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

NCT ID: NCT06780631

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-17

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Foot Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a prospective intervention type three-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as web-based diabetic foot training, Group-2 (Experiment) was designed s face-to-face diabetic foot training, and Group-3 (Control) was designed as clinical routine training.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Due to diabetic foot training was applied as an intervention, patients and the researcher will not be considered blind. The evaluator will be considered blind in the analysis of the study.

Study Groups

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Group-1 (Web-based diabetic foot education applied group)

1. In the first interview, individuals in the web training group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital.
2. After the pre-test, a username and password will be defined for individuals in the web training group so that they can log in to the diabetic foot web training page.
3. Patients will be trained on how to access the diabetic foot web training page, how to access information, and how to use videos.
4. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews.

Group Type EXPERIMENTAL

Web-based diabetic foot education based on health promotion model

Intervention Type OTHER

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

Group-2 (Face to face diabetic foot education applied group)

1. In the first meeting for individuals in the face-to-face education group; Within the scope of the pre-test, the Patient Information Form, Diabetic Foot Information Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital.
2. After the pre-test, face-to-face diabetic foot training will be given in accordance with the training booklet for approximately 45 minutes.
3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews.

Group Type EXPERIMENTAL

Face to face diabetic foot education based on health promotion model

Intervention Type 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.

Group-3 Clinical routine education applied group (control)

1\. In the first interview, individuals in the control group who met the inclusion criteria and agreed to participate in the research; Within the scope of the pre-test, the Patient Information Form, Foot Care Behavior Checklist, Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be administered by the researcher in the diabetes education unit of the hospital. 2. After the pre-test, individuals in the control group will receive routine training given by the training nurse on duty in the diabetes education unit. Education based on the health promotion model will not be implemented. 3. After the first application, in the first and third months, patients will be invited to the diabetes education unit and the Diabetic Foot Knowledge Scale, Foot Care Behavior Scale and Diabetic Foot Care Self-Efficacy Scale will be re-administered by the researcher through face-to-face interviews.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-based diabetic foot education based on health promotion model

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

Intervention Type OTHER

Face to face diabetic foot education based on health promotion model

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Aysun Kürkçü

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysun Kürkçü

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr.Lütfi Kırdar City Hospital İstanbul, Turkey

Locations

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Kartal Dr.Lütfi Kırdar City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Sahin S, Cingil D. Evaluation of the relationship among foot wound risk, foot self-care behaviors, and illness acceptance in patients with type 2 diabetes mellitus. Prim Care Diabetes. 2020 Oct;14(5):469-475. doi: 10.1016/j.pcd.2020.02.005. Epub 2020 Feb 27.

Reference Type RESULT
PMID: 32115378 (View on PubMed)

Pourkazemi A, Ghanbari A, Khojamli M, Balo H, Hemmati H, Jafaryparvar Z, Motamed B. Diabetic foot care: knowledge and practice. BMC Endocr Disord. 2020 Mar 20;20(1):40. doi: 10.1186/s12902-020-0512-y.

Reference Type RESULT
PMID: 32192488 (View on PubMed)

Kilic M, Karadag A. Developing and Evaluating a Mobile Foot Care Application for Persons With Diabetes Mellitus: A Randomized Pilot Study. Wound Manag Prev. 2020 Oct;66(10):29-40.

Reference Type RESULT
PMID: 33048829 (View on PubMed)

Chau JP, Chung LC, Wong RY, Loo KM, Lo SH, So TT, Lau MS, Yeung TH, Leung BS, Tong ML, Li CY, Kwok WW, Thompson DR, Lee DT. An evaluation of a web-based diabetes education program designed to enhance self-management among patients living with diabetes. Comput Inform Nurs. 2012 Dec;30(12):672-9. doi: 10.1097/NXN.0b013e318261f1d2.

Reference Type RESULT
PMID: 22872044 (View on PubMed)

Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.

Reference Type RESULT
PMID: 31311727 (View on PubMed)

Other Identifiers

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09.2023.240

Identifier Type: -

Identifier Source: org_study_id

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