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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ACTRN12613001225707.
authors.affiliation: 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.
authors.forename: Mohit
authors.initials: M
authors.lastname: Arora
authors.affiliation: 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.
authors.forename: Lisa Anne
authors.initials: LA
authors.lastname: Harvey
authors.affiliation: School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Alison Joy
authors.initials: AJ
authors.lastname: Hayes
authors.affiliation: Department of Spine Service, Indian Spinal Injuries Centre, Delhi, India.
authors.forename: Harvinder Singh
authors.initials: HS
authors.lastname: Chhabra
authors.affiliation: 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.
authors.forename: Joanne Valentina
authors.initials: JV
authors.lastname: Glinsky
authors.affiliation: 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.
authors.forename: Ian Douglas
authors.initials: ID
authors.lastname: Cameron
authors.affiliation: Spinal Cord Injury Unit, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
authors.forename: Lucija
authors.initials: L
authors.lastname: Lavrencic
authors.affiliation: Department of Physiotherapy, Punjabi University, Patiala, Punjab, India.
authors.forename: Narkeesh
authors.initials: N
authors.lastname: Arumugam
authors.affiliation: Centre for Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.
authors.forename: Sohrab
authors.initials: S
authors.lastname: Hossain
authors.affiliation: Department of Physiotherapy, Punjabi University, Patiala, Punjab, India.
authors.forename: Parneet Kaur
authors.initials: PK
authors.lastname: Bedi
mesh_terms: D001459:Bangladesh; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000379:methods*; D003906:Developing Countries; D017048:Health Care Costs; D006615:Hip; D006801:Humans; D007194:India; D008161:Lumbosacral Region; D017060:Patient Satisfaction; D003668:Pressure Ulcer / Q000209:etiology / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D012648:Self Care; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013119:Spinal Cord Injuries / Q000150:complications*; D013689:Telephone
keywords: HEALTH ECONOMICS; Telemedicine < BIOTECHNOLOGY & BIOINFORMATICS; WOUND MANAGEMENT