Effects of Telemonitoring and Telemedicine Service for Hypertensive Care
NCT ID: NCT01335984
Last Updated: 2020-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
440 participants
INTERVENTIONAL
2011-01-31
2013-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Telemonitoring group
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
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.
Telemonitoring & Telemedicine group
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.
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.
Control group
The subjects who are assigned in the Control group require site visit once per 2 months (8weeks)
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).
Interventions
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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.
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are taking more than one kind of any antihypertensive medications
* Systolic blood pressure (SBP) ≥ 140mmHg in patient with diabetes mellitus and renal disease or
* Systolic blood pressure (SBP) ≥ 130mmHg in patient without diabetes mellitus and renal disease
3. Patients who are able to understand the purpose of this trial and to read and write
4. Patients who are able to use Smart Care PC for this trial
5. Patients who participate voluntarily and sign the informed consent
Exclusion Criteria
2. Patients with secondary hypertension.
3. HbA1c\>11%.
4. Patients are currently being hospitalized or planning to hospitalize due to hypertension.
5. Patients with severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
6. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
7. Patients who have been suffered cardiac infarction or severe coronary artery disease within 6 months, or with clinically significant congestive heart failure or heart valve defects.
8. Patients with phthisis, autoimmune disease or connective tissue disease.
9. Patients on medication therapies which may interfere with their blood pressure.
10. Patients with known history of allergic reaction or contraindication to angiotensin II antagonists.
11. Pregnant or lactating woman.
12. Patients with known history of alcoholism, mental illness, or drug dependency.
13. Patients who have participated in other study within 12 weeks prior to screening visit.
14. Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
20 Years
70 Years
ALL
No
Sponsors
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LG Electronics Inc.
INDUSTRY
Purdue University
OTHER
Chang Hee, Lee
INDUSTRY
Responsible Party
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Chang Hee, Lee
Chief Research Engineer
Principal Investigators
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Sungha Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Yonsei University Health System
Seoul, , South Korea
Countries
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Other Identifiers
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SmartCare-HTN
Identifier Type: -
Identifier Source: org_study_id
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