The Turkish Validity-Reliability Study of the European Heart Failure Self-Care Behavior Scale-Caregivers Version

Heart Failure Clinical Trial

Official title:

The Turkish Validity-Reliability Study of the European Heart Failure Self-Care Behavior Scale-Caregivers Version (AKYÖDÖ-BV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420688
• Other study ID #: 268347889
• Status: Completed
• Start date: June 12, 2022
• Est. completion date: September 10, 2023

Study information

• Verified date: January 2024
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the European Heart Failure Self-Care Behavior Questionnaire for Caregivers.

Description:

This research will be of descriptive type. The population of the study will be heart failure patients who applied to the University Hospital Cardiology clinic and polyclinic. The sample of the study will consist of patients who meet the research criteria and agree to participate in the study. The data collection tools of the study are the patient questionnaire (17 questions), the European Heart Failure Self-Care Behavior Scale for Caregivers (9 questions) and the Caregiver Contribution Scale in Heart Failure Self-Care, which was conducted by the researchers by scanning the literature. English Turkish translations will be made before starting the research. Afterwards, expert opinion will be taken for the suitability of the scale items. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language and content validity will be done for the scale form. The scale items will be translated into Turkish and expert opinions will be taken. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language validity and content validity will be done in the study. Explanatory Factor Analysis will be applied for the validity of the questionnaire. Kaiser Meyer Olkin(KMO) Test, which measures the adequacy of sample size as antecedent tests, and Bartlett's Test For Sphericity will be used to test sphericity. Factor Analysis Principal Component Analysis Method will be applied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 10, 2023
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be over 18
• To be a caregiver for patients with heart failure for at least 1 year.
• Volunteer to participate in the research.

Exclusion Criteria:

• Having communication problems and mental problems.
• be under the age of 18.
• Receiving hemodialysis treatment for less than 6 months.

Related Conditions & MeSH terms

• Heart Failure
• Self Care

Intervention

Other:
• Heart Failure Group
This is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.

Locations

Country	Name	City	State
Turkey	Harran University	Sanliurfa	Türki?ye

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Heart Failure Self-Care Behavior Scale for Caregivers	Using a five-point Likert scale, patients report the extent to which they agree with the statements corresponding to the 9-item self-care behavior (for example, weighing oneself every day), with responses ranging from "totally agree" to "disagree".	Baseline
Primary	Scale of Caregiver Contribution in Heart Failure Self-Care	"Caregiver contribution scale in heart failure self-care", which consists of 22 items, consists of 3 separate scales.	Baseline