrs until discharge,&#xD;
      and completed over the phone on POD 7 if patient discharged. The PQRS is also administered&#xD;
      over the phone on POD 30 and POD 90.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential study participants will be identified one of two ways, either by the treating&#xD;
      physician in clinic when the decision is made to pursue surgery or by researchers monitoring&#xD;
      the OR schedule. When a potential participant is identified by the treating physician in&#xD;
      clinic, they will ask the patient if study personnel may call them to discuss the study. If&#xD;
      the patient agrees to be contacted, the surgeon will alert study personnel who will call the&#xD;
      patient to explain the study and arrange the initial study (screening) visit. Study personnel&#xD;
      will monitor the OR schedule and call any potential patients the surgeons have not already&#xD;
      identified in clinic. In this case, patients will be informed over the phone that their&#xD;
      surgeon has granted permission to contact them regarding the study. Surgeons will be made&#xD;
      aware when their patients have been approached over the phone, and updated accordingly if the&#xD;
      patient agrees to the screening visit and is subsequently enrolled in the study. All&#xD;
      screening visits will occur at the OSU Pre-operative Assessment Center (OPAC). When possible&#xD;
      the screening visit will co-inside with pre-operative testing per the Anesthesia Department&#xD;
      at OPAC.&#xD;
&#xD;
      Informed consent will occur at the initial screening visit which is to take place&#xD;
      approximately 2 weeks prior to surgery, but no less than 8 days pre-op. At this visit, a&#xD;
      member of the research team will obtain demographic information (gender, education level),&#xD;
      historical medical information, and information regarding medication usage. The researcher&#xD;
      will perform the Mini-Mental Status Exam (MMSE) - the modified version (see attached&#xD;
      document), Self Administered Gerocognitve Form (SAGE) - all four versions (see attached&#xD;
      questionnaires), Geriatric Depression Scale, Charlson Comorbidity Index, Postoperative&#xD;
      Quality Recovery Scale (PQRS), and Short-form 36 Health Related Quality of Life Measure.&#xD;
      Patients meeting inclusion criteria will be randomized to either the cognitive exercise or&#xD;
      control group. Patients in the cognitive exercise group will be given a tablet with&#xD;
      preinstalled access to Lumosity (Lumos Labs, San Francisco, CA, USA), a cognitive exercise&#xD;
      software application which will be used in this study. Each participant in the cognitive&#xD;
      exercise group will be expected to complete 1 hour of Lumosity brain exercise daily for a&#xD;
      minimum of 8 days prior to surgery, equaling an effective 'dose' at least 10 hours. Playing&#xD;
      time will be determined either by: (a) the actual in-game playing time; or (b) as calculated&#xD;
      by the research team during the Screening Visit (see the &quot;Subject Diary&quot;). The Lumosity&#xD;
      software allows for monitoring of participant compliance by researchers. Patients in the&#xD;
      control group will carry out their normal activities prior to surgery.&#xD;
&#xD;
      All patients will undergo surgery as planned. On the day of surgery, prior to proceeding to&#xD;
      the operating room, patients will be assessed with the Confusion Assessment Method (CAM) to&#xD;
      confirm no presence of delirium pre-operatively. In the Post-anesthesia Recovery Unit, a&#xD;
      different member of the research team (blinded to the patient's group assignment) will repeat&#xD;
      the CAM to assess for PD. While hospitalized, pain scores determined using the Verbal Analog&#xD;
      Scale and narcotic use will be obtained from the electronic medical record with at least 8&#xD;
      hour frequency (entered by registered nurses). All participants will be evaluated by a&#xD;
      blinded researcher using the combined CAM/Memorial Delirium Assessment Scale (MDAS) at 7:30AM&#xD;
      ± 1.5 hrs and 6:30PM ± 1.5 hrs for PD on subsequent post-op days until discharge.&#xD;
      Additionally, the PQRS will be completed at each 6:30PM ± 1.5 hrs assessment. The PQRS, MMSE,&#xD;
      and SAGE will be repeated just prior to discharge or on POD 7. A different form for the SAGE&#xD;
      examination, as well as alternate number and word sequences for the PQRS and MMSE&#xD;
      assessments, will be used in order to reduce the potential influence of the learning effect.&#xD;
      At the end of this visit, active patient participation is complete. For subjects discharged&#xD;
      before POD 7, the PQRS will be given again via telephone. Follow-up visits will be conducted&#xD;
      on POD 30 and POD 90 via telephone. The PQRS will be obtained on POD 30, and the PQRS, GDS,&#xD;
      and SF-36 will be obtained on POD 90. The research team will also periodically check the&#xD;
      medical record during this time for readmissions and provider notes related to medical&#xD;
      events. Participation is complete after POD 90.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the incidence of Post-Operative Delirium (%)</measure>
    <time_frame>Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first)</time_frame>
