Effect of Health Belief Model-Based Education

June 27, 2025 updated by: Muhammet Faruk Yigit, Yuzuncu Yıl University

The Effect of Health Belief Model-Based Education and Counseling Program on Coronary Heart Disease Risk

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 healthy diet.

Participants in the educational sessions received a booklet entitled "Health Belief Model Approach to Prevent CHD" as a reminder tool. This booklet contained the same information as the presentation.

The education was given to the intervention group immediately after the collection of the pre-test data. The control group received no intervention. The post-test data were collected six months after the pre-test. After the post-test, participants in the control group also received the educational booklet.

The care approach, based on the HBM, included several interventions aimed at increasing participants' awareness of CHD. To increase the perception of susceptibility, participants were informed about the definition, symptoms, incidence and risk factors of CHD, thereby increasing their sensitivity to the issue. To increase perceptions of severity, the health, social and economic problems caused by CHD were explained in detail. Perceptions of benefits were enhanced by emphasising the benefits of prevention in the lives of the participants.

In terms of barriers, potential obstacles to adopting health-promoting behaviours to prevent CHD were explained in detail. Health motivation was supported by providing education and counselling services to help participants overcome these barriers. Finally, in the self-efficacy dimension, participants were encouraged to share their thoughts about prevention methods, which helped to build their confidence. This approach aimed to empower participants to be more aware and effective in preventing CHD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65100
        • Dursun Odabaş Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not volunteering to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
No intervention applied
Experimental: Experimental group
  • 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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge Level of Cardiovascular Disease Risk Factors Scale
Time Frame: From 01 January 2023 to 01 Februrary 2023 (4 weeks)
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
Time Frame: From 01 January 2023 to 01 Februrary 2023 (4 weeks)
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
Time Frame: From 01 January 2023 to 01 Februrary 2023 (4 weeks)
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
Time Frame: From 01 January 2023 to 01 Februrary 2023 (4 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge Level of Cardiovascular Disease Risk Factors Scale
Time Frame: From 15 June 2023 to 15 July 2023 (4 weeks)
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. Participants respond to items with "Yes," "No," or "I don't know," and correct responses are scored as 1 point. It is important to note that, in the interest of scientific rigour, any responses marked as "I don't know" are categorised as incorrect during the evaluation process, thus ensuring the integrity of the data collected.
From 15 June 2023 to 15 July 2023 (4 weeks)
Perception of Heart Disease Risk Scale
Time Frame: From 15 June 2023 to 15 July 2023 (4 weeks)
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 15 June 2023 to 15 July 2023 (4 weeks)
Framingham Risk Score
Time Frame: From 15 June 2023 to 15 July 2023 (4 weeks)
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 15 June 2023 to 15 July 2023 (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ınonu university

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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