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

NCT07045623 | Recruiting

• 1 other identifier: VC25OISI0048
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus; Dyslipidemia; Primary Prevention

Keywords

Primary prevention; Chronic disease; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

Study Arms (2)

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.

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.

Interventions

centralized management and education group OTHER

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.

Intensive Care and Education Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead
• Hanam City Center for Hypertension and Diabetes Registration: collaborator
• Korean Center for Disease Control and Prevention: collaborator

Study Sites (1)

Catholic University of Korea, ST. Vincent's Hospital.

Gyeonggi-do, Suwon-si, 16247, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Dyslipidemias; Chronic Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sung-Ho Her

CONTACT

+82312598397; hhhsungho@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: July 1, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-05

Locations

KR (1)