Diabetes Mellitus, Dyslipidemia, Hypertension, Primary Prevention
Conditions
Keywords
Primary prevention, Chronic disease, Dyslipidemia
Brief 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. 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
1. 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. 2. 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.
Interventions
OTHERcentralized management and education group
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.
Sponsors
Hanam City Center for Hypertension and Diabetes Registration
Korean Center for Disease Control and Prevention
Saint Vincent's Hospital, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in systolic blood pressure, diastolic blood pressure at 6 months | at baseline (pre-intervention) and at 6 months (after the intervention) | Change from Baseline in systolic blood pressure, diastolic blood pressure at 6 months |
| Change from Baseline in HbA1c level at 6 months | at baseline (pre-intervention) and at 6 months (after the intervention) | Change from Baseline in HbA1c level at 6 months |
| Change from Baseline in Quality of Life assessed by SF-36 at 6 months | at baseline (pre-intervention) and at 6 months | Change from Baseline in Quality of Life assessed by SF-36 at 6 months |
| Change from Baseline in structured questionnaire assessing lifestyle (Physical activity, Dietary habits, Alcohol consumption, Smoking status) | at baseline (pre-intervention) and at 6 months | 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)) |
Countries
South Korea
Contacts
Primary ContactSung-Ho Her
Outcome results
None listed