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

Completed

• Conditions: Stroke; Spinal Cord Injuries; Brain Injuries

• Registration Number: NCT04426071
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-05-28
• Study Start: 2020-06-01
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Fear of COVID-19	baseline, 3 months, 6 months	Fear of COVID-19 Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada