Mobile Application for Cardiovascular Risk Treatment

Hypertension Clinical Trial

— iSMART-CV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05712070
• Other study ID #: 2023-0003
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: January 2023
• Source: Asan Medical Center
• Contact: Soo-Jin Kang, M.D.
• Phone: +82230103157
• Email: sjkang3157[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: February 28, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 54 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• Hyperlipidemias
• Hypertension
• Lifestyle Risk Reduction

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

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