NCT05939297

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

June 21, 2023

Last Update Submit

March 28, 2024

Conditions

Keywords

coronary artery diseasevaliditiyreliabilitySelf efficacySelf ManagementHeart Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Self-Care Management Scale in chronic diseases

    within 24 hours of admission

  • General self-efficacy scale

    within 24 hours of admission

Study Arms (1)

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.

Other: Heart Health Self-efficacy and Self-Management ScaleOther: Self-Care Management Scale in chronic diseasesOther: general self-efficacy scale

Interventions

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.

people with coronary heart disease

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.

people with coronary heart disease

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.

people with coronary heart disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteer who had been diagnosed coronary heart disease for at least 6 months

You may qualify if:

  • 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

You may not qualify if:

  • Having a serious psychiatric illness such as panic disorder or major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 11, 2023

Study Start

June 15, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations