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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorSaint Vincent's Hospital, Korea

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • centralized management and education group

    Other intervention

    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.

Treatment groups

348 Participants
are divided into 2 treatment groups
Group A: Intensive Care and Education GroupExperimental treatment 1 intervention
Group B: Standard Care and Education GroupNo intervention 0 interventions

Trial outcomes

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

Time frame
at baseline (pre-intervention) and at 6 months (after the intervention)

Secondary outcomes

1

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

Time frame
at baseline (pre-intervention) and at 6 months (after the intervention)
2

Change from Baseline in HbA1c level at 6 months

Change from Baseline in HbA1c level at 6 months

Time frame
at baseline (pre-intervention) and at 6 months (after the intervention)
3

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

Time frame
at baseline (pre-intervention) and at 6 months
4

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))

Time frame
at baseline (pre-intervention) and at 6 months

Other outcomes

Sponsors and contacts

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Saint Vincent's Hospital, Korea

Lead sponsor

Hanam City Center for Hypertension and Diabetes Registration

Collaborator

Korean Center for Disease Control and Prevention

Collaborator