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Web-based Diabetic Foot Care Training Prepared With the Health Belief Model for Type 2 Diabetes Patients (dabe)

Primary Purpose

Type2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training on web-based diabetic foot care based on the Health Belief Model
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes Mellitus focused on measuring Diabetic Foot, HBM, Web Based, Self Effectiveness, Self Care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Van Yüzüncü Yıl Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

Web-supported diabetic foot care training based on health belief model

No action will be taken.

Outcomes

Primary Outcome Measures

Pre-Test Data Collection
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.
Collection of Post-Test Data
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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2022
Last Updated
May 29, 2023
Sponsor
Yuzuncu Yıl University
Collaborators
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05395442
Brief Title
Web-based Diabetic Foot Care Training Prepared With the Health Belief Model for Type 2 Diabetes Patients
Acronym
dabe
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
Collaborators
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
Diabetic Foot, HBM, Web Based, Self Effectiveness, Self Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 142 people, 71 people in the experimental group and 71 people in the control group, were included in the study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant, İnvestigator,Outcomes Assessor)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Web-supported diabetic foot care training based on health belief model
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No action will be taken.
Intervention Type
Diagnostic Test
Intervention Name(s)
Training on web-based diabetic foot care based on the Health Belief Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-Test Data Collection
Description
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.
Time Frame
a month or two
Title
Collection of Post-Test Data
Description
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.
Time Frame
a month or two

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yakup SARPDAĞI, Ph.D
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Yüzüncü Yıl Universty
City
Van
ZIP/Postal Code
65000
Country
Turkey

12. IPD Sharing Statement

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Web-based Diabetic Foot Care Training Prepared With the Health Belief Model for Type 2 Diabetes Patients

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