CIVIC trial: Community‐based InterVentions to prevent serious Complications following spinal cord injury in Bangladesh
The CIVIC trial started as a pilot study at the end of November 2013. The pilot study was funded by the University of Sydney, Australia, and a collaborative project between the Centre for the Rehabilitation of the Paralysed, University of Sydney and a team of academics and SCI professionals from around the world. The pilot study included 30 patients with spinal cord injury (SCI) who had been successfully discharged from Centre for the Rehabilitation of the Paralyzed (CRP). Patients were selected according to a pre-specified inclusion criteria and randomized into either usual care or a model of ongoing community-based care for 2 years post discharge. These 30 patients will have their final assessment in January/February 2016. However, even before the final results had been collected, this pilot study was successfully used to attain a grant from National Health and Medical Research Council of Australia to conduct a much larger study based on the pilot study. The larger study has a sample of 410 people and commenced in July 2015. It is being led by Associate Professor Mohammad Sohrab Hossain (from CRP), Professor Lisa Harvey (from The University of Sydney, Australia) and Professor Robert Herbert (from Neuroscience Research Australia, Australia) and has a team of other investigators from Bangladesh, Australia, India, Ireland and Denmark.
The Primary objective of the CIVIC trial is to determine whether a low‐cost community‐based model of care reduces all‐cause mortality for people with SCI in Bangladesh. The Secondary objectives are to determine whether this model of care reduces the burden of complications, reduces the prevalence and severity of pressure ulcers, reduces depression, enhances quality of life, independence and participation, and is cost‐effective.
The trial is expected to be take approximately five years to complete (July 2015 to June 2020), including two years for recruitment and a two-year follow up assessment for each participant. 410 patients with SCI from the Centre for the Rehabilitation of the Paralyzed (CRP) will be recruited at the time of discharge. Patients are eligible for inclusion if they are 15 years or older and are dependent on a wheelchair for mobility. Patients will be randomly allocated to either an Intervention or Control group.
Participants allocated to the Control Group will receive standard care. That is, they will continue to receive the same standard of care post discharge as is currently provided by the Centre for Rehabilitation of the Paralysed.
The primary outcome is mortality at two years. The secondary outcomes are burden of complications, prevalence and severity of pressure ulcers, depression, quality of life, independence and participation.
The trial is being conducted to international clinical trial standards (termed Good Clinical Practice, GCP) and is being managed by George Clinical India. There is an independent Data Monitoring Board and the trial is being managed at CRP by Md. Shofiqul Islam and Md. Akhlasur Rahman. The team of investigators include; Associate Professor Mohammad S Hossain, Professor Lisa A Harvey, Professor Robert D Herbert, Mr Stephen Muldoon, Professor Stephen Jan, Ms Valerie Taylor, Professor Ian D Cameron, Dr Harvinder Singh Chhabra, Professor Richard I Lindley, Professor Fin Biering-Sørensen and Dr Qiang Li.
Click here to see the full trial protocol. http://bmjopen.bmj.com/content/6/1/e010350.full
Click here to see the protocol of process evaluation of CIVIC. https://bmjopen.bmj.com/content/8/7/e024226
Clink here to see the CIVIC statistical plan. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3181-2