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

January 19, 2024 updated by: İbrahim Caner Di̇ki̇ci̇, Harran University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Türki̇ye
      • Şanlıurfa, Türki̇ye, Turkey, 63000
        • Harran University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with Type 2 Diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harran University

Investigators

  • Study Director: İbrahim C Di̇ki̇ci̇, MSc, Harran University
  • Study Chair: Zeynal Yasacı, MSc, Harran University
  • Study Chair: Derya Tülüce, PhD, Osmaniye Korkut Ata University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Actual)

December 10, 2022

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25746723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot

Clinical Trials on Type 2 diabetes group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe