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低收入和中等收入国家脊髓损伤患者压力性溃疡治疗中基于电话的支持与常规护理的有效性和成本效益:一项为期12周随机对照试验的研究方案

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.

作者信息

Arora Mohit, Harvey Lisa Anne, Hayes Alison Joy, Chhabra Harvinder Singh, Glinsky Joanne Valentina, Cameron Ian Douglas, Lavrencic Lucija, Arumugam Narkeesh, Hossain Sohrab, Bedi Parneet Kaur

机构信息

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.

出版信息

BMJ Open. 2015 Jul 28;5(7):e008369. doi: 10.1136/bmjopen-2015-008369.

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.

摘要

引言

压疮是脊髓损伤常见且严重的并发症,在低收入和中等收入国家尤为如此,这些国家的人们通常需要独自在家处理压疮问题。基于电话的支持可能有助于这些情况下的人们管理压疮。本研究的目的是确定基于电话的支持对帮助印度和孟加拉国脊髓损伤患者在家管理压疮的有效性和成本效益。

方法与分析

将进行一项多中心(3个地点)、前瞻性、评估者盲法、平行、随机对照试验。120名因脊髓损伤导致骶骨、坐骨结节或股骨大转子处出现压疮的参与者将被随机分配到对照组或干预组。对照组的参与者将接受常规社区护理。也就是说,他们将在家自行处理压疮,但可自由获取任何能得到的医疗支持。干预组的参与者也将在家处理压疮,同样可自由获取任何能得到的医疗支持,但除此之外,他们将在12周内(每周15 - 25分钟)接受每周一次的基于电话的支持和建议。主要结局是12周时压疮的大小。将测量13个次要结局,以反映压疮愈合、抑郁、生活质量、参与度以及对医疗服务满意度的其他方面。将同时进行经济评估,包括成本效益分析和成本效用分析。

伦理与传播

已获得各研究地点机构伦理委员会的伦理批准。本研究结果将通过发表论文进行传播,并在国内和国际会议上展示。

试验注册号

ACTRN12613001225707。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bfe4/4521536/4eaeff1b086d/bmjopen2015008369f01.jpg

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