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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05939297
Other study ID # KMU-TUNCSUYGUN-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2022
Est. completion date December 15, 2023

Study information

Verified date March 2024
Source Karamanoglu Mehmetbey University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having a serious psychiatric illness such as panic disorder or major depression

Study Design


Intervention

Other:
Heart Health Self-efficacy and Self-Management Scale
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 diseases
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 scale
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.

Locations

Country Name City State
Turkey Karamanoglu Mehmetbey University Karaman

Sponsors (2)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within 24 hours of admission
Secondary 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.
within 24 hours of admission
Secondary 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.
within 24 hours of admission
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