Key result
This study protocol outlines a randomized controlled trial to evaluate whether a pathway-driven eHealth-based integrated care model reduces systolic blood pressure over 12 months compared to usual care in patients with uncontrolled hypertension.
Why the study?
Hypertension control requires long-term management beyond the hospital, but few studies have applied a customized integrated care model catering to the emerging three-manager mode in community-based hypertension management in China.
Does a pathway-driven eHealth-based integrated care model improve systolic blood pressure control compared to guideline-based usual care in adults with uncontrolled hypertension?
RCT (n=402)
Open-label
Block randomization
Yes
Does a pathway-driven eHealth-based integrated care model improve systolic blood pressure control compared to guideline-based usual care in adults with uncontrolled hypertension?
This study protocol outlines a randomized controlled trial to evaluate whether an eHealth-based integrated care model can improve systolic blood pressure control in Chinese patients with uncontrolled hypertension.
Awaits RCT completion before any practice shift; will test if eHealth integrated care improves SBP control in uncontrolled hypertension.
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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Wang et al. (2021) conducted an RCT in Hypertension (n=402). Pathway-driven eHealth-based integrated care model (PEICM) vs. Guideline-based management (usual care) was evaluated on Mean change in systolic blood pressure from baseline to 12 months. This study protocol outlines a randomized controlled trial to evaluate whether a pathway-driven eHealth-based integrated care model reduces systolic blood pressure over 12 months compared to usual care in patients with uncontrolled hypertension.
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