通过基于智能手机的远程监测对复杂慢性病患者进行自我管理和临床决策支持：随机对照试验方案
Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.
作者信息
Seto Emily, Ware Patrick, Logan Alexander G, Cafazzo Joseph A, Chapman Kenneth R, Segal Phillip, Ross Heather J
机构信息
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Centre for Global eHealth Innovation, Techna Institute, University Health Network, Toronto, ON, Canada.
出版信息
JMIR Res Protoc. 2017 Nov 21;6(11):e229. doi: 10.2196/resprot.8367.
BACKGROUND
The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology.
OBJECTIVE
The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions.
METHODS
A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73).
RESULTS
Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018.
CONCLUSIONS
This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions.
TRIAL REGISTRATION
International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC).
背景
慢性病患病率的上升阻碍了医疗保健系统的可持续性，因为患有复杂慢性病的患者频繁住院成本高昂。临床试验表明，远程监测可改善健康结局，但这些试验通常仅限于单一病症，如糖尿病、高血压或心力衰竭。很少有研究探讨远程监测对患有多种慢性病的复杂患者的影响，尽管这些患者可能从这项技术中获益最多。
目的
本研究旨在调查基于智能手机的远程监测系统对患有多种慢性病的复杂患者的临床护理和健康结局的影响。
方法
正在专科诊所进行一项为期6个月的基于智能手机的远程监测系统的混合方法随机对照试验（RCT）。该研究将纳入被诊断患有以下任何一种或多种病症的患者：心力衰竭、慢性阻塞性肺疾病、慢性肾脏病、未控制的高血压或需要胰岛素治疗的糖尿病。主要结局将是用SF-36测量的患者健康状况。患者将被随机分配到接受常规护理的对照组（n = 73）或除常规护理外还使用基于智能手机的远程监测系统的组（n = 73）。
结果
目前正在招募该试验的参与者。预计数据收集将于2018年秋季完成。
结论
这项随机对照试验将是首批提供证据证明远程监测对可能患有多种慢性病的复杂患者的成本和健康结局有影响的试验之一。
试验注册
国际标准随机对照试验编号（ISRCTN）：41238563；http://www.isrctn.com/ISRCTN41238563（由WebCite存档于http://www.webcitation.org/6ug2Sk0af）以及Clinicaltrials.gov NCT03127852；https://clinicaltrials.gov/ct2/show/NCT03127852（由WebCite存档于http://www.webcitation.org/6uvjNosBC）。
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