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Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial.
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-Sørensen, Fin; Li, Qiang; Dhakshinamurthy, Murali; Herbert, Robert D.
Afiliación
  • Hossain MS; Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
  • Harvey LA; 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.
  • Rahman MA; Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
  • Muldoon S; Livability International, Enniskillen, Co Fermanagh N, Ireland.
  • Bowden JL; 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.
  • Islam MS; Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
  • Jan S; George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
  • Taylor V; Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
  • Cameron ID; 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.
  • Chhabra HS; Indian Spinal Injuries Centre, New Delhi, India.
  • Lindley RI; George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
  • Biering-Sørensen F; Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Hornbæk, Denmark.
  • Li Q; George Institute for Global Health, University of Sydney, Camperdown, New South Wales, Australia.
  • Dhakshinamurthy M; George Clinical, The George Institute for Global Health, Bangalore, India.
  • Herbert RD; Neuroscience Research Australia (NeuRA), Randwick, New South Wales, Australia.
BMJ Open ; 6(1): e010350, 2016 Jan 07.
Article en En | MEDLINE | ID: mdl-26743709
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Servicios de Salud Comunitaria Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Aspecto: Ethics Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: BMJ Open Año: 2016 Tipo del documento: Article País de afiliación: Bangladesh Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Servicios de Salud Comunitaria Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Aspecto: Ethics Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: BMJ Open Año: 2016 Tipo del documento: Article País de afiliación: Bangladesh Pais de publicación: Reino Unido