Brain InjuriesNCT04426071
The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries
An observational study of Brain Injuries and Stroke, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Stroke, Spinal Cord Injuries
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- does not have the cognitive capacity to understand and complete the measures
- does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injuries, Stroke, Spinal Cord Injuries
- Keywords
- Stroke, Spinal Cord Injury, Brain Injury, COVID, Access to health care, Mental Health
- Medical subject headings
- Brain Injuries, Stroke, Spinal Cord Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Fear of COVID-19
Fear of COVID-19 Questionnaire
Measured: baseline, 3 months, 6 months
Secondary outcomes (12)
Change in ability to participate in social roles and activities
NeuroQol SF v1.0 - Ability to Part. in SRA
Measured: baseline, 3 months, 6 months
Change in depressive symptoms
NeuroQol SF v1.0 - Depression
Measured: baseline, 3 months, 6 months
Change in positive affect and well-being
NeuroQol SF v1.0 - Pos. Affect \& Well-Being
Measured: baseline, 3 months, 6 months
Change in anxiety
NeuroQol SF v1.0 - Anxiety
Measured: baseline, 3 months, 6 months
Change in fatigue
NeuroQol SF v1.0 - Fatigue
Measured: baseline, 3 months, 6 months
Change in emotional and behavioural dyscontrol
NeuroQol SF v1.0 - Emotional \& Beh. Dyscontrol
Measured: baseline, 3 months, 6 months
Change in satisfaction with social roles and activities
NeuroQol SF v1.0 - Satisfaction w SRA
Measured: baseline, 3 months, 6 months
Change in sleep disturbance
NeuroQol SF v1.0 - Sleep Disturbance
Measured: baseline, 3 months, 6 months
Change in stigma
NeuroQol SF v1.0 - Stigma
Measured: baseline, 3 months, 6 months
Change in cognitive function
NeuroQol SF v1.0 - Cognitive Function
Measured: baseline, 3 months, 6 months
Change in social distancing strategies used
23 questions about strategies to social distance
Measured: baseline, 3 months, 6 months
Change in thoughts and feelings about social distancing
22 questions about social distancing
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eldon Loh, MD, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426071
- Sponsor's protocol ID
- 115999
- Status last verified
- Mar 2024
- First submitted
- 28 May 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries
- ClinicalTrials.gov ID
- NCT04426071
- Acronym / sponsor ID
- 115999
- Conditions
- Brain Injuries, Stroke, Spinal Cord Injuries
- Keywords
- Stroke, Spinal Cord Injury, Brain Injury, COVID, Access to health care, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- does not have the cognitive capacity to understand and complete the measures
- does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Fear of COVID-19
Time frame: baseline, 3 months, 6 months
Fear of COVID-19 Questionnaire
12 secondary outcomes
Change in ability to participate in social roles and activities
Time frame: baseline, 3 months, 6 months
Change in depressive symptoms
Time frame: baseline, 3 months, 6 months
Change in positive affect and well-being
Time frame: baseline, 3 months, 6 months
Change in anxiety
Time frame: baseline, 3 months, 6 months
Change in fatigue
Time frame: baseline, 3 months, 6 months
Change in emotional and behavioural dyscontrol
Time frame: baseline, 3 months, 6 months
Change in satisfaction with social roles and activities
Time frame: baseline, 3 months, 6 months
Change in sleep disturbance
Time frame: baseline, 3 months, 6 months
Change in stigma
Time frame: baseline, 3 months, 6 months
Change in cognitive function
Time frame: baseline, 3 months, 6 months
Change in social distancing strategies used
Time frame: baseline, 3 months, 6 months
Change in thoughts and feelings about social distancing
Time frame: baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eldon Loh, MD principal investigator
St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Stroke, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fear of COVID-19 (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.