About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
centralized management and education group
Other interventionIf 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Change from Baseline in HbA1c level at 6 months
Change from Baseline in HbA1c level at 6 months
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
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))
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Saint Vincent's Hospital, Korea
Lead sponsor
Hanam City Center for Hypertension and Diabetes Registration
Collaborator
Korean Center for Disease Control and Prevention
Collaborator