Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients

Saint Vincent's Hospital, Korea

Status: Enrolling

Conditions: Hypertension; Primary Prevention; Diabetes Mellitus; Dyslipidemia

Treatments: Other: centralized management and education group

Study type: Interventional

Funder types: Other

Identifiers

NCT07045623

VC25OISI0048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 348 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

Intensive Care and Education Group

Experimental group

Description:

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.

Treatment:

Other: centralized management and education group

Standard Care and Education Group

No Intervention group

Description:

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.