Neuroscience Research Australia (NeuRA) and University of New South Wales, Sydney, Australia.
John Walsh Centre for Rehabilitation Research, Sydney Medical School, The University of Sydney, Sydney, Australia.
Trials. 2019 Apr 25;20(1):238. doi: 10.1186/s13063-019-3181-2.
People who sustain spinal cord injuries in low- and middle-income countries are vulnerable to life-threatening complications after discharge. The aim of this trial is to determine the effect on all-cause mortality of a sustainable model of community-based care provided over the first 2 years after discharge.
The CIVIC trial is a single centre, parallel group trial with concealed and stratified randomisation. The protocol has been previously published (BMJ Open 2016;6:e010350). This paper provides the accompanying detailed statistical plan. In total, 410 people with recent spinal cord injury who are wheelchair dependent and about to be discharged from the Centre for the Rehabilitation of the Paralysed in Bangladesh are randomised to intervention or control groups. Participants assigned to the intervention group receive a model of community-based care in which a case manager provides ongoing telephone-based support and visits participants in their homes over a 2-year period. Participants assigned to the control group receive usual care which may involve a follow-up phone call or a home visit. The primary outcome is all-cause mortality at 2 years as determined by a blinded assessor (Bangladesh does not have a death registry). The primary effectiveness analysis will compare Kaplan-Meier survival curves (time from allocation to death) in the intervention and control groups using the log-rank test (two-tailed α = 0.05). Participants will be censored at the time they were last known to be alive or at the time of the follow-up assessment. Recruitment finished in March 2018 and the last assessment will be conducted in March 2020.
The CIVIC trial will provide unbiased and precise estimates of the effectiveness of a model of community-based care for people with spinal cord injuries in Bangladesh. The results will have implications for provision of health services for people with spinal cord injuries and other conditions that cause serious disability in low-income and middle-income countries.
ANZCTR, ACTRN12615000630516, U1111-1171-1876. Registered on 17 June 2015.
在中低收入国家，脊髓损伤患者出院后容易出现危及生命的并发症。本试验旨在确定在出院后 2 年内提供基于社区的可持续护理模式对全因死亡率的影响。
CIVIC 试验是一项单中心、平行组试验，采用隐蔽和分层随机化。该方案已于 2016 年在《英国医学杂志开放》上发表（BMJ Open 2016;6:e010350）。本文提供了配套的详细统计计划。共有 410 名近期脊髓损伤且即将从孟加拉国瘫痪康复中心出院的轮椅依赖患者被随机分配到干预组或对照组。分配到干预组的参与者接受基于社区的护理模式，其中一名个案经理通过电话提供持续支持，并在 2 年内对参与者的家庭进行家访。分配到对照组的参与者接受常规护理，其中可能包括随访电话或家访。主要结局是由盲法评估者确定的 2 年时全因死亡率（孟加拉国没有死亡登记）。主要有效性分析将使用对数秩检验（双侧 α=0.05）比较干预组和对照组的 Kaplan-Meier 生存曲线（从分配到死亡的时间）。参与者将在最后一次已知存活或随访评估时被删失。招募工作于 2018 年 3 月完成，最后一次评估将于 2020 年 3 月进行。
CIVIC 试验将为孟加拉国脊髓损伤患者提供基于社区的护理模式的有效性提供无偏且精确的估计。结果将对中低收入国家脊髓损伤患者和其他导致严重残疾的疾病的卫生服务提供产生影响。
澳大利亚新西兰临床试验注册中心，ACTRN12615000630516，U1111-1171-1876。于 2015 年 6 月 17 日注册。
