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.
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.
复制标题
在低收入和中等收入国家中，基于电话的支持与治疗脊髓损伤患者压力溃疡的有效性和成本效益：为期12周的随机对照试验的研究方案。
DOI：
10.1136/bmjopen-2015-008369
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发表时间：
2015-07-28
期刊：
影响因子：
2.9
通讯作者：
Bedi PK
中科院分区：
文献类型：
--
作者：
Arora M;Harvey LA;Hayes AJ;Chhabra HS;Glinsky JV;Cameron ID;Lavrencic L;Arumugam N;Hossain S;Bedi PK
压疮是脊髓损伤的一种常见和严重并发症，特别是在低收入和中等收入国家，人们往往需要单独或在家中处理压疮。基于电话的支持可以帮助人们在这些情况下管理他们的压疮。本研究的目的是确定电话支持的有效性和成本效益，以帮助印度和孟加拉国的脊髓损伤患者在家中管理压疮。将进行一项多中心（3个地点）、前瞻性、评估盲、平行、随机对照试验。120名患有继发于脊髓损伤的骶骨、坐骨结节或股骨大转子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的社区护理。也就是说，他们将在家里自己治疗压疮，但可以自由地获得任何医疗支持。干预组的参与者也将在家中管理他们的压疮，也将免费获得他们可以获得的任何医疗保健支持，但除此之外，他们将每周接受基于电话的支持和建议，为期12周（15-25分钟/周）。主要结果是12周时压疮的大小。将测量13个次要结果，反映压疮缓解、抑郁、生活质量、参与和对医疗保健服务的满意度等其他方面。经济评价将同时进行，并将包括成本效益和成本效用分析。每个试验地点都获得了机构伦理委员会的伦理批准。这项研究的结果将通过出版物传播，并在国家和国际会议上提出。ACTRN12613001225707。
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. 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. 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. ACTRN12613001225707.