Effects of Telemonitoring and Telemedicine Service for Hypertensive Care

Summary

This is a multi-centered, randomized, parallel group, interventional \& open label clinical trial accessing efficacy of intervention effect by smart care system over existing treatment group for lowering blood pressure of hypertension patients taking anti-hypertension drug.

Conditions

• Hypertension

Interventions

PROCEDURE

Telemonitoring

The subjects who are assigned in the Telemonitoring group will be provided Blood Pressure monitor, body composition analyzer, and remote monitoring device. The subjects who are assigned in the Telemonitoring group should visit the site once per every 2 months (8 weeks), and they should measure their blood pressure using a provided blood pressure monitor twice a day during study period (once after first morning urination and once before going to bed). After measurement of blood pressure and body composition, the subjects should make the transmission terminals of remote monitoring device situate near transmission terminal of Smart Care PC and transmit measured information through Smart Care PC into a centralized server of Smart Care Center.

PROCEDURE

Telemonitoring & Telemedicine

The subjects who are assigned in the Telemonitoring \& Telemedicine group should perform the same remote monitoring procedures as the subjects in the Telemonitoring group. Since the remote visit substitute for a face to face visit, subjects should reserve the time for remote visit in each clinical trial center. A primary doctor or remote medical doctor should provide medical consultation to the subjects through videotelephony using the remote monitoring device and then issue electronic prescriptions.

OTHER

control group

\- The subjects who are assigned in the control group will be provided blood Pressure Monitor (Self BP measuring). The subjects who are assigned in the control group should perform the same blood pressure measurement (2 times a day) same as the test group during the study, and measured results should be recorded in a diary of self blood pressure measurement. In addition, the subjects should visit the site once per every two months (8 weeks).

Sponsors & Collaborators

• LG Electronics Inc.

  collaborator INDUSTRY

• Purdue University

  collaborator OTHER

• Chang Hee, Lee

  lead INDUSTRY

Principal Investigators

• Sungha Park, M.D. · Yonsei University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2013-04-30

Completion

2013-08-31

Countries

• South Korea

Study Locations