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

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04426071
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries; Stroke; 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 Design

• Study Type: Observational
• Anticipated Enrollment: 142 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. Change in Fear of COVID-19 [baseline, 3 months, 6 months]

   Fear of COVID-19 Questionnaire

Secondary Outcome Measures

1. Change in ability to participate in social roles and activities [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Ability to Part. in SRA

2. Change in depressive symptoms [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Depression

3. Change in positive affect and well-being [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Pos. Affect & Well-Being

4. Change in anxiety [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Anxiety

5. Change in fatigue [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Fatigue

6. Change in emotional and behavioural dyscontrol [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol

7. Change in satisfaction with social roles and activities [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Satisfaction w SRA

8. Change in sleep disturbance [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Sleep Disturbance

9. Change in stigma [baseline, 3 months, 6 months]

   NeuroQol SF v1.0 - Stigma

10. Change in cognitive function [baseline, 3 months, 6 months]

    NeuroQol SF v1.0 - Cognitive Function

11. Change in social distancing strategies used [baseline, 3 months, 6 months]

    23 questions about strategies to social distance

12. Change in thoughts and feelings about social distancing [baseline, 3 months, 6 months]

    22 questions about social distancing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lawson Health Research Institute	London	Ontario	Canada	N6C2R5

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

• Principal Investigator: Eldon Loh, MD, St. Joseph's Health Care London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT04426071
• Other Study ID Numbers: 115999
• First Posted: Jun 11, 2020
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lawson Health Research Institute: Stroke; Spinal Cord Injury; Brain Injury; COVID; Access to health care; Mental Health
• Additional relevant MeSH terms: Brain Injuries; Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of May 20, 2022