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

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.

Completed

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Key information

Conditions

Diabete Type 2 Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Harran University

Sanliurfa, Türki̇ye, 63000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type 2 diabetes group

Other

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.

Other names: Assesment

Primary outcomes

Diabetic Foot Self-Care Questionnaire

Time frame: Baseline

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.

Secondary outcomes

Foot Care Behavior Scale

Time frame: Baseline

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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jun 3, 2022
Registry last updated: Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed