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Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2015 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Pressure ulcers are a common and severe complication of spinal cord injury, particularly in low-income and middle-income countries where people often need to manage pressure ulcers alone and at home. Telephone-based support may help people in these situations to manage their pressure ulcers. The aim of this study is to determine the effectiveness and cost-effectiveness of telephone-based support to help people with spinal cord injury manage pressure ulcers at home in India and Bangladesh.

Methods and analysis

A multicentre (3 sites), prospective, assessor-blinded, parallel, randomised controlled trial will be undertaken. 120 participants with pressure ulcers on the sacrum, ischial tuberosity or greater trochanter of the femur secondary to spinal cord injury will be randomly assigned to a Control or Intervention group. Participants in the Control group will receive usual community care. That is, they will manage their pressure ulcers on their own at home but will be free to access whatever healthcare support they can. Participants in the Intervention group will also manage their pressure ulcers at home and will also be free to access whatever healthcare support they can, but in addition they will receive weekly telephone-based support and advice for 12 weeks (15–25 min/week). The primary outcome is the size of the pressure ulcer at 12 weeks. 13 secondary outcomes will be measured reflecting other aspects of pressure ulcer resolution, depression, quality of life, participation and satisfaction with healthcare provision. An economic evaluation will be run in parallel and will include a cost-effectiveness and a cost-utility analysis.

Ethics and dissemination

Ethical approval was obtained from the Institutional Ethics Committee at each site. The results of this study will be disseminated through publications and presented at national and international conferences.

Trial registration number

ACTRN12613001225707.

Details

Title
Effectiveness and cost-effectiveness of telephone-based support versus usual care for treatment of pressure ulcers in people with spinal cord injury in low-income and middle-income countries: study protocol for a 12-week randomised controlled trial
Author
Arora, Mohit 1 ; Harvey, Lisa Anne 2 ; Hayes, Alison Joy 3 ; Harvinder Singh Chhabra 4 ; Glinsky, Joanne Valentina 2 ; Cameron, Ian Douglas 2 ; Lavrencic, Lucija 5 ; Arumugam, Narkeesh 6 ; Hossain, Sohrab 7 ; Bedi, Parneet Kaur 6 

 John Walsh Centre for Rehabilitation Research, Kolling Institute of Medical Research, Royal North Shore Hospital, Sydney Medical School Northern, The University of Sydney, St Leonards, New South Wales, Australia; Department of Spine Service, Indian Spinal Injuries Centre, Delhi, India 
 John Walsh Centre for Rehabilitation Research, Kolling Institute of Medical Research, Royal North Shore Hospital, Sydney Medical School Northern, The University of Sydney, St Leonards, New South Wales, Australia 
 School of Public Health, The University of Sydney, Sydney, New South Wales, Australia 
 Department of Spine Service, Indian Spinal Injuries Centre, Delhi, India 
 Spinal Cord Injury Unit, Royal North Shore Hospital, St Leonards, New South Wales, Australia 
 Department of Physiotherapy, Punjabi University, Patiala, Punjab, India 
 Centre for Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh 
First page
e008369
Section
Neurology
Publication year
2015
Publication date
2015
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
1860803696
Copyright
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2015 This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.