Effectiveness of a Pathway-driven eHealth-based Integrated Care Model (PEICM) for community-based hypertension management in China: study protocol for a randomized controlled trial

• DOI: 10.21203/rs.2.24790/v1
• Publication Date: 2020-02-27T22:44:10Z
• Authors: Zheyu Wang; Chengling Li; Wencai Huang; Yan Chen; Yuqiong Li; Libin Huang; Mei Zhang; Dan Wu; Li Wang; Huilong Duan; Jiye An; Ning Deng
• Keywords: Medicine (General); China; Delivery of Health Care, Integrated; Integrated care; Blood Pressure; Community; Hypertension management; 16. Peace & justice; Telemedicine; 3. Good health; Study Protocol; 03 medical and health sciences; Telehealth; R5-920; 0302 clinical medicine; Study protocol; Hypertension; Humans; Pathway; Randomized Controlled Trials as Topic

Abstract Background: 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.Methods: The trial has been designed as a one-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.Discussion: This study aims to determine 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.Trial registration: Chinese Clinical Trial Registry ChiCTR1900027645, registered on November 22, 2019.