NCT06780631

Brief Summary

Diabetic foot is a complication that develops difficult-to-heal foot wounds, reduces the quality of life of individuals with diabetes, causes loss of productivity, and causes economic burden due to the repetition of the problem and the expenditures made for treatment. Diabetic foot is the most common complication requiring hospitalization and is the most common cause of non-traumatic amputations. However, this complication can be prevented with regular foot examinations, patient education and daily foot care. For this reason, diabetic foot education should be given to all diabetic patients and they should be encouraged to participate in their self-care. However, educating patients once does not provide enough knowledge to manage diabetes throughout life. As the rate of individuals using web-based information increases, it is possible to reach large masses. With web-based training, information obtained from current sources is presented to patients on a single web page, patients can access training regardless of place or time, and continuity in training is ensured. The aim of this randomized controlled experimental study is to determine the effect of web-based and face-to-face education based on the health promotion model on diabetic foot knowledge and foot care behavior in individuals with diabetes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 13, 2025

Last Update Submit

January 16, 2025

Conditions

Keywords

Diabetic FootSelf CareHealth Promotiom ModelWeb Based EducationFace to Face Education

Outcome Measures

Primary Outcomes (3)

  • Diabetes Foot Knowledge Level

    The scale consists of 5 items and has no subdimensions. In the evaluation of the scale, the total score of the correct questions from the answers given as 'yes' or 'no' to the knowledge question constitutes the scale score. The scoring changez as 1 or 0. An increase in the scale score indicates an increase in the level of knowledge of diabetic feet.

    The knowledge level of the patients is measured with the 5-item "Diabetes Foot Knowledge Qustionnare" ; It will be evaluated before the training, in the first month and in the third month after the training.

  • Foot Care Behavior

    The scale consists of 15 items and has no sub-dimensions. These items are evaluated as '1=Never', '2=Occasionally', '3=Sometimes', '4=Often', '5=Always'. The lowest score on the scale is 15 and the highest score is 75. An increase in the scale score indicates that the individual's self-care behaviors are better.

    Patients' foot care behaviors will be questioned with the "Foot Self Care Observation Guide" consisting of 15 items; It will be evaluated before the training, in the first month and in the third month after the training.

  • Foot Care Self-Efficacy

    The scale consists of nine items. These nine statements are evaluated on an 11-number visual scale such as 'I don't see it at all adequate = 0' and 'I consider it very adequate = 10'. The lowest score from the scale is 0 and the highest score is 90. An increase in the scale score indicates that the individual's self-efficacy is high.

    Patients' foot care self-efficacy is evaluated with the "Diabetic Foot Care Self Efficacy" consisting of 9 items; It will be evaluated before the training, in the first month and in the third month after the training.

Study Arms (3)

Group-1 (Web-based diabetic foot education applied group)

EXPERIMENTAL

1. In the first interview, individuals in the web training group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, a username and password will be defined for individuals in the web training group so that they can log in to the diabetic foot web training page. 3. Patients will be trained on how to access the diabetic foot web training page, how to access information, and how to use videos. 4. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews.

Other: Web-based diabetic foot education based on health promotion model

Group-2 (Face to face diabetic foot education applied group)

EXPERIMENTAL

1. In the first meeting for individuals in the face-to-face education group; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, face-to-face diabetic foot training will be given in accordance with the training booklet for approximately 45 minutes. 3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews.

Other: Face to face diabetic foot education based on health promotion model

Group-3 Clinical routine education applied group (control)

NO INTERVENTION

1\. In the first interview, individuals in the control group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Foot Care Behavior Checklist, Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, individuals in the control group will receive routine training given by the training nurse on duty in the diabetes education unit. Education based on the health promotion model will not be implemented. 3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews.

Interventions

The first group can access the training at any time and repeat the training thanks to web-based training.

Group-1 (Web-based diabetic foot education applied group)

Individuals with Type 2 diabetes in the face-to-face training group will receive face-to-face diabetic foot training in line with the training booklet for approximately 45 minutes, one by one.

Group-2 (Face to face diabetic foot education applied group)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with type 2 diabetes at least 6 months ago according to ADA criteria
  • Being between the ages of 18 and 80
  • Ability to read and write
  • Not having received diabetic foot training before
  • No existing foot ulcers
  • Using the Internet (from sources such as smartphone, tablet, computer)
  • Being open to communication and collaboration
  • No mental problems
  • Volunteering to participate in the study

You may not qualify if:

  • Wants to leave the study
  • Foot ulcer development in a diabetic individual during work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr.Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Sahin S, Cingil D. Evaluation of the relationship among foot wound risk, foot self-care behaviors, and illness acceptance in patients with type 2 diabetes mellitus. Prim Care Diabetes. 2020 Oct;14(5):469-475. doi: 10.1016/j.pcd.2020.02.005. Epub 2020 Feb 27.

  • Pourkazemi A, Ghanbari A, Khojamli M, Balo H, Hemmati H, Jafaryparvar Z, Motamed B. Diabetic foot care: knowledge and practice. BMC Endocr Disord. 2020 Mar 20;20(1):40. doi: 10.1186/s12902-020-0512-y.

  • Kilic M, Karadag A. Developing and Evaluating a Mobile Foot Care Application for Persons With Diabetes Mellitus: A Randomized Pilot Study. Wound Manag Prev. 2020 Oct;66(10):29-40.

  • Chau JP, Chung LC, Wong RY, Loo KM, Lo SH, So TT, Lau MS, Yeung TH, Leung BS, Tong ML, Li CY, Kwok WW, Thompson DR, Lee DT. An evaluation of a web-based diabetes education program designed to enhance self-management among patients living with diabetes. Comput Inform Nurs. 2012 Dec;30(12):672-9. doi: 10.1097/NXN.0b013e318261f1d2.

  • Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.

Related Links

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Aysun Kürkçü

    Kartal Dr.Lütfi Kırdar City Hospital İstanbul, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to diabetic foot training was applied as an intervention, patients and the researcher will not be considered blind. The evaluator will be considered blind in the analysis of the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: It is a prospective intervention type three-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as web-based diabetic foot training, Group-2 (Experiment) was designed s face-to-face diabetic foot training, and Group-3 (Control) was designed as clinical routine training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

May 17, 2024

Primary Completion

October 30, 2024

Study Completion

January 30, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations