Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial

Research output: Contribution to journalJournal articleResearchpeer-review

  • Mohammad S Hossain
  • Lisa A Harvey
  • Md Akhlasur Rahman
  • Stephen Muldoon
  • Jocelyn L Bowden
  • Md Shofiqul Islam
  • Stephen Jan
  • Valerie Taylor
  • Ian D Cameron
  • Harvinder Singh Chhabra
  • Richard I Lindley
  • Biering-Sørensen, Fin
  • Qiang Li
  • Murali Dhakshinamurthy
  • Robert D Herbert

INTRODUCTION: 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 AND ANALYSIS: 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.

ETHICS AND DISSEMINATION: 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.

TRIAL REGISTRATION NUMBERS: ACTRN12615000630516, U1111-1171-1876.

Original languageEnglish
Article numbere010350
JournalB M J Open
Volume6
Issue number1
Number of pages8
ISSN2044-6055
DOIs
Publication statusPublished - 2016

    Research areas

  • Adolescent, Adult, Aged, Bangladesh, Clinical Protocols, Community Health Services, Cost of Illness, Cost-Benefit Analysis, Disabled Persons, Female, House Calls, Humans, Male, Middle Aged, Paraplegia, Patient Education as Topic, Quadriplegia, Spinal Cord Injuries, Treatment Outcome, Wheelchairs, Young Adult, Journal Article, Pragmatic Clinical Trial, Randomized Controlled Trial

ID: 172392522