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Recruiting NCT07462741

The Effectiveness of Education in Diabetic Hemodialysis Patients

No phase Interventional Hemodialysis Patient Diabetes Foot Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diabetic Foot Care Training.
Who it may be relevant to
Registry conditions: Hemodialysis Patient, Diabetes Foot Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Health Belief Model Approach in Diabetic Foot Management: The Effectiveness of Education for Diabetic Hemodialysis Patients

Overview

Diabetes is a significant health problem affecting approximately half a billion people worldwide, reaching alarming levels. Diabetic foot ulcers are among the most common and serious complications of diabetes. Diabetes is the most common cause of end-stage renal failure, and diabetic nephropathy is identified as a major risk factor for foot ulcers and amputation. The health belief model is a model that explains behavior. Focusing on the necessary motivational resources for the development of positive health behaviors in individuals is crucial for positive patient outcomes in the education of diabetic hemodialysis patients. It is necessary for hemodialysis nurses to educate diabetic patients on foot care knowledge, improve foot care behaviors, and prevent the development of foot ulcers and lower extremity amputations. However, the lack of studies in the literature on nurse-led foot care education interventions based on the health belief model for diabetic patients undergoing hemodialysis constitutes the strength and unique aspect of this study. The research will be conducted using a randomized controlled pretest-posttest design.

Detailed description

Diabetes is a significant health problem affecting approximately half a billion people worldwide, reaching alarming levels. Diabetic foot ulcers are among the most common and serious complications of diabetes. Diabetes is the most common cause of end-stage renal failure, and diabetic nephropathy is identified as a major risk factor for foot ulcers and amputation. The health belief model is a model that explains behavior. Focusing on the necessary motivational resources for the development of positive health behaviors in individuals is crucial for positive patient outcomes in the education of diabetic hemodialysis patients. It is necessary for hemodialysis nurses to educate diabetic patients on foot care knowledge, improve foot care behaviors, and prevent the development of foot ulcers and lower extremity amputations. However, the lack of studies in the literature on nurse-led foot care education interventions based on the health belief model for diabetic patients undergoing hemodialysis constitutes the strength and unique aspect of this study. The research will be conducted using a randomized controlled pretest-posttest design. The study population will consist of diabetic hemodialysis patients in the hemodialysis units of Firat University Hospital and Fethi Sekin City Hospital, and in the Private Elazığ Dialysis Center. The sample will consist of 50 individuals in total, 25 for each group (experimental and control) determined by power analysis. Individuals will be randomly assigned to the experimental and control groups. Research data will be collected using a Personal Information Form, the Diabetic Foot Knowledge Scale, the Foot Care Behavior Scale, and the Diabetic Foot Care Self-Efficacy Scale. The research will determine how diabetic foot care training, prepared according to the Health Belief Model, affects the foot care knowledge levels, foot care behaviors, and self-efficacy of diabetic hemodialysis patients. Based on the results obtained, the aim is to increase the importance of foot care in the treatment protocol of diabetic patients in hemodialysis units.

Interventions

  • Other Diabetic Foot Care Training
    The training will be conducted using an educational booklet prepared in accordance with the Health Belief Model. After collecting pre-test data, the training will be given to the experimental group for 2 weeks, and in order to ensure behavioral change in 4 weeks, reminders about foot care will be given to patients in dialysis centers or by phone, and then the final test data will be applied to both the experimental and control groups. During this process, the control group will continue to recei

Primary outcome measures

  • Evaluation of the effect of diabetic foot care training, prepared according to the Health Belief Model, on the foot care knowledge levels of diabetic hemodialysis patients. [Time frame: 6 weeks]
  • Evaluation of the effect of diabetic foot care training, prepared according to the Health Belief Model, on foot care behaviors. [Time frame: 6 weeks]
  • Evaluation of the effect of diabetic foot care training, prepared according to the Health Belief Model, on self-efficacy. [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • Voluntary participation in the study
  • Literacy
  • Absence of psychiatric distress
  • Being over 18 years of age
  • Open to communication and cooperation, no speech problems
  • Receiving continuous hemodialysis treatment
  • Having been diagnosed with diabetes for at least 6 months

Exclusion criteria

  • Unwillingness to participate in the study or desire to withdraw from the study
  • Receiving acute hemodialysis treatment
  • Being under 18 years of age
  • Open to communication and cooperation, no speech problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 3 centers
  • Fethi Sekin Şehir Hastanesi — Elâzığ
  • Fırat Üniversitesi Hastanesi — Elâzığ
  • Özel Elazığ Diyaliz Merkezi — Elâzığ

Identifiers

NCT: NCT07462741 · INONU-SBF-ÖCS-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