Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LG Electronics Inc. | INDUSTRY |
| Purdue University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Test and control group
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
Target Subject: Hypertensive patients receiving any conventional antihypertensive medication
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | Experimental | The subjects who are assigned in the Telemonitoring group should perform body composition measurement with self blood pressure measurement, and shall transmit the results to the Smart Care Serve via Smart Care PC. Telemonitoring group require site visit once per 2 months (8weeks) |
|
| Telemonitoring & Telemedicine group | Experimental | The subjects who are assigned in the Telemonitoring & Telemedicine group should perform body composition measurement with self blood pressure measurement, and shall transmit the results to the Smart Care Serve via Smart Care PC. Telemonitoring & Telemedicine group take remote medical treatment through video telephone instead of visiting study site. |
|
| Control group | Other | The subjects who are assigned in the Control group require site visit once per 2 months (8weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic blood pressure | blood pressure value when hospital visiting
| 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic blood pressure-Diastolic Blood Pressure(DBP) | Changes in mean Diastolic Blood Pressure(DBP) from baseline to 24 weeks visit | 24 weeks |
| Percentage of subjects who achieved goal clinic blood pressure |
Not provided
Inclusion Criteria:
Male and female patients who are able to receive outpatient treatment from over 20 to under 70 years of age.- Over SBP 140mmHg without diabetes or renal failure
Patients who are taking more than one kind of any antihypertensive medications
Patients who are able to understand the purpose of this trial and to read and write
Patients who are able to use Smart Care PC for this trial
Patients who participate voluntarily and sign the informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sungha Park, M.D. | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | South Korea | ||||
| Yeungnam University Medical Center |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D015340 | Epidemiologic Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Telemonitoring & Telemedicine | Procedure | 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. |
|
|
| control group | Other | - 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). |
|
|
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)
| 24 weeks |
| 24 hours ABP(Ambulatory Blood Pressure) |
| 24 weeks |
| Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal |
| 24 weeks |
| Self blood pressure measurement | Mean value of each week of self blood pressure measurement (Systolic/Diastolic) from baseline to 24 weeks | 24 weeks |
| Medication compliance |
| 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 | 24 weeks |
| Assessment of patients' satisfaction | Only remote monitoring group and remote visit + remote monitoring group are applicable | 24 weeks |
| Daegu |
| South Korea |
| Yonsei University Health System | Seoul | South Korea |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |