Clinical trial NCT04426071: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries
Official title: COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Stroke
Spinal Cord Injuries
Keywords: Stroke
Spinal Cord Injury
Brain Injury
COVID
Access to health care
Mental Health
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Fear of COVID-19
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in ability to participate in social roles and activities
timeFrame: baseline, 3 months, 6 months
measure: Change in depressive symptoms
timeFrame: baseline, 3 months, 6 months
measure: Change in positive affect and well-being
timeFrame: baseline, 3 months, 6 months
measure: Change in anxiety
timeFrame: baseline, 3 months, 6 months
measure: Change in fatigue
timeFrame: baseline, 3 months, 6 months
measure: Change in emotional and behavioural dyscontrol
timeFrame: baseline, 3 months, 6 months
measure: Change in satisfaction with social roles and activities
timeFrame: baseline, 3 months, 6 months
measure: Change in sleep disturbance
timeFrame: baseline, 3 months, 6 months
measure: Change in stigma
timeFrame: baseline, 3 months, 6 months
measure: Change in cognitive function
timeFrame: baseline, 3 months, 6 months
measure: Change in social distancing strategies used
timeFrame: baseline, 3 months, 6 months
measure: Change in thoughts and feelings about social distancing
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Eldon Loh, MD
role: PRINCIPAL_INVESTIGATOR
References: