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

TY - JOUR

T1 - Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh

T2 - protocol of a randomised controlled trial

AU - Hossain, Mohammad S

AU - Harvey, Lisa A

AU - Rahman, Md Akhlasur

AU - Muldoon, Stephen

AU - Bowden, Jocelyn L

AU - Islam, Md Shofiqul

AU - Jan, Stephen

AU - Taylor, Valerie

AU - Cameron, Ian D

AU - Chhabra, Harvinder Singh

AU - Lindley, Richard I

AU - Biering-Sørensen, Fin

AU - Li, Qiang

AU - Dhakshinamurthy, Murali

AU - Herbert, Robert D

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016

Y1 - 2016

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.

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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Bangladesh

KW - Clinical Protocols

KW - Community Health Services

KW - Cost of Illness

KW - Cost-Benefit Analysis

KW - Disabled Persons

KW - Female

KW - House Calls

KW - Humans

KW - Male

KW - Middle Aged

KW - Paraplegia

KW - Patient Education as Topic

KW - Quadriplegia

KW - Spinal Cord Injuries

KW - Treatment Outcome

KW - Wheelchairs

KW - Young Adult

KW - Journal Article

KW - Pragmatic Clinical Trial

KW - Randomized Controlled Trial

U2 - 10.1136/bmjopen-2015-010350

DO - 10.1136/bmjopen-2015-010350

M3 - Journal article

C2 - 26743709

SN - 2044-6055

VL - 6

JO - BMJ Open

JF - BMJ Open

IS - 1

M1 - e010350

ER -