Hemodialysis PatientNCT07462741
The Effectiveness of Education in Diabetic Hemodialysis Patients
A study testing Diabetic Foot Care Training in people with Hemodialysis Patient and Diabetes Foot Care, run by Inonu University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patient, Diabetes Foot Care
- What is being tested?
- Diabetic Foot Care Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 26 Jan 2026to 9 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Fethi Sekin Şehir Hastanesi
Elâzığ, Merkez, 23000
fethi sekin şehir hastanesi fethi sekin şehir hastanesi, 04246066000, elazigsehir@saglik.gov.tr
- Recruiting
Fırat Üniversitesi Hastanesi
Elâzığ, Merkez, 23000
fırat üniversitesi hastanesi fırat üniversitesi hastanesi, 04242333555, hastane@firat.edu.tr
- Recruiting
Özel Elazığ Diyaliz Merkezi
Elâzığ, Merkez, 23000
özel elazığ diyaliz merkezi, 04242333260, ediyaliz@hotmail.com
About this study
Official title: 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.
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.
- Conditions
- Hemodialysis Patient, Diabetes Foot Care
- Being tested
- Diabetic Foot Care Training
- Keywords
- Diabetic foot, patient education, hemodialysis, self-efficacy, health belief model
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Foot Care TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group that will receive diabetic foot education | Experimental | Group that will receive diabetic foot education Receives: Other: Diabetic Foot Care Training |
| group that will not receive diabetic foot education | No intervention | no intervention will be made on the group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start26 Jan 2026
- Primary completion9 Mar 2026 (estimated)
- Study completion9 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, experimental and control groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Coşkun Susem, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462741
- Sponsor's protocol ID
- INONU-SBF-ÖCS-01
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health Belief Model Approach in Diabetic Foot Management: The Effectiveness of Education for Diabetic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07462741
- Acronym / sponsor ID
- INONU-SBF-ÖCS-01
- Conditions
- Hemodialysis Patient, Diabetes Foot Care
- Keywords
- Diabetic foot, patient education, hemodialysis, self-efficacy, health belief model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 9 Mar 2026 (estimated)
- Study completion
- 9 Mar 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two groups, experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| group that will receive diabetic foot education | Experimental | Other: Diabetic Foot Care TrainingGroup that will receive diabetic foot education |
| group that will not receive diabetic foot education | No intervention | –no intervention will be made on the group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary participation in the study
- Literacy
- Absence of psychiatric distress
- Being over 18 years of age
- Open to communication and cooperation, no speech problems
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic Foot Care TrainingThe 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. | Other | group that will receive diabetic foot education |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic Foot Care Training in people with Hemodialysis Patient and Diabetes Foot Care, run by Inonu University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact özlem cs özlem coşkun susem (05060573533, coskunozlm44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.