Coronary Artery DiseaseNCT05939297
Turkish Adaptation of Heart Health Self-efficacy and Self-Management Scale
An observational study of Coronary Artery Disease, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The importance of lifestyle changes to control risk factors in the prevention, treatment and management of coronary heart disease (CHD), a major health problem, has been emphasised. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Heart Health Self-efficacy and Self-Management Scale, Self-Care Management Scale in chronic diseases and general self-efficacy scale
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 15 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer who had been diagnosed coronary heart disease for at least 6 months
Who may be able to join
- Being diagnosed with coronary heart disease for at least 6 months
- Speaking Turkish
- to be able to read and write
- Being over 18 years old
- volunteering to participate in the study
Who cannot join
- Having a serious psychiatric illness such as panic disorder or major depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Turkish Adaptation, Validity and Reliability of the Heart Health Self-Efficacy and Self-Management Scale
The importance of lifestyle changes to control risk factors in the prevention, treatment and management of coronary heart disease (CHD), a major health problem, has been emphasised. In addition, physical, social, psychological and occupational limitations arising from the disease negatively affect the quality of life and self-efficacy perceptions of individuals, making it difficult to comply with treatment and disease management. There are general self-efficacy and self-management scales for which Turkish validity and reliability studies have been conducted previously. However, these scales are not specific to coronary heart disease patients and evaluate either only self-efficacy or only self-management. The aim of this study was to adapt the Heart Health Self-efficacy and Self-Management Scale (HH-SESM) into Turkish and to investigate its validity and reliability in patients with coronary heart disease. The study is conducted in Cardiology outpatient clinics of Karaman Training and Research Hospital. Before the study, the purpose and content of the study will be explained to the participants and an informed consent form will be obtained from the participants. Since the sample size in validity and reliability studies should be at least 10 times the total number of scale items, at least 120 individuals will be included in the study as the number of items x number of options (12 x 10 = 120). Detailed medical history and sociodemographic information (age, gender, height, weight, body mass index, disease duration (months), occupation, daily working hours, educational status, sports/exercise habits) will be recorded. In order to measure self-management and self-efficacy levels, patients will be administered the HH-SESM, Self-care management in chronic diseases scale- Self-care subgroup questions and General self-efficacy scales.
- Conditions
- Coronary Artery Disease
- Being tested
- Heart Health Self-efficacy and Self-Management Scale, Self-Care Management Scale in chronic diseases, general self-efficacy scale
- Keywords
- coronary artery disease, validitiy, reliability, Self efficacy, Self Management, Heart Health
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Health Self-efficacy and Self-Management ScaleOther
In order to measure the self-management and self-efficacy levels of the individuals, patients will be administered the Heart Health Self-efficacy and Self-Management Scale.
Self-Care Management Scale in chronic diseasesOther
For the external construct validity statistical method, the self-management level of the individuals will also be determined with the Self-Care Management in Chronic Diseases Scale, which has been previously validated and reliable in Turkish.
general self-efficacy scaleOther
For the external construct validity statistical method, the self-efficacy level of the individuals will also be determined with the general self-efficacy scale, which has been previously validated and reliable in Turkish.
| Study group | Role | What they receive |
|---|---|---|
| people with coronary heart disease | In order to measure the self-management and self-efficacy levels of the patients,Heart Health Self-efficacy and Self-Management Scale , Self-Care Management Scale in Chronic Diseases, general self-efficacy scales will be applied to the patients. Receives: Other: Heart Health Self-efficacy and Self-Management Scale; Other: Self-Care Management Scale in chronic diseases; Other: general self-efficacy scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity and reliability of Turkish Heart Health Self-efficacy and Self-Management Scale
It will be applied to the patients as a questionnaire in order to make the Turkish validity and reliability of the Heart Health Self-efficacy and Self-Management Scale. Scores ≥36 can be interpreted as high self-efficacy and high self-management. The scale consists of 12 items and is scored using a 4-point Likert system. But since there is also an invalid answer option, people can get a minimum score of 0 and a maximum score of 48. Scores ≥36 can be interpreted as high self-efficacy and high self-management. Scores between 24 - 35 can be interpreted as adequate self-efficacy and adequate self-management. Scores ≤24 can be interpreted as low self-efficacy and low self-management.
Measured: within 24 hours of admission
Secondary outcomes (2)
Self-Care Management Scale in chronic diseases
For the external construct validity statistical method, the self-management level of the individuals will be determined with the Self-Care Management in Chronic Diseases Scale, which has been previously validated and reliable in Turkish. The scale consists of 20 items. The scale is analysed over the total score. 5-point Likert system is used in scoring, with 1 point for strongly disagree and 5 points for strongly agree.
Individuals can get a maximum score of 100 and a minimum score of 20. A high score indicates high general self-efficacy; a low score indicates low self-efficacy.
Measured: within 24 hours of admission
General self-efficacy scale
For the external construct validity statistical method, the self-efficacy level of the individuals will be determined with the general self-efficacy scale, which has been previously validated and reliable in Turkish. The scale consists of 10 items. The scale is analysed over the total score. Points are given to the items according to the answers.
Completely wrong = 1 point Somewhat correct = 2 points Moderately correct = 3 points Completely correct = 4 points
Individuals can get a maximum score of 40 and a minimum score of 10. A high score indicates high general self-efficacy; a low score indicates low self-efficacy.
