Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-01 @ 5:07 PM
Study NCT ID:
NCT02919033
Status:
UNKNOWN
Last Update Posted:
2016-09-29
First Post:
2016-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China
Sponsor:
Xu Lei
Organization:
Study Overview
Official Title:
A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: