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Completed

NCT Number: NCT01335984

Effects of Telemonitoring and Telemedicine Service for Hypertensive Care

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Dongsan Medical Center, Daegu, South Korea

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Smartcare System : Telemonitoring

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.

Other names: Smartcare System : Telemonitoring & Telemedicine

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).

Other names: Self-BP measuring

Primary outcomes

  1. Clinic blood pressure

    Time frame: 24 weeks

    blood pressure value when hospital visiting

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

Secondary outcomes

  1. Clinic blood pressure-Diastolic Blood Pressure(DBP)

    Time frame: 24 weeks

    Changes in mean Diastolic Blood Pressure(DBP) from baseline to 24 weeks visit

  2. 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)

  3. 24 hours ABP(Ambulatory Blood Pressure)

    Time frame: 24 weeks

    • 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

  4. Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal

    Time frame: 24 weeks

    • 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

  5. Self blood pressure measurement

    Time frame: 24 weeks

    Mean value of each week of self blood pressure measurement (Systolic/Diastolic) from baseline to 24 weeks

  6. Medication compliance

    Time frame: 24 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%

  7. Reduction of body mass index

    Time frame: 24 weeks

    Changes of Body Mass Index(BMI)

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

  8. Assessment of patients' satisfaction

    Time frame: 24 weeks

    Only remote monitoring group and remote visit + remote monitoring group are applicable

Sponsors and collaborators

Lead sponsor

Chang Hee, Lee

Industry

Collaborators

  • LG Electronics Inc.
  • Purdue University

Registry information

Official study 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

Acronym: Smart-HTN

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2011
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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