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RecruitingNCT07462741Updated Mar 10, 2026

The Effectiveness of Education in Diabetic Hemodialysis Patients

An interventional study of Diabetic Foot Care Training in Hemodialysis Patient and Diabetes Foot Care, sponsored by Inonu University. Recruiting at 3 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Inonu University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hemodialysis Patient
  • Diabetes Foot Care

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Keywords

  • Diabetic foot
  • patient education
  • hemodialysis
  • self-efficacy
  • health belief model
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    group that will receive diabetic foot education

    Group that will receive diabetic foot education

    Other: Diabetic Foot Care Training

  • No intervention
    group that will not receive diabetic foot education

    no intervention will be made on the group

Interventions

  • OtherDiabetic 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 receive standard treatment and no intervention will be performed.

06

What researchers measure

Primary outcomes

  1. 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.

    The Diabetic Foot Knowledge Scale will be used to measure the foot care knowledge levels of the patients.

    Time frame: 6 weeks

  2. Evaluation of the effect of diabetic foot care training, prepared according to the Health Belief Model, on foot care behaviors.

    The Foot Care Behavior Scale will be used to measure foot care behaviors.

    Time frame: 6 weeks

  3. Evaluation of the effect of diabetic foot care training, prepared according to the Health Belief Model, on self-efficacy.

    The Diabetic Foot Care Self-Efficacy Scale will be used to evaluate self-efficacy.

    Time frame: 6 weeks

07

Study locations

3 of 3 sites recruiting
  • Fethi Sekin Şehir Hastanesi
    Elâzığ, Merkez 23000, Turkey (Türkiye)
    Recruiting
  • Fırat Üniversitesi Hastanesi
    Elâzığ, Merkez 23000, Turkey (Türkiye)
    • fırat üniversitesi hastanesi fırat üniversitesi hastanesi · Contact · hastane@firat.edu.tr · 04242333555
    Recruiting
  • Özel Elazığ Diyaliz Merkezi
    Elâzığ, Merkez 23000, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07462741
Lead sponsor
Inonu University
Responsible party
Özlem Coşkun Susem (PhD Student, Inonu University) — Principal investigator
First posted
Mar 10, 2026
Start date
Jan 26, 2026
Primary completion
Mar 9, 2026 (estimated)
Completion
Mar 9, 2026 (estimated)
Last update
Mar 10, 2026

Study contacts

özlem cs özlem coşkun susem
Contact
coskunozlm44@gmail.com
05060573533

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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