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

NCT02919033 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2016-09-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Xu Lei

    lead OTHER

Principal Investigators

  • Lei Xu, Master · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919033 on ClinicalTrials.gov