- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335984
Effects of Telemonitoring and Telemedicine Service for Hypertensive Care (Smart-HTN)
A Multi-center, Randomized, Parallel, Interventional, Open Label Trial to Compare the Blood Pressure-lowering Effect of Conventional Treatment and Smart Care Service in Hypertensive Patients Receiving Any Conventional Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- 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
- 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
- Target Subject: Hypertensive patients receiving any conventional antihypertensive medication
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
-
Daegu, Korea, Republic of
- Yeungnam University Medical Center
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Seoul, Korea, Republic of
- Yonsei University Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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
- 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:
- Patients with severe hypertension (mean of two seated SBP ≥200 mmHg) at screening visit blood pressure measurement.
- Patients with secondary hypertension.
- HbA1c>11%.
- Patients are currently being hospitalized or planning to hospitalize due to hypertension.
- Patients with severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
- Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
- 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.
- Patients with phthisis, autoimmune disease or connective tissue disease.
- Patients on medication therapies which may interfere with their blood pressure.
- Patients with known history of allergic reaction or contraindication to angiotensin II antagonists.
- Pregnant or lactating woman.
- Patients with known history of alcoholism, mental illness, or drug dependency.
- Patients who have participated in other study within 12 weeks prior to screening visit.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
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.
Other Names:
|
Experimental: 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.
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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 Names:
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Other: Control group
The subjects who are assigned in the Control group require site visit once per 2 months (8weeks)
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinic blood pressure
Time Frame: 24 weeks
|
blood pressure value when hospital visiting
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinic blood pressure-Diastolic Blood Pressure(DBP)
Time Frame: 24 weeks
|
Changes in mean Diastolic Blood Pressure(DBP) from baseline to 24 weeks visit
|
24 weeks
|
Percentage of subjects who achieved goal clinic blood pressure
Time Frame: 24 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)
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24 weeks
|
24 hours ABP(Ambulatory Blood Pressure)
Time Frame: 24 weeks
|
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24 weeks
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Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal
Time Frame: 24 weeks
|
|
24 weeks
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Self blood pressure measurement
Time Frame: 24 weeks
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Mean value of each week of self blood pressure measurement (Systolic/Diastolic) from baseline to 24 weeks
|
24 weeks
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Medication compliance
Time Frame: 24 weeks
|
|
24 weeks
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Reduction of body mass index
Time Frame: 24 weeks
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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
Time Frame: 24 weeks
|
Only remote monitoring group and remote visit + remote monitoring group are applicable
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sungha Park, M.D., Yonsei University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SmartCare-HTN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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