Diabetic Foot Education

The Effect of Patient Education on Foot Care Behaviour and Diabetic Foot Self-Efficacy in Individuals With Type II Diabetes: A Randomised Controlled Study

To determine the effect of foot care training given according to Interpersonal Relationship Theory on foot care behaviour and diabetic foot self-efficacy.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus; Diabetic Foot Disease
• Intervention / Treatment: Behavioral: Diabetic Foot Education

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

Study Locations

• Turkey
  • Talas
    • Kayseri, Talas, Turkey, 38030
      • Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Erciyes University Health Application and Research Centre

Description

Inclusion Criteria:

• Over 18 years of age,
• Diagnosis of Type 2 DM for at least 6 months,
• Not having received planned diabetic foot training before,
• Volunteering to participate in the study,

Exclusion Criteria:

• Neuropsychiatric drug use and disease that may affect education (Dementia- Alzheimer's and Mental Retardation etc.)
• Being visually impaired,
• Hearing impairment,
• Inability to speak Turkish,
• Presence of active diabetic foot ulcer.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group
Study Grup	Behavioral: Diabetic Foot Education; Patients in the intervention group will be interviewed and their diabetic foot knowledge will be evaluated. During the interview, the individual's knowledge about the definition of diabetic foot, risk factors, symptoms, treatment, complications, care and prevention will be evaluated. In order to systematically plan, implement and evaluate the training to be used in the intervention, it is aimed to implement androgogical training based on the 'Interpersonal Relations Theory'. In this context, the stages in the theory will be followed as follows.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive Information Form:	The descriptive information form, which was created by the researchers by reviewing the literature, consists of 16 items in total, including seven questions about individual characteristics (age, gender, height, weight, education level, family structure, smoking) and nine questions about the disease and diabetic foot (HbA1c value, number of years of living with diabetes, treatment(s) received, history of diabetic foot).	2 Minutes
Diabetic Foot Self-Care Behaviour Scale	The Diabetic Outpatient Self-Care Behaviour Scale was developed by Yen-Fan Chin and Tzu-Ting Huang in 2013 (Chin & Huang, 2013). The Turkish validity and reliability study conducted by Bakır and Samancıoğlu Bağlama was published in 2021. The scale is a five-point Likert-type scale consisting of 7 items and two sections. The first part consists of four items including practices related to examining, washing and drying the soles of the feet and toes during the week. The three items in the second section are related to the use of shoes and lotion. The lowest score that can be obtained from the first section is 4 and the highest score is 20. The lowest score that can be obtained from the second section is 3 and the highest score is 15. The questionnaire is evaluated over the total score and the score that can be obtained varies between 7-35. As the score obtained from the scale increases, self-care behaviour increases.	5 minutes
Diabetic Foot Care Self-Efficacy Scale	The scale consisting of nine items is answered with an 11-digit visual scale ranging from 0-10. In the answers, the lowest value is expressed as 'I do not consider it sufficient at all' and the highest value is expressed as 'I consider it very sufficient'. The scale has no sub-dimensions and is evaluated on the total scale score. The lowest score that can be obtained from the scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.	5 minutes

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): October 26, 2024
• Primary Completion (Estimated): November 26, 2024
• Study Completion (Estimated): December 26, 2024

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Patient Education; Diabetic Foot
• Additional Relevant MeSH Terms: Endocrine System Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Diabetes Mellitus; Diabetic Foot; Foot Diseases
• Other Study ID Numbers: 16.10.2024

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