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

September 28, 2016 updated by: Xu Lei

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hostpital
        • Contact:
          • Lei Xu, Master
          • Phone Number: 86-21-32260806
          • Email: waqyl@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mean SBP
Time Frame: 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.
From baseline (T1) to 12 months (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mean DBP
Time Frame: 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"
From baseline (T1) to 12 months (T3)
Hypertension control rate
Time Frame: 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).
From baseline (T1) to 6 months (T2) and 12 months (T3)
Anti-hypertensive medication adherence
Time Frame: 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).
At baseline (T1) and 12 months (T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xu Lei

Investigators

  • Principal Investigator: Lei Xu, Master, Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (ESTIMATE)

September 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC12015308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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