Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China

Xu Lei

Status: Unknown

Conditions: Hypertension

Treatments: Other: PCTM intervention; Device: Self-management; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02919033

SHDC12015308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 21 years or older
2. a clinical diagnosis of hypertension with uncontrolled BP in the previous three months, currently taking or about to take anti-hypertensive medications
3. received high school or above level of education
4. active user of smart phone (Android or Apple) and mobile Apps
5. 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;
6. being able to give informed consent.

Exclusion criteria

• acute coronary syndrome
• heart failure
• cardiac arrhythmia
• stroke within the past three months
• renal failure
• cancer
• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 3 patient groups, including a placebo group

Usual care (UC)

Placebo Comparator group

Description:

Patients are managed by their PCPs at the registered CHCs as usual.

Treatment:

Other: Usual care

Self-management

Experimental group

Description:

* BP tele-monitor \& App based self-management supports * Patient proficiency training

Treatment:

Device: Self-management

PCTM intervention

Experimental group

Description:

* 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

Treatment:

Other: PCTM intervention