Trials (Jan 2021)

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

  • Zheyu Wang,
  • Chengling Li,
  • Wencai Huang,
  • Yan Chen,
  • Yuqiong Li,
  • Libin Huang,
  • Mei Zhang,
  • Dan Wu,
  • Li Wang,
  • Huilong Duan,
  • Jiye An,
  • Ning Deng

DOI
https://doi.org/10.1186/s13063-021-05020-2
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 12

Abstract

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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 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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