NCT05395442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 24, 2022

Last Update Submit

May 29, 2023

Conditions

Keywords

Diabetic Foot, HBM, Web Based, Self Effectiveness, Self Care

Outcome Measures

Primary Outcomes (2)

  • 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.

    a month or two

  • 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.

    a month or two

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No action will be taken.

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl Universty

Van, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Yakup SARPDAĞI, Ph.D

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, İnvestigator,Outcomes Assessor)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A total of 142 people, 71 people in the experimental group and 71 people in the control group, were included in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

June 3, 2022

Primary Completion

December 14, 2022

Study Completion

May 15, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations