Hypertension Clinical Trial
Official title:
A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
This three arm study is to compare the effects of a coordinated PCP-Cardiologist Telemedicine Model (PCTM) with usual care and self-care in community hypertension management in China.
Background: Hypertension is a major risk factor for cardiovascular diseases 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 (PCP) 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: Hypertensive patients receiving care at four community healthcare centers
(CHCs) that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong
University are eligible if they have uncontrolled blood pressure in the previous three
months and access to mobile internet. Study subjects are randomly assigned to three
interventional groups: 1) usual care; 2) home-based BP tele-monitor with embedded 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 (SBP) over a 12-month period. Secondary outcomes are
changes of diastolic blood pressure (DBP), HbA1C, blood lipids, and medication adherence
measured by the eight-item Morisky Medication Adherence Scale MMAS.
Discussion: This study will determine whether a coordinated PCP-Cardiologist Telemedicine
Model (PCTM) that incorporates the lasted telemedicine technologies will improve
hypertension care. Success of the model would help streamline the present community
healthcare processes and impact a greater number of uncontrolled hypertensive patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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