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

Chang Hee, Lee

Status: Completed

Conditions: Hypertension

Treatments: Other: control group; Procedure: Telemonitoring & Telemedicine; Procedure: Telemonitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01335984

SmartCare-HTN

Details and patient eligibility

About

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.

Full 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

Enrollment: 440 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 3 patient groups

Telemonitoring group

Experimental group

Description:

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)

Treatment:

Procedure: Telemonitoring

Telemonitoring & Telemedicine group

Experimental group

Description:

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.

Treatment:

Procedure: Telemonitoring & Telemedicine

Control group

Other group

Description:

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

Treatment:

Other: control group