NCT07462741

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 1, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 1, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Diabetic footpatient educationhemodialysisself-efficacyhealth belief model

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 weeks

Study Arms (2)

group that will receive diabetic foot education

EXPERIMENTAL

Group that will receive diabetic foot education

Other: Diabetic Foot Care Training

group that will not receive diabetic foot education

NO INTERVENTION

no intervention will be made on the group

Interventions

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.

group that will receive diabetic foot education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fethi Sekin Şehir Hastanesi

Elâzığ, Merkez, 23000, Turkey (Türkiye)

RECRUITING

Fırat Üniversitesi Hastanesi

Elâzığ, Merkez, 23000, Turkey (Türkiye)

RECRUITING

Özel Elazığ Diyaliz Merkezi

Elâzığ, Merkez, 23000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

özlem cs özlem coşkun susem

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups, experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 10, 2026

Study Start

January 26, 2026

Primary Completion

March 9, 2026

Study Completion

March 9, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations