HypertensionNCT07045623
Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients
A study testing centralized management and education group in people with Hypertension and Diabetes Mellitus, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
The prevalence of dyslipidemia is high among patients with hypertension and diabetes mellitus, which increases the risk of cardiovascular disease. However, many patients lack awareness and adherence to treatment and lifestyle modifications. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Dyslipidemia
- What is being tested?
- centralized management and education group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients registered in the Hanam City Hypertension and Diabetes Program
- Adults aged 30 to 80 years
- Individuals who have provided written informed consent to participate in the study
Who cannot join
- Chronic kidney disease stage 4 or higher (eGFR <30 mL/min/1.73m²)
- Patients with liver cirrhosis or severe liver disease
- Patients with a history of acute coronary syndrome within the past 6 months
- Pregnant or breastfeeding women • Individuals with psychiatric disorders that may affect study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Catholic University of Korea, ST. Vincent's Hospital.
Gyeonggi-do, Suwon-si, 16247
Sung-Ho Her, 82+031-249-7548, hhhsungho@naver.com
About this study
The prevalence of dyslipidemia is high among patients with hypertension and diabetes mellitus, which increases the risk of cardiovascular disease. However, many patients lack awareness and adherence to treatment and lifestyle modifications. Therefore, a more structured and intensive approach to management and education is required.
This study aims to implement intensive dyslipidemia management and education for patients registered at the Hanam City Hypertension and Diabetes Education Center and evaluate changes in blood lipid levels accordingly. Additionally, the study will analyze the impact of intensive education on patients' quality of life, health behaviors, and treatment adherence, ultimately contributing to the development of effective management strategies.
Read the detailed description
- Necessity of Dyslipidemia Management Education for Patients with Hypertension and Diabetes : The prevalence of dyslipidemia is high among patients with hypertension and diabetes mellitus, making it a major risk factor for cardiovascular diseases. Previous studies have demonstrated that intensive dyslipidemia management plays a crucial role in preventing cardiovascular events. However, the level of education and management provided in primary healthcare settings remains unstandardized, and there is a lack of research validating the effectiveness of structured intensive management programs. Enhancing education on dyslipidemia is not merely a therapeutic intervention but a preventive measure that can contribute to long-term health improvements in patients. Lifestyle modifications reinforced through intensive education serve as a complementary approach to pharmacological treatment, ultimately reducing healthcare costs and enabling the efficient allocation of medical resources. Therefore, this study aims to evaluate the effectiveness of intensive dyslipidemia management and education for patients with hypertension and diabetes, providing evidence-based treatment strategies.
- Objectives and Expected Outcomes :
The primary objective of this study is to assess the impact of intensive dyslipidemia education on improving blood lipid profiles in patients with hypertension and diabetes. Through this evaluation, the study seeks to contribute to the establishment of a more structured and standardized dyslipidemia management model within the existing chronic disease management system in Korea.
Additionally, this study aims to analyze the cost-benefit effect of enhanced education and examine its influence on reducing healthcare expenditures and improving long-term patient health management. Notably, dyslipidemia education has high feasibility for implementation in primary healthcare institutions and public health centers without requiring additional infrastructure, making it a highly practical intervention.
Furthermore, standardizing educational content alone is expected to yield positive effects on patient management, serving as a critical reference for future public health policy development. The findings of this study are anticipated to contribute to the revision of national dyslipidemia management guidelines and policymaking while enhancing the effectiveness of chronic disease management initiatives led by health authorities.
- Conditions
- Hypertension, Diabetes Mellitus, Dyslipidemia, Primary Prevention
- Being tested
- centralized management and education group
- Keywords
- Primary prevention, Chronic disease, Dyslipidemia
- Medical subject headings
- Hypertension, Diabetes Mellitus, Dyslipidemias, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
centralized management and education groupOther
If assigned to the test group (centralized management and education group), two instructors, one nurse and one nutritionist, will receive an hour of diabetes and high blood pressure 1:15, and will receive an hour of lipid disorder disease and impact 1:15 group education. You will receive a total of 2 hours of education, and you will receive 1 hour of lipid abnormality education conducted in 0 months through a visit in the third month. The dyslipidemia education was conducted in the form of 1:15 small group education or 1:87 group education, which was conducted in 0 months. In particular, the 1:87 form of large-scale education will be operated as a dialogue-oriented lecture that asks and answers questions, and will be conducted by doctors. And in 2 months and 4 months, education on diabetes, high blood pressure, and dyslipidemia will be shortened for 3 minutes through non-face-to-face management phone calls, not face-to-face.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care and Education Group | Experimental | Through a visit to the center in 0 months, two instructors, one nurse and one nutritionist, provide an hour of diabetes and high blood pressure 1:15 group education, and an additional hour of lipid abnormalities and effects 1:15 group education. A total of two hours of education will be conducted, and the same content of lipid abnormality education conducted in 0 months will be conducted for an hour through visits in the third month. Hyperlipidemia education is conducted in the form of 1:15 small group education with the same content conducted in 0 months or 1:87 size group education. In particular, 1:87 form of large-scale education will be operated as a dialogue-oriented lecture that asks and answers questions, and will be conducted by doctors. In addition, in two months and four months, education on diabetes, high blood pressure, and dyslipidemia will be conducted briefly for three minutes through non-face-to-face management phone calls, not visits. Receives: Other: centralized management and education group |
| Standard Care and Education Group | No intervention | For only 0 months, two instructors, one nurse and one nutritionist, will provide 1 hour of diabetes and high blood pressure 1:15 group education, which corresponds to standard management education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
Measured: at baseline (pre-intervention) and at 6 months (after the intervention)
Secondary outcomes (4)
Change from Baseline in systolic blood pressure, diastolic blood pressure at 6 months
Change from Baseline in systolic blood pressure, diastolic blood pressure at 6 months
Measured: at baseline (pre-intervention) and at 6 months (after the intervention)
Change from Baseline in HbA1c level at 6 months
Change from Baseline in HbA1c level at 6 months
Measured: at baseline (pre-intervention) and at 6 months (after the intervention)
Change from Baseline in Quality of Life assessed by SF-36 at 6 months
Change from Baseline in Quality of Life assessed by SF-36 at 6 months
Measured: at baseline (pre-intervention) and at 6 months
Change from Baseline in structured questionnaire assessing lifestyle (Physical activity, Dietary habits, Alcohol consumption, Smoking status)
Physical activity : Ordinal categorical variable (Number of days in the past week the participant exercised for ≥30 minutes to promote health (e.g., walking, aerobic, yoga, cycling, swimming)) Dietary habits (1) : Binary categorical variable (In the past month, did you eat breakfast on average ≥5 times per week?) Dietary habits (2) : Binary categorical variable (In the past month, did you consume processed foods (e.g., bread, chips, instant noodles, mix coffee, soda, sugary beverages) ≥ once per week on average?) Alcohol consumption : Ordinal categorical variable (Do you currently drink alcohol? -> 1 = Frequently, 2 = Rarely, 3 = Never) Smoking status : Categorical variable (Do you currently smoke? -> 1 = Yes, 2 = No, 3 = Former smoker (Stopped))
Measured: at baseline (pre-intervention) and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 348 participants will be enrolled, with 174 assigned to the intensive care and education group and 174 to the conventional care and education group.
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Hanam City Center for Hypertension and Diabetes Registration, Korean Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045623
- Sponsor's protocol ID
- VC25OISI0048
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients
- ClinicalTrials.gov ID
- NCT07045623
- Acronym / sponsor ID
- VC25OISI0048
- Conditions
- Hypertension, Diabetes Mellitus, Dyslipidemia, Primary Prevention
- Keywords
- Primary prevention, Chronic disease, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Collaborators
- Hanam City Center for Hypertension and Diabetes Registration, Korean Center for Disease Control and Prevention
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
The prevalence of dyslipidemia is high among patients with hypertension and diabetes mellitus, which increases the risk of cardiovascular disease. However, many patients lack awareness and adherence to treatment and lifestyle modifications. Therefore, a more structured and intensive approach to management and education is required.
This study aims to implement intensive dyslipidemia management and education for patients registered at the Hanam City Hypertension and Diabetes Education Center and evaluate changes in blood lipid levels accordingly. Additionally, the study will analyze the impact of intensive education on patients' quality of life, health behaviors, and treatment adherence, ultimately contributing to the development of effective management strategies.
Detailed description
- Necessity of Dyslipidemia Management Education for Patients with Hypertension and Diabetes : The prevalence of dyslipidemia is high among patients with hypertension and diabetes mellitus, making it a major risk factor for cardiovascular diseases. Previous studies have demonstrated that intensive dyslipidemia management plays a crucial role in preventing cardiovascular events. However, the level of education and management provided in primary healthcare settings remains unstandardized, and there is a lack of research validating the effectiveness of structured intensive management programs. Enhancing education on dyslipidemia is not merely a therapeutic intervention but a preventive measure that can contribute to long-term health improvements in patients. Lifestyle modifications reinforced through intensive education serve as a complementary approach to pharmacological treatment, ultimately reducing healthcare costs and enabling the efficient allocation of medical resources. Therefore, this study aims to evaluate the effectiveness of intensive dyslipidemia management and education for patients with hypertension and diabetes, providing evidence-based treatment strategies.
- Objectives and Expected Outcomes :
The primary objective of this study is to assess the impact of intensive dyslipidemia education on improving blood lipid profiles in patients with hypertension and diabetes. Through this evaluation, the study seeks to contribute to the establishment of a more structured and standardized dyslipidemia management model within the existing chronic disease management system in Korea.
Additionally, this study aims to analyze the cost-benefit effect of enhanced education and examine its influence on reducing healthcare expenditures and improving long-term patient health management. Notably, dyslipidemia education has high feasibility for implementation in primary healthcare institutions and public health centers without requiring additional infrastructure, making it a highly practical intervention.
Furthermore, standardizing educational content alone is expected to yield positive effects on patient management, serving as a critical reference for future public health policy development. The findings of this study are anticipated to contribute to the revision of national dyslipidemia management guidelines and policymaking while enhancing the effectiveness of chronic disease management initiatives led by health authorities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 348 participants will be enrolled, with 174 assigned to the intensive care and education group and 174 to the conventional care and education group.
| Arm | Type | Receives |
|---|---|---|
| Intensive Care and Education Group | Experimental | Other: centralized management and education groupThrough a visit to the center in 0 months, two instructors, one nurse and one nutritionist, provide an hour of diabetes and high blood pressure 1:15 group education, and an additional hour of lipid abnormalities and effects 1:15 group education. A total of two hours of education will be conducted, and the same content of lipid abnormality education conducted in 0 months will be conducted for an hour through visits in the third month. Hyperlipidemia education is conducted in the form of 1:15 small group education with the same content conducted in 0 months or 1:87 size group education. In particular, 1:87 form of large-scale education will be operated as a dialogue-oriented lecture that asks and answers questions, and will be conducted by doctors. In addition, in two months and four months, education on diabetes, high blood pressure, and dyslipidemia will be conducted briefly for three minutes through non-face-to-face management phone calls, not visits. |
| Standard Care and Education Group | No intervention | –For only 0 months, two instructors, one nurse and one nutritionist, will provide 1 hour of diabetes and high blood pressure 1:15 group education, which corresponds to standard management education. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients registered in the Hanam City Hypertension and Diabetes Program
- Adults aged 30 to 80 years
- Individuals who have provided written informed consent to participate in the study
Key exclusion criteria (4 listed)
- Chronic kidney disease stage 4 or higher (eGFR <30 mL/min/1.73m²)
- Patients with liver cirrhosis or severe liver disease
- Patients with a history of acute coronary syndrome within the past 6 months
- Pregnant or breastfeeding women • Individuals with psychiatric disorders that may affect study participation
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 |
|---|---|---|
| centralized management and education groupIf assigned to the test group (centralized management and education group), two instructors, one nurse and one nutritionist, will receive an hour of diabetes and high blood pressure 1:15, and will receive an hour of lipid disorder disease and impact 1:15 group education. You will receive a total of 2 hours of education, and you will receive 1 hour of lipid abnormality education conducted in 0 months through a visit in the third month. The dyslipidemia education was conducted in the form of 1:15 small group education or 1:87 group education, which was conducted in 0 months. In particular, the 1:87 form of large-scale education will be operated as a dialogue-oriented lecture that asks and answers questions, and will be conducted by doctors. And in 2 months and 4 months, education on diabetes, high blood pressure, and dyslipidemia will be shortened for 3 minutes through non-face-to-face management phone calls, not face-to-face. | Other | Intensive Care and Education Group |
Primary outcome
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
Time frame: at baseline (pre-intervention) and at 6 months (after the intervention)
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
4 secondary outcomes
Change from Baseline in systolic blood pressure, diastolic blood pressure at 6 months
Time frame: at baseline (pre-intervention) and at 6 months (after the intervention)
Change from Baseline in HbA1c level at 6 months
Time frame: at baseline (pre-intervention) and at 6 months (after the intervention)
Change from Baseline in Quality of Life assessed by SF-36 at 6 months
Time frame: at baseline (pre-intervention) and at 6 months
Change from Baseline in structured questionnaire assessing lifestyle (Physical activity, Dietary habits, Alcohol consumption, Smoking status)
Time frame: at baseline (pre-intervention) and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing centralized management and education group in people with Hypertension and Diabetes Mellitus, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Ho Her (+82312598397, hhhsungho@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months (time frame: at baseline (pre-intervention) and at 6 months (after the intervention)). 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 1 Jul 2025.