HypertensioniSMART-CVNCT05712070
Mobile Application for Cardiovascular Risk Treatment
A study testing App-guided lifestyle modification and A book-based self-education of lifestyle modification in people with Hypertension and Hyperlipidemias, run by Asan Medical Center.
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. Read more about this study
- Who is it for?
- Ages 20 to 54 years
- Conditions the study is for
- Hypertension, Hyperlipidemias, Chronic Disease
- What is being tested?
- App-guided lifestyle modification and A book-based self-education of lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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].
- Being tested
- App-guided lifestyle modification, A book-based self-education of lifestyle modification
- Keywords
- smart healthcare
- Medical subject headings
- Hypertension, Hyperlipidemias, Chronic Disease, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-guided lifestyle modificationBehavioural
Smart watch and smartphone application-based life style modification for 12 weeks
A book-based self-education of lifestyle modificationBehavioural
A take-home book-based self-education for lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| smart group | Experimental | Smartphone App-based healthcare Receives: Behavioral: App-guided lifestyle modification |
| control group | Active comparator | a book-based self-education Receives: Behavioral: A book-based self-education of lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in 24-hour ambulatory systolic BP from baseline to 12 weeks
in patients with hypertension [Category 1 \& 3]
Measured: at 12-week follow-up
Mean change in serum LDL-cholesterol level from baseline to 12 weeks
in patients with hyperlipidemia [Category 2 \& 3]
Measured: at 12-week follow-up
Secondary outcomes (15)
Mean change in 24-hour ambulatory diastolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
Mean change in daytime systolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
Mean change in daytime diastolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
Mean change in nighttime systolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
Mean change in nighttime diastolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
change in diurnal variability of BP from baseline to 12 weeks
Measured: at 12-week follow-up
percent of subjects achieving the target BP
Measured: at 12-week follow-up
percent of subjects achieving the target LDL-cholesterol
Measured: at 12-week follow-up
change in serum triglyceride from baseline to 12 weeks
Measured: at 12-week follow-up
change in serum HDL-cholesterol from baseline to 12 weeks
Measured: at 12-week follow-up
change in body mass index from baseline to 12 weeks
Measured: at 12-week follow-up
change in quality of life (EuroQOL) from baseline to 12 weeks
Measured: at 12-week follow-up
change in activity score (IPAQ) from baseline to 12 weeks
Measured: at 12-week follow-up
change in smart watch-measured mean systolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
change in smart watch-measured mean diastolic BP from baseline to 12 weeks
Measured: at 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start2 Mar 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Jin Kang, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712070
- Sponsor's protocol ID
- 2023-0003
- Acronym
- iSMART-CV
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smart Watch Mobile Application on Risk Treatment of CardioVascular Disease
- ClinicalTrials.gov ID
- NCT05712070
- Acronym / sponsor ID
- iSMART-CV / 2023-0003
- Keywords
- smart healthcare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smart group | Experimental | Behavioral: App-guided lifestyle modificationSmartphone App-based healthcare |
| control group | Active comparator | Behavioral: A book-based self-education of lifestyle modificationa book-based self-education |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-guided lifestyle modificationSmart watch and smartphone application-based life style modification for 12 weeks | Behavioural | smart group |
| A book-based self-education of lifestyle modificationA take-home book-based self-education for lifestyle modification | Behavioural | control group |
Primary outcome
Mean change in 24-hour ambulatory systolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
in patients with hypertension [Category 1 \& 3]
Mean change in serum LDL-cholesterol level from baseline to 12 weeks
Time frame: at 12-week follow-up
in patients with hyperlipidemia [Category 2 \& 3]
15 secondary outcomes
Mean change in 24-hour ambulatory diastolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
Mean change in daytime systolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
Mean change in daytime diastolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
Mean change in nighttime systolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
Mean change in nighttime diastolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
change in diurnal variability of BP from baseline to 12 weeks
Time frame: at 12-week follow-up
percent of subjects achieving the target BP
Time frame: at 12-week follow-up
percent of subjects achieving the target LDL-cholesterol
Time frame: at 12-week follow-up
change in serum triglyceride from baseline to 12 weeks
Time frame: at 12-week follow-up
change in serum HDL-cholesterol from baseline to 12 weeks
Time frame: at 12-week follow-up
change in body mass index from baseline to 12 weeks
Time frame: at 12-week follow-up
change in quality of life (EuroQOL) from baseline to 12 weeks
Time frame: at 12-week follow-up
change in activity score (IPAQ) from baseline to 12 weeks
Time frame: at 12-week follow-up
change in smart watch-measured mean systolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
change in smart watch-measured mean diastolic BP from baseline to 12 weeks
Time frame: at 12-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing App-guided lifestyle modification and A book-based self-education of lifestyle modification in people with Hypertension and Hyperlipidemias, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo-Jin Kang, M.D. (+82230103157, sjkang3157@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in 24-hour ambulatory systolic BP from baseline to 12 weeks (time frame: at 12-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.