Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
450 participants
INTERVENTIONAL
2023-03-02
2024-02-28
Brief Summary
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Detailed Description
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The patients with 24-hour ambulatory systolic BP 130-159 mmHg and serum LDL-cholesterol \<130 mg/dl were classified as \[Category 1\]. \[Category 2\] includes the patients with 24-hour ambulatory systolic BP \<130 mmHg and serum LDL-cholesterol ≥130 mg/dl. The patients with 24-hour ambulatory systolic BP 130-159 mmHg and serum LDL-cholesterol ≥130 mg/dl are included in \[Category 3\]. The subjects in each category will be randomly allocated into the intervention and control groups as a ratio 1:1.
All participants will respond a baseline questionnaire about health habits, health behavior patterns and quality of life, diet, exercise, etc. They are provided with details on lifestyle modifications, as recommended by the Korean Society of Hypertension and/or the Korean society of lipid \& atherosclerosis. The patients in the intervention group will wear a smart watch (Galaxy watch4, Samsung Electronics Co., Ltd.) collecting their physical data (BP, heart rate, activity, fitness, etc.), and will use the smartphone application (Second Wind, Medi Plus Solution Co., Ltd.) that provides the personalized healthcare services for lifestyle modification in chronic disease (nutrition, activities \& exercise, weight \& BP control, sleep, stress, medication, smoking cessation), health education and online consulting. In the control group, a take-home book about chronic illness will be given for self-education.
At 12-week follow-up, 24-hour ambulatory BP monitoring and serum LDL-cholesterol measurement will be repeatedly done. The primary endpoints are (1) the mean change in 24-hour ambulatory systolic BP from baseline to 12 weeks in patients with hypertension \[Category 1 \& 3\], and (2) the mean change in serum LDL-cholesterol from baseline to 12 weeks in patients with hyperlipidemia \[Category 2 \& 3\].
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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smart group
Smartphone App-based healthcare
App-guided lifestyle modification
Smart watch and smartphone application-based life style modification for 12 weeks
control group
a book-based self-education
A book-based self-education of lifestyle modification
A take-home book-based self-education for lifestyle modification
Interventions
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App-guided lifestyle modification
Smart watch and smartphone application-based life style modification for 12 weeks
A book-based self-education of lifestyle modification
A take-home book-based self-education for lifestyle modification
Eligibility Criteria
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Inclusion Criteria
* 24-hour ambulatory systolic BP 130-159 mmHg or serum LDL ≥130 mg/dl
* Android smartphone users who can use ICT-based helathcare application
* no use of anti-hypertensive or lipid-lowering drugs for ≥3 months prior to screening
* subjects who are considered appropriate to be managed with lifestyle modification for 12 weeks
* Subject who understands the purpose of the study and signs with informed consent form
Exclusion Criteria
* underlying cardiovascular disease (ischemic heart disease, heart failure, aortic disease, valvular heart disease, arrhythmia, cardiomyopathy, etc.)
* underlying cerebrovascular disease (stroke, cerebral infarction or hemorrhage, cerebral aneurysm, etc.)
* chronic renal disease
* peripheral vascular disease
* pregnancy
* secondary hypertension
* atrial fibrillation or flutter
* severe bradyarrhythmia
* difficulty in BP measurement by smart watch
* difference in systolic BP measurements from both arms \> 10mmHg
* life expectancy \< 2 years
* medical conditions that would limit adherence to participation (as confirmed by physicians)
20 Years
54 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Soo-Jin Kang
MD., PhD.
Central Contacts
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Other Identifiers
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2023-0003
Identifier Type: -
Identifier Source: org_study_id
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