Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia

Study Overview
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Brief Summary
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The primary aim of this study is to evaluate the feasibility of virtual simulation-based diabetes foot care education on foot care knowledge and practice/behaviour. Research Questions The primary question for this study is: • Is virtual simulation-based diabetes foot care education a practical and acceptable intervention among patients with diabetes in Ethiopia? The secondary questions are: What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care knowledge among patients with diabetes mellitus? What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care behaviour among patients with diabetes mellitus? What is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care efficacy among patients with diabetes mellitus? What is the impact of virtual simulation-based diabetes foot care education on diabetes foot health-belief among patients with diabetes mellitus?

Official Title
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Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia

Conditions
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Diabetes Foot Care

Intervention / Treatment
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* Behavioral: Diabetes Foot Care Education (DFCE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years of age or older). Type II diabetes mellitus patients who are on diabetes follow-up at University of Gondar tertiary referral hospital Exclusion Criteria: Patients with type 1 diabetes or gestational diabetes Patients who previously attended any form of formal Diabetes Self Management Education (DSME) program /documented/ in the past three months. Individuals with documented severe cognitive impairment Individuals with documented visual impairment that diminished their ability to navigate the game Terminally ill individuals Individuals without the ability to read or understand the Amharic consent documentation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Access to virtual simulation-based diabetes foot care education for once for 30 minutes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Simulation-Based Arm<br>Access virtual simulation-based diabetes foot care education once for 30 minutes plus the standard care. | Behavioral: Diabetes Foot Care Education (DFCE)<br>* Virtual simulation-based DFCE sessions on seven topics (the reasons for inspecting one's feet, risk factors and prevention strategies of diabetic foot ulcer, how to wash and moisturize feet, comfortable sock and shoe choices, what to look for, and what to do during feet inspection, how to trim fingernails, and how to maintain foot health) at University of Gondar computer lab for 30 minutes.<br>|
| No Intervention: Standard Care Arm<br>Participants will continue utilizing the usual follow-up diabetes care which occurs every month. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who accepted the virtual simulation-based foot care education. | Number of participants who scored 70 and above for the virtual simulation-based foot care education acceptance questionnaire. | One week after the commencement of intervention. | 
| The number of participants who believed in the practicality of the virtual simulation-based foot care education. | Number of participants who scored 70 and above for the virtual simulation-based foot care education practicality questionnaire. | One week after the commencement of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The participants' level of foot self-care knowledge. | Mean change from the baseline in foot self-care knowledge of participants one week after the commencement of the intervention. Diabetes foot self-care knowledge will be assessed with the Foot Care Knowledge (FCK) questionnaire. The Foot Care Knowledge questions evaluate the respondent's foot care knowledge. The maximum possible knowledge score will be 11 and can range from 1 to 11. A higher score means a better foot self-care knowledge. | Baseline and week one. | 
| The participants' level of foot self-care behavior. | Mean change from the baseline in foot self-care behavior of participants one week after the commencement of the intervention. Diabetes Foot Care Behavior will be assessed with the 15-item Foot Self-Care Behavior Scale (FSCBS). The Foot Self-Care Behavior Scale is a brief self-report questionnaire that measures foot care behavior. Patients will be asked to choose the most suitable response; never (1), rarely (2), sometimes (3), often (4), and always (5) to each question. The score ranged from 15-75 and a higher score indicates a better foot self-care behavior. | Baseline and week one. | 
| The participants' level of foot self-care efficacy to perform recommended diabetic foot self-care activities. | Mean change from the baseline in foot self-care efficacy of participants one week after the commencement of the intervention. This will be measured with Foot Care Confidence Scale (FCCS). The tool consists of 12 items on a 5-point Likert scale strongly not confident (1), not confident (2), moderately confident (3), confident (4), and strongly confident (5). The score ranged from 12 - 60; a higher score indicates a higher level of diabetes foot self-care efficacy. | Baseline and week one. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Feasibility, Acceptability, Practicability, Foot-Care