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

Sponsor
Yuzuncu Yıl University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05395442
Collaborator
Ataturk University (Other)
128
1
2
6
21.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Training on web-based diabetic foot care based on the Health Belief Model
N/A

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. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A total of 128 people, 64 people in the experimental group and 64 people in the control group, will be included in the study.A total of 128 people, 64 people in the experimental group and 64 people in the control group, will be included in the study.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Triple (Participant, İnvestigator,Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jun 3, 2022
Anticipated Primary Completion Date :
Dec 3, 2022
Anticipated Study Completion Date :
Dec 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

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

Diagnostic Test: Training on web-based diabetic foot care based on the Health Belief Model
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.

No Intervention: Control Group

No action will be taken.

Outcome Measures

Primary Outcome Measures

  1. Pre-Test Data Collection [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.

  2. Collection of Post-Test Data [a month or two]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Van Yüzüncü Yıl Universty Van Turkey 65000

Sponsors and Collaborators

  • Yuzuncu Yıl University
  • Ataturk University

Investigators

  • Principal Investigator: Yakup SARPDAĞI, Ph.D, Yuzuncu Yıl University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yakup SARPDAGI, Research Assistant, Yuzuncu Yıl University
ClinicalTrials.gov Identifier:
NCT05395442
Other Study ID Numbers:
  • yakup1
First Posted:
May 27, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yakup SARPDAGI, Research Assistant, Yuzuncu Yıl University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022