    <description>Assuming a 30% incidence of PD and proposed 50% reduction of PD in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I error rate. Assuming approximately 1/3 of consented patients either fail screening or do not complete the study after consent, we expect to consent 358 patients. The incidence of PD will be compared between the control group and the intervention group as detected by the Confusion Assessment Method (CAM) / Memorial Delirium Assessment Scale (MDAS). Once a patient is positive, they will no longer be assessed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">322</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The cognitive exercises will consist of a series of computer games focusing on five categories: memory, speed, attention, flexibility and problem-solving. Participants will be expected to complete 1 hour of Lumosity exercise daily for a minimum of 8 days prior to surgery. Participants will be instructed to complete no less than 15 minutes of exercise at a time throughout each day. Each hour of exercise, participants will work through at least 1 game under each category. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Activity</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized into the Normal Activity group will be encouraged to maintain their normal activity level prior to surgery. These participants are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and not permitted to subscribe to Lumosity while in the research study. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mini-Mental State Examination</intervention_name>
    <description>To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>MMSE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-Administered Gerocognitive Examination</intervention_name>
    <description>To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>SAGE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Geriatric Depression Scale</intervention_name>
    <description>To be completed at the Screening Visit and at POD 90</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>GDS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Charlson Comorbidity Index</intervention_name>
    <description>To be completed at the Screening Visit and at POD 90</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>CCI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short Form 36 Health Survey</intervention_name>
    <description>To be completed at the Screening Visit</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>SF-36</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Confusion Assessment Method</intervention_name>
    <description>To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>CAM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Memorial Delirium Assessment Scale</intervention_name>
    <description>To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>MDAS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postoperative Quality of Recovery Scale</intervention_name>
    <description>To be completed at Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 6:30PM ± 1.5 hrs (or until hospital discharge). Will be completed POD 7 over the phone if patient already discharged. Will be completed on POD 30 and POD 90.</description>
    <arm_group_label>Cognitive Exercise</arm_group_label>
    <arm_group_label>Normal Activity</arm_group_label>
    <other_name>PQRS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. 60 years of age or older&#xD;
&#xD;
          2. Capable and willing to consent&#xD;
&#xD;
          3. Non-cardiac/non-neurological surgery with expected hospital stay of at least 72 H&#xD;
&#xD;
          4. American Society of Anesthesiologists (ASA) physical status I-IV&#xD;
&#xD;
          5. English speaking&#xD;
&#xD;
          6. Willingness to use a provided tablet device&#xD;
&#xD;
          7. Willingness to commit at least 1 hour per day to experimental intervention (cognitive&#xD;
             activity/exercise) to complete a minimum of 10 hours within at least 8 days prior to&#xD;
             surgery.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Severe visual or auditory deficits&#xD;
&#xD;
          2. Illiterate&#xD;
&#xD;
          3. Surgery within the previous 6 months requiring general anesthesia&#xD;
&#xD;
          4. Score &lt; 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for&#xD;
             patients with less than high school education)&#xD;
&#xD;
          5. Positive pre-surgery Confusion Assessment Method test (CAM)&#xD;
&#xD;
          6. Active depression as indicated by Geriatric Depression Scale screening test (score ≥&#xD;
             10)&#xD;
&#xD;
          7. History of Axis I or II psychiatric disorders including bipolar disorder,&#xD;
             schizophrenia, dementia, alcohol or drug abuse&#xD;
&#xD;
          8. ASA physical status V, VI&#xD;
&#xD;
          9. Planned postoperative intubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle L Humeidan, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ohio State University Wexner Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Michelle Humeidan</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Delirium</keyword>
  <keyword>Post Operative Delirium</keyword>
  <keyword>PD</keyword>
  <keyword>POD</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Anesthesiology</keyword>
  <keyword>Post Operative Recovery</keyword>
  <keyword>Post Anesthesia Care Unit</keyword>
  <keyword>PACU</keyword>
  <keyword>Cognition</keyword>
  <keyword>Cognitive Impairment</keyword>
  <keyword>Memory</keyword>
  <keyword>Thinking</keyword>
  <keyword>Confusion Assessment Method</keyword>
  <keyword>CAM</keyword>
  <keyword>Neurobics</keyword>
  <keyword>Neuroplasticity</keyword>
  <keyword>Lumosity</keyword>
  <keyword>Brain Games</keyword>
  <keyword>Cognitive Exercise</keyword>
  <keyword>Cognitive Training</keyword>
  <keyword>Perioperative Cognitive Protection</keyword>
  <keyword>Cognitive Reserve</keyword>
  <keyword>Neurobics Trial</keyword>
  <keyword>Surgery</keyword>
  <keyword>Elderly Patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02230605
org study id: 2013H0388
nct id: NCT02230605
lead sponsor: 
has dmc: No
Many individuals experience an acute change in thinking and reasoning skills after surgery.
      This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after
      surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study
      is to determine if performing mental exercise, before surgery, will help reduce post-surgery
      memory and thinking problems. Assuming a 30% incidence of PD and proposed 50% reduction of PD
      in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each
      group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I
      error rate. Assuming approximately 1/3 of consented patients either fail screening or do not
      complete the study after consent, we expect to consent 358 patients.

