Turkish Validity-Reliability Study of the Diabetic Foot Self-Care Questionnaire

Diabetic Foot Clinical Trial

Official title:

Turkish Validity-Reliability Study of the Diabetic Foot Self-Care Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404178
• Other study ID #: 25746723
• Status: Completed
• Start date: June 10, 2022
• Est. completion date: December 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 is to evaluate the translation, cross-cultural adaptation and psychometric properties of the Diabetic Foot Self-Care Questionnaire in patients with primary Type 2 Diabetes.

Description:

This study will be conducted in descriptive type. The population of the research will be patients with diabetic foot in the Endocrinology clinic and polyclinic of the University Hospital. The sample of the study will consist of patients who meet the research criteria and agree to participate in the research. The data collection tools of the study are the patient questionnaire (19 questions), the Diabetic Foot Self-Care Questionnaire (16 questions) and the Foot Care Behavior Scale, by scanning the literature by the researchers.

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: 3
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be over 18 years old

• Having Type 2 Diabetes and having a diabetic foot ulcer.

• Volunteering to participate in the research.

Exclusion Criteria:

• Have a communication problem

• Presence of lower extremity amputation

• Presence of any ulcer other than diabetes

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Diabetic Foot

Intervention

Other:
• Type 2 diabetes 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	Diabetic Foot Self-Care Questionnaire	The Turkish validity and reliability of a scale consisting of 16 questions created to evaluate self-care in patients with diabetic foot has not been determined. The survey is divided into 3 areas. Areas 1 to 6 are self-care areas, Items 7 to 11 are self-management areas, and areas 12 to 16 are self-exploration areas.	Baseline
Secondary	Foot Care Behavior Scale	It was created to develop foot self-care behaviors in diabetes. The scale, which is a 5-point Likert type scale, is scored according to agree-disagreement (1= Never, 2= Sometimes, 3= Sometimes, 4= Often, and 5= Always) and consists of 15 items. The lowest score that can be obtained from the scale, which evaluates foot care behavior as a single dimension, is 15 and the highest score is 75. An increase in the scale score indicates that the individual's foot self-care behaviors are better.	Baseline