Clinical trial NCT01335984: Effects of Telemonitoring and Telemedicine Service for Hypertensive Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: telemonitoring
usual care
telemedicine
telehealth
home care
Health Care Quality
Access
Evaluation
Lead sponsor: LG Electronics Inc.
Sponsor class: INDUSTRY
Collaborators: name: LG Electronics Inc.
name: Purdue University
First posted: 2011-04-15
Enrollment: 440
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Clinic blood pressure
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinic blood pressure-Diastolic Blood Pressure(DBP)
timeFrame: 24 weeks
measure: Percentage of subjects who achieved goal clinic blood pressure
timeFrame: 24 weeks
measure: 24 hours ABP(Ambulatory Blood Pressure)
timeFrame: 24 weeks
measure: Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal
timeFrame: 24 weeks
measure: Self blood pressure measurement
timeFrame: 24 weeks
measure: Medication compliance
timeFrame: 24 weeks
measure: Reduction of body mass index
timeFrame: 24 weeks
measure: Assessment of patients' satisfaction
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
Study officials:
affiliation: Yonsei University
name: Sungha Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References: