Mobile Application for Cardiovascular Risk Treatment (iSMART-CV)

Impact of Smart Watch Mobile Application on Risk Treatment of CardioVascular Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Chronic Disease; Hyperlipidemias; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: App-guided lifestyle modification; Behavioral: A book-based self-education of lifestyle modification

Detailed 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].

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soo-Jin Kang, M.D.; Phone Number: +82230103157; Email: sjkang3157@gmail.com
• Study Contact Backup: Name: Tae-Oh Kim, M.D.; Phone Number: +82230103150; Email: allldie@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 54 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: smart group; Smartphone App-based healthcare	Behavioral: App-guided lifestyle modification; Smart watch and smartphone application-based life style modification for 12 weeks
ACTIVE_COMPARATOR: control group; a book-based self-education	Behavioral: A book-based self-education of lifestyle modification; A take-home book-based self-education for lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in 24-hour ambulatory systolic BP from baseline to 12 weeks	in patients with hypertension [Category 1 & 3]	at 12-week follow-up
Mean change in serum LDL-cholesterol level from baseline to 12 weeks	in patients with hyperlipidemia [Category 2 & 3]	at 12-week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in 24-hour ambulatory diastolic BP from baseline to 12 weeks	at 12-week follow-up
Mean change in daytime systolic BP from baseline to 12 weeks	at 12-week follow-up
Mean change in daytime diastolic BP from baseline to 12 weeks	at 12-week follow-up
Mean change in nighttime systolic BP from baseline to 12 weeks	at 12-week follow-up
Mean change in nighttime diastolic BP from baseline to 12 weeks	at 12-week follow-up
change in diurnal variability of BP from baseline to 12 weeks	at 12-week follow-up
percent of subjects achieving the target BP	at 12-week follow-up
percent of subjects achieving the target LDL-cholesterol	at 12-week follow-up
change in serum triglyceride from baseline to 12 weeks	at 12-week follow-up
change in serum HDL-cholesterol from baseline to 12 weeks	at 12-week follow-up
change in body mass index from baseline to 12 weeks	at 12-week follow-up
change in quality of life (EuroQOL) from baseline to 12 weeks	at 12-week follow-up
change in activity score (IPAQ) from baseline to 12 weeks	at 12-week follow-up
change in smart watch-measured mean systolic BP from baseline to 12 weeks	at 12-week follow-up
change in smart watch-measured mean diastolic BP from baseline to 12 weeks	at 12-week follow-up

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 2, 2023
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): February 28, 2024

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (ACTUAL): February 3, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: smart healthcare
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Lipid Metabolism Disorders; Dyslipidemias; Chronic Disease; Hyperlipidemias
• Other Study ID Numbers: 2023-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No