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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Brain Injuries; 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.

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C2R5
      • Lawson Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fear of COVID-19	Fear of COVID-19 Questionnaire	baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ability to participate in social roles and activities	NeuroQol SF v1.0 - Ability to Part. in SRA	baseline, 3 months, 6 months
Change in depressive symptoms	NeuroQol SF v1.0 - Depression	baseline, 3 months, 6 months
Change in positive affect and well-being	NeuroQol SF v1.0 - Pos. Affect & Well-Being	baseline, 3 months, 6 months
Change in anxiety	NeuroQol SF v1.0 - Anxiety	baseline, 3 months, 6 months
Change in fatigue	NeuroQol SF v1.0 - Fatigue	baseline, 3 months, 6 months
Change in emotional and behavioural dyscontrol	NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol	baseline, 3 months, 6 months
Change in satisfaction with social roles and activities	NeuroQol SF v1.0 - Satisfaction w SRA	baseline, 3 months, 6 months
Change in sleep disturbance	NeuroQol SF v1.0 - Sleep Disturbance	baseline, 3 months, 6 months
Change in stigma	NeuroQol SF v1.0 - Stigma	baseline, 3 months, 6 months
Change in cognitive function	NeuroQol SF v1.0 - Cognitive Function	baseline, 3 months, 6 months
Change in social distancing strategies used	23 questions about strategies to social distance	baseline, 3 months, 6 months
Change in thoughts and feelings about social distancing	22 questions about social distancing	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Eldon Loh, MD, St. Joseph's Health Care London

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mental Health; Stroke; COVID; Spinal Cord Injury; Brain Injury; Access to health care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 115999

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No