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

Not Applicable

Active, not recruiting

• Conditions: Diabetic Foot; Diabetes Mellitus Type 2

• Registration Number: NCT06780631
• Lead Sponsor: Marmara University

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.

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 Timeline

• Study Start: 2024-05-17
• Primary Completion: 2024-10-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetes Foot Knowledge Level	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.
Foot Care Behavior	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.
Foot Care Self-Efficacy	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.

Trial Locations

Locations (1)

Kartal Dr.Lütfi Kırdar City Hospital; 🇹🇷 Istanbul, Turkey