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临床试验/NCT04426071
NCT04426071已完成不适用

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

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
1
主要终点
Change in Fear of COVID-19

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • does not have the cognitive capacity to understand and complete the measures
  • does not speak English

结局指标

主要结局

Change in Fear of COVID-19

时间窗: baseline, 3 months, 6 months

Fear of COVID-19 Questionnaire

次要结局

  • Change in stigma(baseline, 3 months, 6 months)
  • Change in positive affect and well-being(baseline, 3 months, 6 months)
  • Change in emotional and behavioural dyscontrol(baseline, 3 months, 6 months)
  • Change in satisfaction with social roles and activities(baseline, 3 months, 6 months)
  • Change in sleep disturbance(baseline, 3 months, 6 months)
  • Change in ability to participate in social roles and activities(baseline, 3 months, 6 months)
  • Change in depressive symptoms(baseline, 3 months, 6 months)
  • Change in fatigue(baseline, 3 months, 6 months)
  • Change in cognitive function(baseline, 3 months, 6 months)
  • Change in social distancing strategies used(baseline, 3 months, 6 months)
  • Change in anxiety(baseline, 3 months, 6 months)
  • Change in thoughts and feelings about social distancing(baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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