- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462741
The Effectiveness of Education in Diabetic Hemodialysis Patients
March 5, 2026 updated by: Özlem Coşkun Susem, Inonu University
The Health Belief Model Approach in Diabetic Foot Management: The Effectiveness of Education for Diabetic Hemodialysis Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: özlem cs özlem coşkun susem
- Phone Number: 05060573533
- Email: coskunozlm44@gmail.com
Study Locations
-
-
Merkez
-
Elâzığ, Merkez, Turkey (Türkiye), 23000
- Recruiting
- Fethi Sekin Şehir Hastanesi
-
Contact:
- fethi sekin şehir hastanesi fethi sekin şehir hastanesi
- Phone Number: 04246066000
- Email: elazigsehir@saglik.gov.tr
-
Elâzığ, Merkez, Turkey (Türkiye), 23000
- Recruiting
- Fırat Üniversitesi Hastanesi
-
Contact:
- fırat üniversitesi hastanesi fırat üniversitesi hastanesi
- Phone Number: 04242333555
- Email: hastane@firat.edu.tr
-
Elâzığ, Merkez, Turkey (Türkiye), 23000
- Recruiting
- Özel Elazığ Diyaliz Merkezi
-
Contact:
- özel elazığ diyaliz merkezi
- Phone Number: 04242333260
- Email: ediyaliz@hotmail.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group that will receive diabetic foot education
Group that will receive diabetic foot education
|
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.
|
|
No Intervention: group that will not receive diabetic foot education
no intervention will be made on the group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The Diabetic Foot Knowledge Scale will be used to measure the foot care knowledge levels of the patients.
|
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
|
The Foot Care Behavior Scale will be used to measure foot care behaviors.
|
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
|
The Diabetic Foot Care Self-Efficacy Scale will be used to evaluate self-efficacy.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 26, 2026
Primary Completion (Estimated)
March 9, 2026
Study Completion (Estimated)
March 9, 2026
Study Registration Dates
First Submitted
March 1, 2026
First Submitted That Met QC Criteria
March 5, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 5, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INONU-SBF-ÖCS-01
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.
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