The Effect of Web-Based and Face-to-Face Education Based on the Health Promotion Model on Foot Care Behavior in Individuals With Type 2 Diabetes
January 16, 2025 updated by: Aysun Kürkçü, Marmara University
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The research will be conducted with individuals with type 2 diabetes who volunteered to participate in the study.
As data collection tools, Patient Descriptive Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be used.
As a pre-test, data will be collected from all patients at the first interview.
Then, web-based training based on the health promotion model will be applied to the individuals in the experimental group 1 and face-to-face training will be applied to the individuals in the experimental group 2. The individuals in the control group will be given routine training applied in the hospital.
Reminder messages about foot care will be sent to the patients once a week.
After the first application, data from all individuals in experiment group 1, experiment group 2 and control group will be collected again and analyzed in the 1st and 3rd months, and the research will be completed.
Power analysis was performed using the G*Power (v3.1.9.2) program to determine the number of samples.
The power of the study is expressed as 1-β (β = probability of type II error), and in general, studies must have 80% power.
The number of samples was determined as 135 in total, 45 people in each group.
Study Type
Interventional
Enrollment (Actual)
135
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 Locations
-
-
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Istanbul, Turkey
- Kartal Dr.Lütfi Kırdar City Hospital
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-
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:
- 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
Exclusion Criteria:
- Wants to leave the study
- Foot ulcer development in a diabetic individual during work
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group-1 (Web-based diabetic foot education applied group)
|
The first group can access the training at any time and repeat the training thanks to web-based training.
|
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Experimental: Group-2 (Face to face diabetic foot education applied group)
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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.
|
|
No Intervention: Group-3 Clinical routine education applied group (control)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Foot Knowledge Level
Time Frame: 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.
|
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.
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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
Time Frame: 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.
|
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.
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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.
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Foot Care Self-Efficacy
Time Frame: 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.
|
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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aysun Kürkçü, Kartal Dr.Lütfi Kırdar City Hospital İstanbul, Turkey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
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)
May 17, 2024
Primary Completion (Actual)
October 30, 2024
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
January 13, 2025
First Submitted That Met QC Criteria
January 16, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 16, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2023.240
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
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