<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/NCT04426071</url>
  </required_header>
  <id_info>
    <org_study_id>115999</org_study_id>
    <nct_id>NCT04426071</nct_id>
  </id_info>
  <brief_title>The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries</brief_title>
  <official_title>COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and&#xD;
      ABI-related disability and functional impairments, and the resultant effects on psychological&#xD;
      wellbeing, physical wellbeing and quality of life for those with SCI/ABI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a longitudinal survey to examine the impact of COVID19 on&#xD;
      those with SCI and ABI. An a priori sample size of 117 individuals based on an alpha level of&#xD;
      .05 and level of acceptable error at 3% was calculated. Anticipating for loss to follow up&#xD;
      rate of up to 20%, a total of 142 participants will be recruited. Patients will be recruited&#xD;
      among those who attend virtual medical appointments at Parkwood Institute for ABI and SCI. We&#xD;
      will also liaise with SCI-Ontario and the Ontario Brain Injury Association to assist in the&#xD;
      recruitment of additional participants. Those who consent will complete an online survey on&#xD;
      enrollment into the study, and subsequently at 3 and 6 months. Demographic data of the&#xD;
      individuals participating in the study will be recorded. Participants' access to health care&#xD;
      services will be evaluated using the following subdomains: medical care, complementary care,&#xD;
      medications/equipment, satisfaction/acceptability, affordability, ability to engage, and&#xD;
      indirect support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Change in Fear of COVID-19</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>Fear of COVID-19 Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ability to participate in social roles and activities</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Ability to Part. in SRA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptoms</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in positive affect and well-being</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Pos. Affect &amp; Well-Being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emotional and behavioural dyscontrol</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Emotional &amp; Beh. Dyscontrol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in satisfaction with social roles and activities</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Satisfaction w SRA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep disturbance</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Sleep Disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stigma</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Stigma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>NeuroQol SF v1.0 - Cognitive Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social distancing strategies used</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>23 questions about strategies to social distance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in thoughts and feelings about social distancing</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>22 questions about social distancing</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Brain Injuries</condition>
  <condition>Stroke</condition>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>SCI, brain injury, stroke Participants</arm_group_label>
    <description>Those 18 years of age and older, diagnosed with a stroke, spinal cord injury (traumatic and non-traumatic), or acquired brain injury (of all severities, including concussion) living in the community will be included. Additionally, only those the cognitive capacity to understand and complete the measures will be included. Those who consent will complete an online survey on enrollment into the study, and subsequently at 3 and 6 months.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Those 18 years of age and older with stroke, spinal cord injury (traumatic and&#xD;
        non-traumatic) or acquired brain injury (of all severities, including concussion) living in&#xD;
        the community will be included. Additionally, only those the cognitive capacity to&#xD;
        understand and complete the measures will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke, spinal cord injury (traumatic and non-traumatic) or acquired brain injury (of&#xD;
             all severities, including concussion)&#xD;
&#xD;
          -  live in the community&#xD;
&#xD;
          -  have the cognitive capacity to understand and complete the measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  does not have the cognitive capacity to understand and complete the measures&#xD;
&#xD;
          -  does not speak English&#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>Eldon Loh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Health Care London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lawson Health Research Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C2R5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 18, 2022</last_update_submitted>
  <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Spinal Cord Injury</keyword>
  <keyword>Brain Injury</keyword>
  <keyword>COVID</keyword>
  <keyword>Access to health care</keyword>
  <keyword>Mental Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT04426071
org study id: 115999
nct id: NCT04426071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and
      ABI-related disability and functional impairments, and the resultant effects on psychological
      wellbeing, physical wellbeing and quality of life for those with SCI/ABI.
The investigators will conduct a longitudinal survey to examine the impact of COVID19 on
      those with SCI and ABI. An a priori sample size of 117 individuals based on an alpha level of
      .05 and level of acceptable error at 3% was calculated. Anticipating for loss to follow up
      rate of up to 20%, a total of 142 participants will be recruited. Patients will be recruited
      among those who attend virtual medical appointments at Parkwood Institute for ABI and SCI. We
      will also liaise with SCI-Ontario and the Ontario Brain Injury Association to assist in the
      recruitment of additional participants. Those who consent will complete an online survey on
      enrollment into the study, and subsequently at 3 and 6 months. Demographic data of the
      individuals participating in the study will be recorded. Participants' access to health care
      services will be evaluated using the following subdomains: medical care, complementary care,
      medications/equipment, satisfaction/acceptability, affordability, ability to engage, and
      indirect support.
observational model: Cohort
time perspective: Prospective
measure: Change in Fear of COVID-19
time frame: baseline, 3 months, 6 months
description: Fear of COVID-19 Questionnaire
measure: Change in ability to participate in social roles and activities
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Ability to Part. in SRA
measure: Change in depressive symptoms
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Depression
measure: Change in positive affect and well-being
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Pos. Affect & Well-Being
measure: Change in anxiety
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Anxiety
measure: Change in fatigue
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Fatigue
measure: Change in emotional and behavioural dyscontrol
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol
measure: Change in satisfaction with social roles and activities
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Satisfaction w SRA
measure: Change in sleep disturbance
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Sleep Disturbance
measure: Change in stigma
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Stigma
measure: Change in cognitive function
time frame: baseline, 3 months, 6 months
description: NeuroQol SF v1.0 - Cognitive Function
measure: Change in social distancing strategies used
time frame: baseline, 3 months, 6 months
description: 23 questions about strategies to social distance
measure: Change in thoughts and feelings about social distancing
time frame: baseline, 3 months, 6 months
description: 22 questions about social distancing
arm group label: SCI, brain injury, stroke Participants
description: Those 18 years of age and older, diagnosed with a stroke, spinal cord injury (traumatic and non-traumatic), or acquired brain injury (of all severities, including concussion) living in the community will be included. Additionally, only those the cognitive capacity to understand and complete the measures will be included. Those who consent will complete an online survey on enrollment into the study, and subsequently at 3 and 6 months.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eldon Loh, MD
role: Principal Investigator
affiliation: St. Joseph's Health Care London
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries