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HypertensionSmart-HTNNCT01335984

Effects of Telemonitoring and Telemedicine Service for Hypertensive Care

A study testing Telemonitoring and Telemonitoring & Telemedicine in people with Hypertension, run by Chang Hee, Lee at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Hypertension
What is being tested?
Telemonitoring and Telemonitoring & Telemedicine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
3 sitesSouth Korea
Study dates
Jan 2011to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • Yonsei University Health System

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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
  1. Target Subject: Hypertensive patients receiving any conventional antihypertensive medication
Conditions
Hypertension
Being tested
Telemonitoring, Telemonitoring & Telemedicine, control group
Keywords
telemonitoring, usual care, telemedicine, telehealth, home care, Health Care Quality, Access, Evaluation
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemonitoringProcedure or surgery

    Also called Smartcare System : 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 & TelemedicineProcedure or surgery

    Also called Smartcare System : 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 groupOther

    Also called Self-BP measuring

    • 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).

Study groups in NCT01335984
Study groupRoleWhat they receive
Telemonitoring groupExperimentalThe 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)
Receives: Procedure: Telemonitoring
Telemonitoring & Telemedicine groupExperimentalThe 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.
Receives: Procedure: Telemonitoring & Telemedicine
Control groupOtherThe subjects who are assigned in the Control group require site visit once per 2 months (8weeks)
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinic blood pressure

    blood pressure value when hospital visiting

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

    Measured: 24 weeks

Secondary outcomes (8)

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

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

    Measured: 24 weeks

  2. Percentage of subjects who achieved goal clinic blood pressure

    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)

    Measured: 24 weeks

  3. 24 hours ABP(Ambulatory Blood Pressure)

    • 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

    Measured: 24 weeks

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

    • 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

    Measured: 24 weeks

  5. Self blood pressure measurement

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

    Measured: 24 weeks

  6. Medication compliance

    • 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%

    Measured: 24 weeks

  7. 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

    Measured: 24 weeks

  8. Assessment of patients' satisfaction

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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335984
Sponsor's protocol ID
SmartCare-HTN
Acronym
Smart-HTN
Status last verified
Jan 2020
First submitted
31 Mar 2011
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring and Telemonitoring & Telemedicine in people with Hypertension, run by Chang Hee, Lee at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinic blood pressure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01335984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

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