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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04841291
Enrollment
40
Registered
2021-04-12
Start date
2022-01-25
Completion date
2024-12-15
Last updated
2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Foot Care

Keywords

Diabetes, Feasibility, Acceptability, Practicability, Foot-Care

Brief summary

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?

Interventions

BEHAVIORALDiabetes Foot Care Education (DFCE)

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.

Sponsors

Fisseha Z Amdie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Data collectors will not be informed about participants' group allocation.

Intervention model description

Access to virtual simulation-based diabetes foot care education for once for 30 minutes.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of participants who accepted the virtual simulation-based foot care education.One week after the commencement of intervention.Number of participants who scored 70 and above for the virtual simulation-based foot care education acceptance questionnaire.
The number of participants who believed in the practicality of the virtual simulation-based foot care education.One week after the commencement of intervention.Number of participants who scored 70 and above for the virtual simulation-based foot care education practicality questionnaire.

Secondary

MeasureTime frameDescription
The participants' level of foot self-care knowledge.Baseline and week one.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.
The participants' level of foot self-care behavior.Baseline and week one.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.
The participants' level of foot self-care efficacy to perform recommended diabetic foot self-care activities.Baseline and week one.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.

Countries

Ethiopia

Contacts

Primary ContactFisseha Zewdu Amdie, Msc.
18fza@queensu.ca251-918-046567
Backup ContactKevin Woo, Ph.D.
kevin.woo@queensu.ca1 613-533-6000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026