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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Chang Hee, Lee
- Enrollment
- 440
- Locations
- 3
- Primary Endpoint
- Clinic blood pressure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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
Investigators
Chang Hee, Lee
Chief Research Engineer
LG Electronics Inc.
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- 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)
- Medication compliance(24 weeks)
- Reduction of body mass index(24 weeks)
- Assessment of patients' satisfaction(24 weeks)