      At least 8 days before surgery, subjects complete a series of questionnaires to assess
      baseline cognition level (or thinking ability) and status of overall well-being. At the
      completion of the screening visit, qualifying subjects are randomized into two groups:

      Participants randomized into the Cognitive Exercise group are expected to complete
      tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for
      the duration of the preoperative period. Participants in this group are expected to complete
      a minimum of 10 hours within at least 8 days prior to surgery.

      Participants randomized into the Normal Activity group are encouraged to carry out their
      baseline daily activities, and do not have any study-related cognitive exercise expectations
      before surgery. These subjects still complete the same questionnaires and assessments as the
      Cognitive Exercise group throughout the study, however, are asked not to alter their normal
      daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are
      not permitted to subscribe to Lumosity while in the research study.

      On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is
      taken before surgery. During surgery, research personnel monitor vital signs and medications
      given. After surgery, another CAM evaluation is taken in the post-operative recovery room.

      Throughout the subject's hospital stay, pain levels and medication usage are recorded. The
      CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity
      of PD. The evaluations are given twice daily, at at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs,
      for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of
      Recovery Scale (PQRS) is used each post-operative day at 6:30PM ± 1.5 hrs until discharge,
      and completed over the phone on POD 7 if patient discharged. The PQRS is also administered
      over the phone on POD 30 and POD 90.
Potential study participants will be identified one of two ways, either by the treating
      physician in clinic when the decision is made to pursue surgery or by researchers monitoring
      the OR schedule. When a potential participant is identified by the treating physician in
      clinic, they will ask the patient if study personnel may call them to discuss the study. If
      the patient agrees to be contacted, the surgeon will alert study personnel who will call the
      patient to explain the study and arrange the initial study (screening) visit. Study personnel
      will monitor the OR schedule and call any potential patients the surgeons have not already
      identified in clinic. In this case, patients will be informed over the phone that their
      surgeon has granted permission to contact them regarding the study. Surgeons will be made
      aware when their patients have been approached over the phone, and updated accordingly if the
      patient agrees to the screening visit and is subsequently enrolled in the study. All
      screening visits will occur at the OSU Pre-operative Assessment Center (OPAC). When possible
      the screening visit will co-inside with pre-operative testing per the Anesthesia Department
      at OPAC.

      Informed consent will occur at the initial screening visit which is to take place
      approximately 2 weeks prior to surgery, but no less than 8 days pre-op. At this visit, a
      member of the research team will obtain demographic information (gender, education level),
      historical medical information, and information regarding medication usage. The researcher
      will perform the Mini-Mental Status Exam (MMSE) - the modified version (see attached
      document), Self Administered Gerocognitve Form (SAGE) - all four versions (see attached
      questionnaires), Geriatric Depression Scale, Charlson Comorbidity Index, Postoperative
      Quality Recovery Scale (PQRS), and Short-form 36 Health Related Quality of Life Measure.
      Patients meeting inclusion criteria will be randomized to either the cognitive exercise or
      control group. Patients in the cognitive exercise group will be given a tablet with
      preinstalled access to Lumosity (Lumos Labs, San Francisco, CA, USA), a cognitive exercise
      software application which will be used in this study. Each participant in the cognitive
      exercise group will be expected to complete 1 hour of Lumosity brain exercise daily for a
      minimum of 8 days prior to surgery, equaling an effective 'dose' at least 10 hours. Playing
      time will be determined either by: (a) the actual in-game playing time; or (b) as calculated
      by the research team during the Screening Visit (see the "Subject Diary"). The Lumosity
      software allows for monitoring of participant compliance by researchers. Patients in the
      control group will carry out their normal activities prior to surgery.

