Effects of Telemonitoring and Telemedicine Service for Hypertensive Care (Smart-HTN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by LG Electronics Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LG Electronics Inc.
ClinicalTrials.gov Identifier:
NCT01335984
First received: March 31, 2011
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Hypertension
Procedure: Telemonitoring
Procedure: Telemonitoring & Telemedicine
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LG Electronics Inc.:

Primary Outcome Measures:
  • Clinic blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    blood pressure value when hospital visiting

    • Clinic blood pressure
    • Changes in mean SBP(Systolic Blood Pressure) from baseline to 24 weeks visit


Secondary Outcome Measures:
  • Clinic blood pressure-Diastolic Blood Pressure(DBP) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes in mean Diastolic Blood Pressure(DBP) from baseline to 24 weeks visit

  • Percentage of subjects who achieved goal clinic blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 hours ABP(Ambulatory Blood Pressure) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    • 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

  • Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    • 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

  • Self blood pressure measurement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Mean value of each week of self blood pressure measurement (Systolic/Diastolic) from baseline to 24 weeks

  • Medication compliance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    • 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%

  • Reduction of body mass index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Changes of Body Mass Index(BMI)

    - Body Mass Index(BMI)=Body weight (kg)/Height2(m) from baseline to 24 weeks


  • Assessment of patients' satisfaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Only remote monitoring group and remote visit + remote monitoring group are applicable


Estimated Enrollment: 564
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.

Other Name: Smartcare System : Telemonitoring
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.
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 Name: Smartcare System : Telemonitoring & Telemedicine
No Intervention: Control group
The subjects who are assigned in the Control group require site visit once per 2 months (8weeks)
Other: Usual Care

The subjects who are assigned in the control group will be provided blood Pressure Monitor.

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 Name: Self blood pressure measurement

Detailed Description:
  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
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  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:

  1. Patients with severe hypertension (mean of two seated SBP ≥200 mmHg) at screening visit blood pressure measurement.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335984

Contacts
Contact: Jeongweon Park 82-10-2357-0538 Jeongweon.Park@lge.com
Contact: Youngdon Hwang 82-10-7575-0406 youngdon.hwang@lge.com

Locations
Korea, Republic of
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Don-gu Shin, M.D.    82-53-620-3843      
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Yun-nun Kim, M.D.    82-53-250-7432      
Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Sungha Park, M.D.    82-2-2228-8455      
Sponsors and Collaborators
LG Electronics Inc.
Investigators
Principal Investigator: Sungha Park, M.D. Yonsei University
  More Information

No publications provided

Responsible Party: Youngdon Hwang/Chief Research Engineer, LG Electronics Inc.
ClinicalTrials.gov Identifier: NCT01335984     History of Changes
Other Study ID Numbers: SmartCare-HTN
Study First Received: March 31, 2011
Last Updated: April 28, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by LG Electronics Inc.:
telemonitoring
usual care
telemedicine
telehealth
home care
Health Care Quality
Access
Evaluation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014