NCT07047950

Brief Summary

Aim: This study aimed to determine the impact of an education and counseling program based on the health belief model on coronary heart disease risk factors knowledge level, risk perception of heart disease, and Framingham risk scores. Background: Coronary heart disease remains a leading cause of morbidity and mortality worldwide, and effective prevention strategies are critical. The health belief model provides a theoretical framework for understanding and influencing health behaviors. A quasi-experimental design with a pre-test and post-test approach was employed. Methods: Data were collected using the Descriptive Characteristics Form, the Cardiovascular Disease Risk Factors Knowledge Level Scale, and the Heart Disease Risk Perception Scale. Additionally, Framingham risk scores were calculated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

April 21, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

Cardiovascular Diseases, Health Belief Model

Outcome Measures

Primary Outcomes (4)

  • Knowledge Level of Cardiovascular Disease Risk Factors Scale

    The Knowledge Level of Cardiovascular Disease Risk Factors Scale (KL-CDRFS) was developed and validated by Arıkan et al. in 2009. Notably, it is the inaugural scale in Turkey to have been both validated and proven reliable for the purpose of assessing knowledge levels concerning cardiovascular disease risk factors (Cronbach's alpha: 0.768). The scale comprises 28 items, and evaluation is based on the total score obtained.

    From 01 January 2023 to 01 Februrary 2023 (4 weeks)

  • Demographic Information Form

    The form comprises 17 questions with the objective of gathering information about patients' age, gender, education level, employment status, presence of chronic diseases, medication use, marital status, family history of heart disease, prior knowledge about heart diseases, information on prevention of heart diseases, smoking status, systolic blood pressure, diastolic blood pressure, HDL cholesterol, LDL cholesterol, fasting blood glucose levels, and Framingham risk scores.

    From 01 January 2023 to 01 Februrary 2023 (4 weeks)

  • Perception of Heart Disease Risk Scale

    The Perception of Heart Disease Risk Scale (PHDRS) was developed in 2008 by Ammouri and Neuberger with the objective of determining individuals' perceived risk of developing heart disease. A study was conducted in 2016 by Toptaner and Yıldız to ascertain the scale's validity and reliability in the Turkish population. The scale is composed of 20 items and three sub-dimensions, and utilises a 4-point Likert scale.

    From 01 January 2023 to 01 Februrary 2023 (4 weeks)

  • Framingham Risk Score

    The Framingham Risk Score is a widely used and reliable method of estimating an individual's 10-year risk of developing CHD. The calculation takes into account six risk factors: gender, age, LDL cholesterol, HDL cholesterol, diabetes, blood pressure and smoking status. Based on these values and categories, scores are determined and the corresponding 10-year risk probability is calculated. A score of less than 10% indicates low risk, 10-20% indicates moderate risk, and more than 20% indicates high risk.

    From 01 January 2023 to 01 Februrary 2023 (4 weeks)

Secondary Outcomes (3)

  • Knowledge Level of Cardiovascular Disease Risk Factors Scale

    From 15 June 2023 to 15 July 2023 (4 weeks)

  • Perception of Heart Disease Risk Scale

    From 15 June 2023 to 15 July 2023 (4 weeks)

  • Framingham Risk Score

    From 15 June 2023 to 15 July 2023 (4 weeks)

Study Arms (2)

Control group

NO INTERVENTION

No intervention applied

Experimental group

EXPERIMENTAL

* Implementation of the HBM Based Individual Education and Counseling Program for the Prevention of CHD * Phone calls conducted in the 2nd and 4th months after education. * Educational booklet distributed

Behavioral: Individual Education and Counseling Program

Interventions

The educational programme entitled "HBM Approach to Prevent CHD" was designed by the researcher and delivered as a presentation. The educational sessions were conducted face-to-face at the Cardiology Outpatient Clinic of Van Yüzüncü Yıl University Dursun Odabaş Medical Center and lasted approximately 35-45 minutes. In addition, follow-up telephone calls were made to individuals in the intervention group twice at two-month intervals. The content of the educational programme was developed based on a comprehensive literature review using resources from the Turkish Society of Cardiology, the WHO, the Ministry of Health, the Turkish Public Health Institution, evidence-based research and previous studies. The programme covered topics such as the definition of CHD, risk factors, treatment, complications, perceived susceptibility and severity of CHD, perceived benefits, barriers and strategies to overcome them, self-efficacy, and rules for engaging in physical activity and maintaining a health

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being under the age of 65
  • Having normal cognitive functioning
  • Having no communication difficulties

You may not qualify if:

  • Not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dursun Odabaş Medicine Center

Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A quasi-experimental design with a pre-test and post-test approach was employed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

April 21, 2025

First Posted

July 2, 2025

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

August 7, 2023

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations