Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intensive Care and Education Group
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.
干预措施: centralized management and education group (Other)
Standard Care and Education Group
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.
结局指标
主要结局
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
时间窗: 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
Change from Baseline in Total cholesterol, Triglyceride, HDL-cholesterol, LDL-cholesterol levels at 6 months
时间窗: 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
次要结局
- 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 HbA1c level 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(at baseline (pre-intervention) and at 6 months (after the intervention))
- Change from Baseline in HbA1c level at 6 months(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(at baseline (pre-intervention) and 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)