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NCT Number: NCT06780631

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr.Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based diabetic foot education based on health promotion model

Other

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

Face to face diabetic foot education based on health promotion model

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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