Effects of Telemonitoring and Telemedicine Service for Hypertensive Care

NCT01335984 | Completed DMC

• 1 other identifier: SmartCare-HTN
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypertension

Keywords

telemonitoring; usual care; telemedicine; telehealth; home care; Health Care Quality; Access; Evaluation

Outcome Measures

Primary Outcomes (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

  24 weeks

Secondary Outcomes (8)

• Clinic blood pressure-Diastolic Blood Pressure(DBP)

  24 weeks

• Percentage of subjects who achieved goal clinic blood pressure

  24 weeks

• 24 hours ABP(Ambulatory Blood Pressure)

  24 weeks

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

  24 weeks

• Self blood pressure measurement

  24 weeks

Study Arms (3)

Telemonitoring group

EXPERIMENTAL

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

Telemonitoring & Telemedicine group

EXPERIMENTAL

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

Control group

OTHER

The subjects who are assigned in the Control group require site visit once per 2 months (8weeks)

Other: control group

Interventions

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.

Also known as: Smartcare System : Telemonitoring

Telemonitoring group

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.

Also known as: Smartcare System : Telemonitoring & Telemedicine

Telemonitoring & Telemedicine group

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).

Also known as: Self-BP measuring

Control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Hee, Lee: lead
• LG Electronics Inc.: collaborator
• Purdue University: collaborator

Study Sites (3)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telemedicine; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sungha Park, M.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Research Engineer

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 15, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

KR (3)