Mobile Application for Cardiovascular Risk Treatment (iSMART-CV)

Asan Medical Center

Status: Not yet enrolling

Conditions: Hypertension; Lifestyle Risk Reduction; Chronic Disease; Hyperlipidemias

Treatments: Behavioral: A book-based self-education of lifestyle modification; Behavioral: App-guided lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT05712070

2023-0003

Details and patient eligibility

About

This study is a randomized, open-label clinical trial to validate the efficacy and safety of smartphone app-guided life style modification for the management of hypertension and hyperlipidemia.

Full description

The aim of the study is to verify the blood pressure (BP) reduction and lipid-lowering effect of ICT-based healthcare program (intervention) vs. conventional strategy (control). Health insurance subscribers (KYOBO Life Insurance Co., Ltd.) who are aged 20-54 years, and have a recent record of an office BP ≥140/90 mmHg or serum LDL-cholesterol ≥130 mg/dl will be recruited. Among them, android smartphone users with no use of anti-hypertensive or lipid-lowering drugs for ≥3 months prior to screening will be referred to physicians in Asan Medical Center, and 24-hour ambulatory BP monitoring and serum LDL-cholesterol will be checked for screening. Finally, the patients who have a diagnosis of essential hypertension (24-hour ambulatory systolic BP 130-159 mmHg) or hyperlipidemia (LDL-cholesterol ≥130 mg/dl), and are considered appropriate to be managed with non-pharmacological lifestyle modification for 12 weeks will be eligible for enrollment.

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].

Enrollment: 450 estimated patients

Sex: All

Ages: 20 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• health insurance subscribers who are aged 20-54 years
• 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

• 24-hour ambulatory systolic or diastolic BP >160 mmHg or > 110 mmHg
• 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

smart group

Experimental group

Description:

Smartphone App-based healthcare

Treatment:

Behavioral: App-guided lifestyle modification

control group

Active Comparator group

Description:

a book-based self-education

Treatment:

Behavioral: A book-based self-education of lifestyle modification