Community-based interventions to prevent serious complications following spinal cord injury in Bangladesh: the CIVIC trial statistical analysis plan

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.