A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Changes in mean SBP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 21 years or older
- •a clinical diagnosis of hypertension with uncontrolled BP in the previous three months, currently taking or about to take anti-hypertensive medications
- •received high school or above level of education
- •active user of smart phone (Android or Apple) and mobile Apps
- •the average of three BP measurements during the screening visit at the CHC is ≥ 140/90 mm Hg, or ≥ 130/80 mm Hg if the patient has diabetes or renal diseases;
- •being able to give informed consent.
排除标准
- •acute coronary syndrome
- •heart failure
- •cardiac arrhythmia
- •stroke within the past three months
- •renal failure
- •dementia, severe or acute psychiatric illness, pregnancy or intention to be pregnant in the next 18 months, and hospitalization within 3 months.
- •additional exclusion criteria include participation in another clinical trial, arm
- •circumference >32 centimeters that may affect the accuracy of BP measurement due to cuff size limit of the tele-monitor's, and unwillingness to comply with the 12 month intervention duration.
研究组 & 干预措施
Usual care (UC)
Patients are managed by their PCPs at the registered CHCs as usual.
干预措施: Usual care (Other)
Self-management
- BP tele-monitor & App based self-management supports
- Patient proficiency training
干预措施: Self-management (Device)
PCTM intervention
- BP tele-monitor & App-based self-management supports
- Patient proficiency training
- PCP & cardiologist training of using Web-based analytics
- Proactive and interactive care by PCPs and cardiologists
干预措施: PCTM intervention (Other)
结局指标
主要结局
Changes in mean SBP
时间窗: From baseline (T1) to 12 months (T3)
The primary endpoint of the trial is changes in mean SBP from baseline (T1) to 12 months (T3) measured using the BP tele-monitor (Bliss BL928). The 12 months BP readings will be determined by taking the average of three BP measurements at the follow-up visit to the CHC. All BP data are collected and uploaded simultaneously to the trial database.
次要结局
- Changes in mean DBP(From baseline (T1) to 12 months (T3))
- Hypertension control rate(From baseline (T1) to 6 months (T2) and 12 months (T3))
- Anti-hypertensive medication adherence(At baseline (T1) and 12 months (T3).)
研究者
Xu Lei
Associate Chief
Shanghai Chest Hospital