Key result
A coordinated PCP-Cardiologist Telemedicine Model (PCTM) is being evaluated in a randomized controlled trial to determine its effect on systolic blood pressure control over 12 months compared to usual care.
Why the study?
Does a coordinated PCP-cardiologist telemedicine model improve systolic blood pressure in adult patients with uncontrolled hypertension?
RCT (n=330)
Open-label
Block randomization
Yes
Does a coordinated PCP-cardiologist telemedicine model improve systolic blood pressure in adult patients with uncontrolled hypertension?
This study protocol outlines a randomized controlled trial to evaluate whether a coordinated PCP-cardiologist telemedicine model can improve blood pressure control in community healthcare settings in China.
This RCT will test coordinated telemedicine for hypertension control; leaves open practice change until results reported.
BACKGROUND: Hypertension is a major risk factor for cardiovascular disease, and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCPs) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China. METHODS/DESIGN: Patients with hypertension receiving care at four community healthcare centers that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have had uncontrolled BP in the previous 3 months and access to mobile Internet. Study subjects are randomly assigned to three interventional groups: (1) usual care; (2) home-based BP telemonitor with embedded Global System for Mobile Communications (GSM) module and unlimited data plan, an app to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or (3) this plus coordinated PCP-cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes are changes of diastolic blood pressure, HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale. DISCUSSION: This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model that incorporates the latest telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of patients with uncontrolled hypertension. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02919033 . Registered on 23 September 2016.
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Xu et al. (2017) conducted an RCT in Hypertension (n=330). PCP-Cardiologist Telemedicine Model (PCTM) vs. Usual care or self-management using telemedicine tools was evaluated on Mean change in systolic blood pressure from baseline to 12 months. A coordinated PCP-Cardiologist Telemedicine Model (PCTM) is being evaluated in a randomized controlled trial to determine its effect on systolic blood pressure control over 12 months compared to usual care.
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