Clinical trial NCT02919033: Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China
Official title: A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: randomized controlled trial
telemedicine
hypertension
primary care
medication adherence
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 330
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in mean SBP
timeFrame: From baseline (T1) to 12 months (T3)
Secondary outcomes:
measure: Changes in mean DBP
timeFrame: From baseline (T1) to 12 months (T3)
measure: Hypertension control rate
timeFrame: From baseline (T1) to 6 months (T2) and 12 months (T3)
measure: Anti-hypertensive medication adherence
timeFrame: At baseline (T1) and 12 months (T3).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hostpital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Lei Xu, Master
role: PRINCIPAL_INVESTIGATOR
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