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The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04426071
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
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.

Condition or disease
Brain Injuries Stroke Spinal Cord Injuries

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
SCI, brain injury, stroke Participants
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.



Primary Outcome Measures :
  1. Change in Fear of COVID-19 [ Time Frame: baseline, 3 months, 6 months ]
    Fear of COVID-19 Questionnaire


Secondary Outcome Measures :
  1. Change in ability to participate in social roles and activities [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Ability to Part. in SRA

  2. Change in depressive symptoms [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Depression

  3. Change in positive affect and well-being [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Pos. Affect & Well-Being

  4. Change in anxiety [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Anxiety

  5. Change in fatigue [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Fatigue

  6. Change in emotional and behavioural dyscontrol [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol

  7. Change in satisfaction with social roles and activities [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Satisfaction w SRA

  8. Change in sleep disturbance [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Sleep Disturbance

  9. Change in stigma [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Stigma

  10. Change in cognitive function [ Time Frame: baseline, 3 months, 6 months ]
    NeuroQol SF v1.0 - Cognitive Function

  11. Change in social distancing strategies used [ Time Frame: baseline, 3 months, 6 months ]
    23 questions about strategies to social distance

  12. Change in thoughts and feelings about social distancing [ Time Frame: baseline, 3 months, 6 months ]
    22 questions about social distancing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those 18 years of age and older with 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.
Criteria

Inclusion Criteria:

  • stroke, spinal cord injury (traumatic and non-traumatic) or acquired brain injury (of all severities, including concussion)
  • live in the community
  • have the cognitive capacity to understand and complete the measures

Exclusion Criteria:

  • does not have the cognitive capacity to understand and complete the measures
  • does not speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426071


Contacts
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Contact: Eldon Loh, MD 5196854292 Eldon.Loh@sjhc.london.on.ca
Contact: Swati Mehta, PhD 5196854292 Swati.Mehta@sjhc.london.on.ca

Locations
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Canada, Ontario
Lawson Health Research Institute
London, Ontario, Canada, N6C2R5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Eldon Loh, MD St. Joseph's Health Care London
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04426071    
Other Study ID Numbers: 115999
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Stroke
Spinal Cord Injury
Brain Injury
COVID
Access to health care
Mental Health
Additional relevant MeSH terms:
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Brain Injuries
Spinal Cord Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases