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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02919033
• Other study ID #: SHDC12015308
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: September 28, 2016
• Start date: September 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2016
• Source: Shanghai Chest Hospital
• Contact: Lei Xu, Master
• Phone: 86-21-32260806
• Email: waqyl[@]126.com
• Is FDA regulated: No
• Health authority: China:Shanghai Shenkang Hospital Development Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

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.

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.

Locations

Country	Name	City	State
China	Shanghai Chest Hostpital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xu Lei

Country where clinical trial is conducted

China, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean SBP	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.	From baseline (T1) to 12 months (T3)	No
Secondary	Changes in mean DBP	Changes of DBP will be determined at the same time as SBP, as described in the session of "Primary Outcome Measure"	From baseline (T1) to 12 months (T3)	No
Secondary	Hypertension control rate	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).	From baseline (T1) to 6 months (T2) and 12 months (T3)	No
Secondary	Anti-hypertensive medication adherence	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).	At baseline (T1) and 12 months (T3).	No