TY - JOUR AU - Lindley R. AU - Bowden J. AU - Islam M. AU - Harvey L. AU - Cameron I. AU - Herbert R. AU - Li Q. AU - Hossain M. AU - Rahman M. AU - Muldoon S. AU - Taylor V. AU - Chhabra H. AU - Biering-Sorensen F. AU - Dhakshinamurthy M. AU - Jan Stephen AB -

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.

AD - Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
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.
Livability International, Enniskillen, Co Fermanagh N, Ireland.
George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
Indian Spinal Injuries Centre, New Delhi, India.
Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Hornbaek, Denmark.
George Clinical, The George Institute for Global Health, Bangalore, India.
Neuroscience Research Australia (NeuRA), Randwick, New South Wales, Australia. AN - 26743709 BT - BMJ Open DA - 93593937117 DP - NLM ET - 2016/01/09 LA - eng LB - FY16
AUS
OCS
PROF M1 - 1 N1 - Hossain, Mohammad S
Harvey, Lisa A
Rahman, Md Akhlasur
Muldoon, Stephen
Bowden, Jocelyn L
Islam, Md Shofiqul
Jan, Stephen
Taylor, Valerie
Cameron, Ian D
Chhabra, Harvinder Singh
Lindley, Richard I
Biering-Sorensen, Fin
Li, Qiang
Dhakshinamurthy, Murali
Herbert, Robert D
England
BMJ Open. 2016 Jan 7;6(1):e010350. doi: 10.1136/bmjopen-2015-010350. N2 -

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.

PY - 2016 SN - 2044-6055 (Electronic) EP - e010350 T2 - BMJ Open TI - Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial VL - 6 Y2 - FY16 ER -