      All patients will undergo surgery as planned. On the day of surgery, prior to proceeding to
      the operating room, patients will be assessed with the Confusion Assessment Method (CAM) to
      confirm no presence of delirium pre-operatively. In the Post-anesthesia Recovery Unit, a
      different member of the research team (blinded to the patient's group assignment) will repeat
      the CAM to assess for PD. While hospitalized, pain scores determined using the Verbal Analog
      Scale and narcotic use will be obtained from the electronic medical record with at least 8
      hour frequency (entered by registered nurses). All participants will be evaluated by a
      blinded researcher using the combined CAM/Memorial Delirium Assessment Scale (MDAS) at 7:30AM
      ± 1.5 hrs and 6:30PM ± 1.5 hrs for PD on subsequent post-op days until discharge.
      Additionally, the PQRS will be completed at each 6:30PM ± 1.5 hrs assessment. The PQRS, MMSE,
      and SAGE will be repeated just prior to discharge or on POD 7. A different form for the SAGE
      examination, as well as alternate number and word sequences for the PQRS and MMSE
      assessments, will be used in order to reduce the potential influence of the learning effect.
      At the end of this visit, active patient participation is complete. For subjects discharged
      before POD 7, the PQRS will be given again via telephone. Follow-up visits will be conducted
      on POD 30 and POD 90 via telephone. The PQRS will be obtained on POD 30, and the PQRS, GDS,
      and SF-36 will be obtained on POD 90. The research team will also periodically check the
      medical record during this time for readmissions and provider notes related to medical
      events. Participation is complete after POD 90.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Reduction in the incidence of Post-Operative Delirium (%)
time frame: Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first)
description: Assuming a 30% incidence of PD and proposed 50% reduction of PD in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I error rate. Assuming approximately 1/3 of consented patients either fail screening or do not complete the study after consent, we expect to consent 358 patients. The incidence of PD will be compared between the control group and the intervention group as detected by the Confusion Assessment Method (CAM) / Memorial Delirium Assessment Scale (MDAS). Once a patient is positive, they will no longer be assessed.
arm group label: Cognitive Exercise
arm group type: Experimental
description: The cognitive exercises will consist of a series of computer games focusing on five categories: memory, speed, attention, flexibility and problem-solving. Participants will be expected to complete 1 hour of Lumosity exercise daily for a minimum of 8 days prior to surgery. Participants will be instructed to complete no less than 15 minutes of exercise at a time throughout each day. Each hour of exercise, participants will work through at least 1 game under each category. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale.
arm group label: Normal Activity
arm group type: Placebo Comparator
description: Participants randomized into the Normal Activity group will be encouraged to maintain their normal activity level prior to surgery. These participants are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and not permitted to subscribe to Lumosity while in the research study. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale.
intervention type: Other
intervention name: Mini-Mental State Examination
description: To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: MMSE
intervention type: Other
intervention name: Self-Administered Gerocognitive Examination
description: To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: SAGE
intervention type: Other
intervention name: Geriatric Depression Scale
description: To be completed at the Screening Visit and at POD 90
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: GDS
intervention type: Other
intervention name: Charlson Comorbidity Index
description: To be completed at the Screening Visit and at POD 90
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: CCI
intervention type: Other
intervention name: Short Form 36 Health Survey
description: To be completed at the Screening Visit
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: SF-36
intervention type: Other
intervention name: Confusion Assessment Method
description: To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: CAM
intervention type: Other
intervention name: Memorial Delirium Assessment Scale
description: To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: MDAS
intervention type: Other
intervention name: Postoperative Quality of Recovery Scale
description: To be completed at Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 6:30PM ± 1.5 hrs (or until hospital discharge). Will be completed POD 7 over the phone if patient already discharged. Will be completed on POD 30 and POD 90.
arm group label: Cognitive Exercise
arm group label: Normal Activity
other name: PQRS
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michelle L Humeidan, MD,PhD
role: Principal Investigator
affiliation: The Ohio State University Wexner Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Michelle Humeidan
investigator title: Assistant Professor of Clinical Anesthesiology
mesh term: Delirium
sharing ipd: No