Ding Hang, Jayasena Rajiv, Maiorana Andrew, Dowling Alison, Chen Sheau Huey, Karunanithi Mohan, Layland Jamie, Edwards Iain
The Australian e-Health Research Centre, CSIRO, Brisbane, QLD, Australia.
The Australian e-Health Research Centre, CSIRO, Melbourne, VIC, Australia.
BMJ Open. 2017 Oct 8;7(10):e017550. doi: 10.1136/bmjopen-2017-017550.
Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients' compliance, and associated health and economic outcomes.
An open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.
The clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.
Registered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).
慢性心力衰竭（CHF）是一种危及生命的慢性疾病，其特征为周期性加重和反复住院。在慢性心力衰竭的管理中，患者遵循循证临床指南至关重要，但在实际操作中仍存在困难。本研究的目的是检验针对慢性心力衰竭的创新远程监测强化护理计划（ITEC-CHF）是否能提高患者的依从性以及相关的健康和经济结果。
已设计一项开放的多中心随机对照试验。将招募患者并随机分为两组，分别接受ITEC-CHF（n = 150）或慢性心力衰竭常规护理（n = 150），为期至少6个月。ITEC-CHF结合了常规护理和额外的远程监测服务，包括远程体重监测、结构化电话支持以及由护士主导的协作护理。主要结局是每日体重监测最佳实践指南的依从率。次要结局包括对其他指南建议（健康维护、药物治疗、饮食和运动）的依从性、健康状况（与健康相关的生活质量、危险因素、功能能力和心理状态）以及与使用医疗资源相关的经济结果，如再次住院和看全科医生/急诊就诊情况。
该临床试验已获得半岛健康人类研究伦理委员会（HREC编号：HREC/14/PH/27）、皇家珀斯医院人类研究伦理委员会（编号：15 - 081）以及科廷大学人类研究伦理委员会（编号：HR 181/2014）的批准。我们将通过会议和期刊出版物向公众传播最终结果。还将向伦理委员会提供最终研究报告。
在澳大利亚新西兰临床试验注册中心注册（ACTRN12614000916640）。
