College of Biomedical Engineering and Instrument Science, The Ministry of Education Key Laboratory of Biomedical Engineering, Zhejiang University, Hangzhou, 310027, China.
The First People's Hospital of Yibin, Yibin, China.
Trials. 2021 Jan 22;22(1):81. doi: 10.1186/s13063-021-05020-2.
The prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in traditional care settings. Integrated care combined with information technology can promote high-quality healthcare services across the life-course. However, few studies have applied a customized integrated care model in community-based hypertension management in China, catering to the emerging "three-manager" mode. This study aims to identify the effectiveness of a pathway-driven eHealth-based integrated model that implemented as a full-featured telehealth system to facilitate standardized management of hypertension in China.
The trial has been designed as a 1-year, non-blinded superiority trial with two parallel groups. A total of 402 hypertensive patients who meet the eligibility criteria will be recruited and randomized with a 1:1 allocation. All the participants will receive a mobile device for self-management, which is a part of our telehealth system. Participants in the control group will only use the device for BP measurement and receive regular follow-ups from care providers according to the guidelines. Participants in the intervention group will gain full access to the system and receive intervention based on the proposed model (a well-designed coordinated care pathway consisting of 9 tasks). Outcomes will be measured mainly on three occasions (at inclusion, at 6 months, and at 12 months). The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes include changes in diastolic blood pressure, biochemical indexes related to hypertension, lifestyles, self-management adherence, and hypertension awareness, as well as work efficiency of care providers.
This study aims to investigate whether a pathway-driven eHealth-based integrated care model based on the "three-manager" mode will improve hypertension control in China. Success of the model would help improve the quality of present community-based management procedures and benefit more patients with uncontrolled hypertension.
Chinese Clinical Trial Registry ChiCTR1900027645 . Registered on November 22, 2019.
近年来，中国高血压的患病率呈上升趋势且居高不下。高血压的治疗和控制需要长期的院外管理，而传统的医疗照护环境难以实施。整合照护结合信息技术可以促进全生命周期的高质量医疗服务。然而，在中国，很少有研究将定制的整合照护模式应用于社区高血压管理，以满足新兴的“三师共管”模式。本研究旨在确定一种基于路径驱动的电子健康整合模式的有效性，该模式作为一个功能齐全的远程医疗系统，促进中国高血压的标准化管理。
该试验设计为 1 年、非盲、优效性试验，采用两组平行设计。共招募 402 名符合入选标准的高血压患者，按 1:1 比例随机分组。所有参与者将获得用于自我管理的移动设备，这是我们远程医疗系统的一部分。对照组的参与者仅将设备用于血压测量，并根据指南定期接受照护者的随访。干预组的参与者将全面接入系统，并根据提出的模型（由 9 项任务组成的精心设计的协调照护路径）接受干预。主要结局将在三个时间点（入组时、6 个月时和 12 个月时）进行测量。主要结局是 12 个月期间收缩压的平均变化。次要结局包括舒张压变化、与高血压相关的生化指标变化、生活方式、自我管理依从性和高血压知晓率，以及照护者的工作效率。
本研究旨在探讨基于“三师共管”模式的路径驱动电子健康整合照护模型是否会改善中国的高血压控制。该模型的成功将有助于提高现有社区管理程序的质量，使更多的未控制高血压患者受益。
中国临床试验注册中心 ChiCTR1900027645。注册于 2019 年 11 月 22 日。
