Cardiovascular Diseases RiskNCT07047950
Effect of Health Belief Model-Based Education
A study testing Individual Education and Counseling Program in people with Cardiovascular Diseases Risk and Health Belief Model, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases Risk, Health Belief Model, Nursing
- What is being tested?
- Individual Education and Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being under the age of 65
- Having normal cognitive functioning
- Having no communication difficulties
Who cannot join
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases Risk, Health Belief Model, Nursing
- Being tested
- Individual Education and Counseling Program
- Keywords
- Cardiovascular Diseases, Health Belief Model
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Education and Counseling ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Individual Education and Counseling Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 01 January 2023 to 01 Februrary 2023 (4 weeks)
Secondary outcomes (3)
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. 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.
Measured: From 15 June 2023 to 15 July 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.
Measured: From 15 June 2023 to 15 July 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.
Measured: From 15 June 2023 to 15 July 2023 (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental design with a pre-test and post-test approach was employed.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Faruk Yigit, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047950
- Sponsor's protocol ID
- ınonu university
- Status last verified
- Jun 2025
- First submitted
- 21 Apr 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Education and Counseling Program on Coronary Heart Disease Risk
- ClinicalTrials.gov ID
- NCT07047950
- Acronym / sponsor ID
- ınonu university
- Conditions
- Cardiovascular Diseases Risk, Health Belief Model, Nursing
- Keywords
- Cardiovascular Diseases, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A quasi-experimental design with a pre-test and post-test approach was employed.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention applied |
| Experimental group | Experimental | Behavioral: Individual Education and Counseling Program* 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being under the age of 65
- Having normal cognitive functioning
- Having no communication difficulties
Key exclusion criteria (1 listed)
- Not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Education and Counseling ProgramThe 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 | Behavioural | Experimental group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Knowledge Level of Cardiovascular Disease Risk Factors Scale
Time frame: 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)
Framingham Risk Score
Time frame: From 15 June 2023 to 15 July 2023 (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Education and Counseling Program in people with Cardiovascular Diseases Risk and Health Belief Model, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Level of Cardiovascular Disease Risk Factors Scale (time frame: From 01 January 2023 to 01 Februrary 2023 (4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.