- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395442
Web-based Diabetic Foot Care Training Prepared With the Health Belief Model for Type 2 Diabetes Patients (dabe)
The Effect of Health Belief Model-Based Web-Based Education on Diabetic Foot Care Knowledge Levels, Behaviors and Self-Efficacy for Individuals With Type 2 Diabetes
Diabetes Mellitus (DM), insulin secretion, insulin action or this It is a chronic metabolic disease characterized by hyperglycemia caused by a defect in both of these factors.
It is an important public health problem that causes organ and function losses due to the complications it creates, negatively affects the life span and quality, and creates a social and economic burden.Diabetic foot, known as an important complication of DM, is an important problem in that it causes deterioration in the quality of life of the patient, frequent and long-term hospitalizations, serious increase in the cost of treatment, lower extremity amputations and increased mortality. As a result of the literature review, it was assumed that the level of knowledge about diabetic foot care could affect diabetic foot care behaviors, self-efficacy and possible diabetic foot complications. In addition to conventional information, a Web-based education based on a health belief model can create awareness in individuals and minimize the risk of diabetic foot ulceration or amputation. The aim of this study is to determine the effect of web-based diabetic foot care training prepared according to SIM on the knowledge levels, self-efficacy and care behaviors of individuals with diabetes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetes Mellitus (DM), insulin secretion, insulin action or this It is a chronic metabolic disease characterized by hyperglycemia caused by a defect in both of these factors.
It is an important public health problem that causes organ and function losses due to the complications it creates, negatively affects the life span and quality, and creates a social and economic burden.Diabetic foot, known as an important complication of DM, is an important problem in that it causes deterioration in the quality of life of the patient, frequent and long-term hospitalizations, serious increase in the cost of treatment, lower extremity amputations and increased mortality. As a result of the literature review, it was assumed that the level of knowledge about diabetic foot care could affect diabetic foot care behaviors, self-efficacy and possible diabetic foot complications. In addition to conventional information, a Web-based education based on a health belief model can create awareness in individuals and minimize the risk of diabetic foot ulceration or amputation. The aim of this study is to determine the effect of web-based diabetic foot care training prepared according to SIM on the knowledge levels, self-efficacy and care behaviors of individuals with diabetes.
Materials and Methods: This is a randomized controlled experimental study. The research consists of all individuals who are followed up with the diagnosis of type 2 diabetes (1008 people) registered in the Tusba Family Health Center no. Power analysis method was used to determine the sample size of the study. In the power analysis using Cohen's standard effect sizes, it was determined that 128 people, 64 in each group, should be reached in order to reach 80% power at 0.5% effect size, 0.05% margin of error level and 0.95% confidence interval. However, considering that sample loss may occur in the study, 10% more of the calculated sample will be included in the randomization process. In this case, it was determined that a total of 142 people, 71 people in each group, should be reached. In the study, Introductory Information Form, Foot Care Behavior Scale, Diabetic Foot Care Self-Efficacy Scale and Diabetic Foot Information Scale, four materials will be used.The data obtained in this study will be analyzed using the SPSS statistical program (SPSS-22).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Van, Turkey, 65000
- Van Yüzüncü Yıl Universty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with Type 2 diabetes at least 1 year ago,
- Be between the ages of 18-65,
- Ability to use computer or smartphone,
- With internet access,
- Literate,
- Not having attended training on diabetic foot care,
- Has no disability in answering questions physically, cognitively or spiritually,
- Willingness to participate in research.
Exclusion Criteria:
- Those with a diabetic foot ulcer or amputation,
- Hospitalization in inpatient treatment institutions due to DM or DM complications during the research process,
- Patients with foot deformities (such as overlapping toes),
- Moving to another city during the research process,
- The emergence of any health problem that prevents the person from continuing the research,
- Leaving the research voluntarily.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Web-supported diabetic foot care training based on health belief model
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Training on web-based diabetic foot care based on the Health Belief Model will be implemented.Four materials will be used in the research, namely the Introductory Information Form, the Foot Care Behavior Scale, the Diabetic Foot Care Self-Efficacy Scale.
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No Intervention: Control Group
No action will be taken.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-Test Data Collection
Time Frame: a month or two
|
The pre-test data of the study will be searched by the researcher between June 2022 and July 2022 by obtaining the contact information of the individuals registered in the Van Tusba Family Health Center and included in the study.
In the collection of data, the people in the experimental and control groups; Introductory Information Form, Foot Care Behavior Scale, Diabetic Foot Care Self-Efficacy Scale and Diabetic Foot Knowledge Scale" will be applied.
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a month or two
|
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Collection of Post-Test Data
Time Frame: a month or two
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Giving training to the experimental group for 6 weeks with an interval of 2 weeks.
The three-month web-based training given by the researcher to the individuals in the experimental group will be completed.
After the training is over, a three-month follow-up will be made and post-test data will be collected after 6 months in total.
It is planned to collect the final test data in Van Tusba Family Health Center No. 1 between November 2022 and December 2022.
In the collection of data, the people in the experimental and control groups; Foot Care Behavior Scale, Diabetic Foot Care Self-Efficacy Scale and Diabetic Foot Knowledge Scale will be applied.
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a month or two
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yakup SARPDAĞI, Ph.D, Yuzuncu Yıl University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yakup1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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