Xu Lei, Fang Wei-Yi, Zhu Fu, Zhang Hong-Guang, Liu Kai
Department of Cardiology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.
Department of Cardiology, Shanghai XuHui Hospital, Zhongshan Hospital, FuDan University, Shanghai, China.
Trials. 2017 May 25;18(1):236. doi: 10.1186/s13063-017-1970-z.
Hypertension is a major risk factor for cardiovascular disease, and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCPs) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China.
METHODS/DESIGN: Patients with hypertension receiving care at four community healthcare centers that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have had uncontrolled BP in the previous 3 months and access to mobile Internet. Study subjects are randomly assigned to three interventional groups: (1) usual care; (2) home-based BP telemonitor with embedded Global System for Mobile Communications (GSM) module and unlimited data plan, an app to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or (3) this plus coordinated PCP-cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes are changes of diastolic blood pressure, HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale.
This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model that incorporates the latest telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of patients with uncontrolled hypertension.
ClinicalTrials.gov, NCT02919033 . Registered on 23 September 2016.
高血压是心血管疾病的主要危险因素，其控制率在全球范围内一直较低。研究发现，在随机对照试验中，远程监测血压有助于控制高血压。然而，对于其在结构化初级保健模式中的效果知之甚少，在这种模式中，初级保健医生（PCP）与心脏病专家合作进行电子医疗数据共享和医疗干预。本研究旨在确定应用远程医疗工具促进中国社区高血压控制的初级保健医生 - 心脏病专家协作模式的效果。
方法/设计：在上海交通大学附属上海胸科医院的四家社区医疗中心接受治疗的高血压患者，如果他们在过去3个月内血压未得到控制且能够访问移动互联网，则符合条件。研究对象被随机分配到三个干预组：（1）常规护理；（2）基于家庭的血压远程监测，配备嵌入式全球移动通信系统（GSM）模块和无限数据套餐，一个用于访问个人健康记录并接收个性化生活方式指导内容的应用程序，以及使用方法的熟练培训；或（3）在此基础上加上初级保健医生 - 心脏病专家的协作护理，即初级保健医生和心脏病专家通过安全的CareLinker网站共享数据以确定干预方法。主要结局是12个月期间收缩压的平均变化。次要结局是舒张压、糖化血红蛋白、血脂的变化以及通过八项Morisky药物依从性量表测量的药物依从性。
本研究将确定结合最新远程医疗技术的初级保健医生 - 心脏病专家远程医疗协作模式是否能改善高血压护理。该模式的成功将有助于简化当前的社区医疗流程，并影响更多血压未得到控制的患者。
ClinicalTrials.gov，NCT02919033。于2016年9月23日注册。
