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.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Delivery of Health Care, Integrated* ; Hypertension*/diagnosis ; Hypertension*/therapy ; Telemedicine*; Blood Pressure ; China ; Humans ; Randomized Controlled Trials as Topic

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 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.
Discussion: 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.
Trial Registration: Chinese Clinical Trial Registry ChiCTR1900027645 . Registered on November 22, 2019.

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2017YFC0114105 National Key Research and Development Program of China; 2018YFC0910503 National Key Research and Development Program of China; 2017YFB1002301 National Key Research and Development Program of China; 2018BFG02009 Key Research and Development Program of Ningxia Hui Autonomous of China

Keywords: Community; Hypertension management; Integrated care; Pathway; Randomized controlled trial; Study protocol; Telehealth

Date Created: 20210123 Date Completed: 20210617 Latest Revision: 20210617

20221213

PMC7820518

10.1186/s13063-021-05020-2

33482896