Measured: within 24 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start15 Jun 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Emine Tunç Süygün, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939297
- Sponsor's protocol ID
- KMU-TUNCSUYGUN-002
- Status last verified
- Mar 2024
- First submitted
- 21 Jun 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tunc Suygun E, Vardar Yagli N, Suygun H, Saglam M. Validity and reliability of the Turkish translation of the heart health self-efficacy and self-management scale in patients with chronic heart disease. BMC Psychol. 2025 Nov 3;13(1):1210. doi: 10.1186/s40359-025-03539-6.
PubMed 41185050
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Adaptation, Validity and Reliability of the Heart Health Self-Efficacy and Self-Management Scale
- ClinicalTrials.gov ID
- NCT05939297
- Acronym / sponsor ID
- KMU-TUNCSUYGUN-002
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, validitiy, reliability, Self efficacy, Self Management, Heart Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 11 Jul 2023 (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.
The importance of lifestyle changes to control risk factors in the prevention, treatment and management of coronary heart disease (CHD), a major health problem, has been emphasised. In addition, physical, social, psychological and occupational limitations arising from the disease negatively affect the quality of life and self-efficacy perceptions of individuals, making it difficult to comply with treatment and disease management. There are general self-efficacy and self-management scales for which Turkish validity and reliability studies have been conducted previously. However, these scales are not specific to coronary heart disease patients and evaluate either only self-efficacy or only self-management. The aim of this study was to adapt the Heart Health Self-efficacy and Self-Management Scale (HH-SESM) into Turkish and to investigate its validity and reliability in patients with coronary heart disease. The study is conducted in Cardiology outpatient clinics of Karaman Training and Research Hospital. Before the study, the purpose and content of the study will be explained to the participants and an informed consent form will be obtained from the participants. Since the sample size in validity and reliability studies should be at least 10 times the total number of scale items, at least 120 individuals will be included in the study as the number of items x number of options (12 x 10 = 120). Detailed medical history and sociodemographic information (age, gender, height, weight, body mass index, disease duration (months), occupation, daily working hours, educational status, sports/exercise habits) will be recorded. In order to measure self-management and self-efficacy levels, patients will be administered the HH-SESM, Self-care management in chronic diseases scale- Self-care subgroup questions and General self-efficacy scales.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| people with coronary heart disease | – | Other: Heart Health Self-efficacy and Self-Management Scale, Other: Self-Care Management Scale in chronic diseases, Other: general self-efficacy scaleIn order to measure the self-management and self-efficacy levels of the patients,Heart Health Self-efficacy and Self-Management Scale , Self-Care Management Scale in Chronic Diseases, general self-efficacy scales will be applied to the patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer who had been diagnosed coronary heart disease for at least 6 months
Key inclusion criteria (5 listed)
- Being diagnosed with coronary heart disease for at least 6 months
- Speaking Turkish
- to be able to read and write
- Being over 18 years old
- volunteering to participate in the study
Key exclusion criteria (1 listed)
- Having a serious psychiatric illness such as panic disorder or major depression
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 |
|---|---|---|
| Heart Health Self-efficacy and Self-Management ScaleIn order to measure the self-management and self-efficacy levels of the individuals, patients will be administered the Heart Health Self-efficacy and Self-Management Scale. | Other | people with coronary heart disease |
| Self-Care Management Scale in chronic diseasesFor the external construct validity statistical method, the self-management level of the individuals will also be determined with the Self-Care Management in Chronic Diseases Scale, which has been previously validated and reliable in Turkish. | Other | people with coronary heart disease |
| general self-efficacy scaleFor the external construct validity statistical method, the self-efficacy level of the individuals will also be determined with the general self-efficacy scale, which has been previously validated and reliable in Turkish. | Other | people with coronary heart disease |
Primary outcome
validity and reliability of Turkish Heart Health Self-efficacy and Self-Management Scale
Time frame: within 24 hours of admission
It will be applied to the patients as a questionnaire in order to make the Turkish validity and reliability of the Heart Health Self-efficacy and Self-Management Scale. Scores ≥36 can be interpreted as high self-efficacy and high self-management. The scale consists of 12 items and is scored using a 4-point Likert system. But since there is also an invalid answer option, people can get a minimum score of 0 and a maximum score of 48. Scores ≥36 can be interpreted as high self-efficacy and high self-management. Scores between 24 - 35 can be interpreted as adequate self-efficacy and adequate self-management. Scores ≤24 can be interpreted as low self-efficacy and low self-management.
2 secondary outcomes
Self-Care Management Scale in chronic diseases
Time frame: within 24 hours of admission
General self-efficacy scale
Time frame: within 24 hours of admission
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 29 Mar 2024.
- Derived from this study: PubMed 41185050Tunc Suygun E, Vardar Yagli N, Suygun H, Saglam M. Validity and reliability of the Turkish translation of the heart health self-efficacy and self-management scale in patients with chronic heart disease. BMC Psychol. 2025 Nov 3;13(1):1210. doi: 10.1186/s40359-025-03539-6.
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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?
An observational study of Coronary Artery Disease, run by Karamanoğlu Mehmetbey 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 5 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 29 Mar 2024. 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?
validity and reliability of Turkish Heart Health Self-efficacy and Self-Management Scale (time frame: within 24 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05939297, which also lists 1 linked publication.
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 29 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.