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Clinical Trials/NCT04426071
NCT04426071
Completed
Not Applicable

COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Lawson Health Research Institute1 site in 1 country142 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
Lawson Health Research Institute
Enrollment
142
Locations
1
Primary Endpoint
Change in Fear of COVID-19
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Fear of COVID-19

Time Frame: baseline, 3 months, 6 months

Fear of COVID-19 Questionnaire

Secondary Outcomes

  • Change in stigma(baseline, 3 months, 6 months)
  • Change in positive affect and well-being(baseline, 3 months, 6 months)
  • Change in emotional and behavioural dyscontrol(baseline, 3 months, 6 months)
  • Change in satisfaction with social roles and activities(baseline, 3 months, 6 months)
  • Change in sleep disturbance(baseline, 3 months, 6 months)
  • Change in ability to participate in social roles and activities(baseline, 3 months, 6 months)
  • Change in depressive symptoms(baseline, 3 months, 6 months)
  • Change in fatigue(baseline, 3 months, 6 months)
  • Change in cognitive function(baseline, 3 months, 6 months)
  • Change in social distancing strategies used(baseline, 3 months, 6 months)
  • Change in anxiety(baseline, 3 months, 6 months)
  • Change in thoughts and feelings about social distancing(baseline, 3 months, 6 months)

Study Sites (1)

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