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

Sponsor

Xu Lei (Other)

Overall Status

Unknown status

CT.gov ID

NCT02919033

Collaborator

(none)

330

Enrollment

Location

Arms

Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Usual care Device: Self-management Other: PCTM intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

A Coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's Community Hypertension Care: Study Protocol for a Randomized Controlled Trial

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Usual care (UC) Patients are managed by their PCPs at the registered CHCs as usual.	Other: Usual care The hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients.
Experimental: Self-management BP tele-monitor & App based self-management supports Patient proficiency training	Device: Self-management Usual care Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging. All patients receive proficiency training in using the BP tele-monitor, and mobile App.
Experimental: 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	Other: PCTM intervention Usual care Self-management PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs. PCPs and cardiologists receive training of the CareLinker website.

Arm

Intervention/Treatment

Placebo Comparator: Usual care (UC)

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

Other: Usual care

The hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients.

Experimental: Self-management

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

Device: Self-management

Usual care Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging. All patients receive proficiency training in using the BP tele-monitor, and mobile App.

Experimental: 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

Other: PCTM intervention

Usual care Self-management PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs. PCPs and cardiologists receive training of the CareLinker website.

Outcome Measures

Primary Outcome Measures

Changes in mean SBP [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.

Secondary Outcome Measures

Changes in mean DBP [From baseline (T1) to 12 months (T3)]
Changes of DBP will be determined at the same time as SBP, as described in the session of "Primary Outcome Measure"
Hypertension control rate [From baseline (T1) to 6 months (T2) and 12 months (T3)]
Hypertension control rate defined as BP < 140/90 mm Hg or < 130/80 mm Hg (patients of diabetes or renal diseases) following the national guidelines, and changes in measures related to hypertension complications (HbA1C, BMI, and lipid levels) from baseline (T1) to 6 months (T2) and 12 months (T3).
Anti-hypertensive medication adherence [At baseline (T1) and 12 months (T3).]
Adherence is assessed by self-report, eight-item Morisky Medication Adherence Scale MMAS modified to focus on BP drugs at baseline (T1) and 12 months (T3).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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.