title: Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial.
abstract: BACKGROUND
  In low-income and middle-income countries, people with spinal cord injury (SCI) are vulnerable to life-threatening complications after they are discharged from hospital. The aim of this trial is to determine the effectiveness and cost-effectiveness of an inexpensive and sustainable model of community-based care designed to prevent and manage complications in people with SCI in Bangladesh.
  
  
  METHODS
  A pragmatic randomised controlled trial will be undertaken. 410 wheelchair-dependent people with recent SCI will be randomised to Intervention and Control groups shortly after discharge from hospital. Participants in the Intervention group will receive regular telephone-based care and three home visits from a health professional over the 2 years after discharge. Participants in the Control group will receive standard care, which does not involve regular contact with health professionals. The primary outcome is all-cause mortality at 2 years. Recruitment started on 12 July 2015 and the trial is expected to take 5 years to complete.
  
  
  BACKGROUND
  Ethical approval was obtained from the Institutional Ethics Committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95) and the Bangladesh Guidance on Clinical Trial Inspection (2011). The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.
  
  
  BACKGROUND
  ACTRN12615000630516, U1111-1171-1876.
authors.affiliation: Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
authors.forename: Mohammad S
authors.initials: MS
authors.lastname: Hossain
authors.affiliation: John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, c/o Royal North Shore Hospital, St Leonards, New South Wales, Australia.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Harvey
authors.affiliation: Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
authors.forename: Md Akhlasur
authors.initials: MA
authors.lastname: Rahman
authors.affiliation: Livability International, Enniskillen, Co Fermanagh N, Ireland.
authors.forename: Stephen
authors.initials: S
authors.lastname: Muldoon
authors.affiliation: John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, c/o Royal North Shore Hospital, St Leonards, New South Wales, Australia.
authors.forename: Jocelyn L
authors.identifier: http://orcid.org/0000-0002-0340-0232
authors.initials: JL
authors.lastname: Bowden
authors.affiliation: Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
authors.forename: Md Shofiqul
authors.initials: MS
authors.lastname: Islam
authors.affiliation: George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
authors.affiliation: Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
authors.forename: Valerie
authors.initials: V
authors.lastname: Taylor
authors.affiliation: John Walsh Centre for Rehabilitation Research, Kolling Institute, Sydney Medical School/Northern, University of Sydney, c/o Royal North Shore Hospital, St Leonards, New South Wales, Australia.
authors.forename: Ian D
authors.initials: ID
authors.lastname: Cameron
authors.affiliation: Indian Spinal Injuries Centre, New Delhi, India.
authors.forename: Harvinder Singh
authors.initials: HS
authors.lastname: Chhabra
authors.affiliation: George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Richard I
authors.initials: RI
authors.lastname: Lindley
authors.affiliation: Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Hornbæk, Denmark.
authors.forename: Fin
authors.initials: F
authors.lastname: Biering-Sørensen
authors.affiliation: George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: George Clinical, The George Institute for Global Health, Bangalore, India.
authors.forename: Murali
authors.initials: M
authors.lastname: Dhakshinamurthy
authors.affiliation: Neuroscience Research Australia (NeuRA), Randwick, New South Wales, Australia.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Herbert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001459:Bangladesh / Q000453:epidemiology; D002985:Clinical Protocols; D003153:Community Health Services / Q000191:economics / Q000458:organization & administration*; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D006233:Persons with Disabilities; D005260:Female; D006792:House Calls; D006801:Humans; D008297:Male; D008875:Middle Aged; D010264:Paraplegia / Q000150:complications / Q000191:economics / Q000401:mortality; D010353:Patient Education as Topic; D011782:Quadriplegia / Q000150:complications / Q000191:economics / Q000401:mortality; D013119:Spinal Cord Injuries / Q000150:complications* / Q000191:economics / Q000401:mortality; D016896:Treatment Outcome; D014910:Wheelchairs; D055815:Young Adult
keywords: spinal cord injury