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.
1. Objectives : To evaluate superiority in blood pressure lowering effect of the Smart Care Service compared to the conventional treatment in hypertensive patients receiving any conventional antihypertensive medication 2. Test and control group * Control group : The subject group who is receiving any conventional treatment (hospital visit). * Test groups Conventional treatment + remote monitoring group: The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring. Remote visit + remote monitoring group: The subject group who is receiving remote visit and remote monitoring using videotelephony 3. Target Subject: Hypertensive patients receiving any conventional antihypertensive medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
440
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.
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.
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Yonsei University Health System
Seoul, South Korea
Clinic blood pressure
blood pressure value when hospital visiting * Clinic blood pressure * Changes in mean SBP(Systolic Blood Pressure) from baseline to 24 weeks visit
Time frame: 24 weeks
Clinic blood pressure-Diastolic Blood Pressure(DBP)
Changes in mean Diastolic Blood Pressure(DBP) from baseline to 24 weeks visit
Time frame: 24 weeks
Percentage of subjects who achieved goal clinic blood pressure
Percentage of subjects who achieved blood pressure under 140/90mmHg at 24 weeks visit (under 130/80mmHg in subjects with diabetes mellitus and renal disease)
Time frame: 24 weeks
24 hours ABP(Ambulatory Blood Pressure)
* BP measured at baseline and after administration of antihypertensive drugs at 24 weeks * Mean values of 24 hours blood pressure (SBP / DBP) will be used for analysis
Time frame: 24 weeks
Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal
* Percentage of subjects who achieved average daytime BP of 24hrs ABPM under 135/85mmHg (under 130/80mmHg in subjects with diabetes mellitus and renal disease) * Average daytime BP will be calculated with average of each hourly mean from 07:00 to 22:59 of the Clock time
Time frame: 24 weeks
Self blood pressure measurement
Mean value of each week of self blood pressure measurement (Systolic/Diastolic) from baseline to 24 weeks
Time frame: 24 weeks
Medication compliance
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\- 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).
* Patients diary will be recorded and medication compliance will be calculated by calculating the number of days administered antihypertensive drugs during the study * Drugs compliance = the number of days administered antihypertensive drugs / participated period in this study \* 100%
Time frame: 24 weeks
Reduction of body mass index
Changes of Body Mass Index(BMI) \- Body Mass Index(BMI)=Body weight (kg)/Height2(m) from baseline to 24 weeks
Time frame: 24 weeks
Assessment of patients' satisfaction
Only remote monitoring group and remote visit + remote monitoring group are applicable
Time frame: 24 weeks