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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426071
• Other study ID #: 115999
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Spinal Cord Injuries
• Stroke
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fear of COVID-19	Fear of COVID-19 Questionnaire	baseline, 3 months, 6 months
Secondary	Change in ability to participate in social roles and activities	NeuroQol SF v1.0 - Ability to Part. in SRA	baseline, 3 months, 6 months
Secondary	Change in depressive symptoms	NeuroQol SF v1.0 - Depression	baseline, 3 months, 6 months
Secondary	Change in positive affect and well-being	NeuroQol SF v1.0 - Pos. Affect & Well-Being	baseline, 3 months, 6 months
Secondary	Change in anxiety	NeuroQol SF v1.0 - Anxiety	baseline, 3 months, 6 months
Secondary	Change in fatigue	NeuroQol SF v1.0 - Fatigue	baseline, 3 months, 6 months
Secondary	Change in emotional and behavioural dyscontrol	NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol	baseline, 3 months, 6 months
Secondary	Change in satisfaction with social roles and activities	NeuroQol SF v1.0 - Satisfaction w SRA	baseline, 3 months, 6 months
Secondary	Change in sleep disturbance	NeuroQol SF v1.0 - Sleep Disturbance	baseline, 3 months, 6 months
Secondary	Change in stigma	NeuroQol SF v1.0 - Stigma	baseline, 3 months, 6 months
Secondary	Change in cognitive function	NeuroQol SF v1.0 - Cognitive Function	baseline, 3 months, 6 months
Secondary	Change in social distancing strategies used	23 questions about strategies to social distance	baseline, 3 months, 6 months
Secondary	Change in thoughts and feelings about social distancing	22 questions about social distancing	baseline, 3 months, 6 months