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

December 19, 2023 updated by: Fisseha Z Amdie

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fisseha Zewdu Amdie, Msc.
  • Phone Number: 251-918-046567
  • Email: 18fza@queensu.ca

Study Contact Backup

Study Locations

  • Ethiopia
    • Amhara
      • Gondar, Amhara, Ethiopia, 196
        • Recruiting
        • University of Gondar Referral Hospital
        • Contact:
        • Principal Investigator:
          • Fisseha Zewdu Amdie, Msc.
        • Sub-Investigator:
          • Kevin Woo, Ph.D.
        • Sub-Investigator:
          • Marian Luctkar-Flude, Ph.D.
        • Sub-Investigator:
          • Erna Snelgrove-Clarke, Ph.D.
        • Sub-Investigator:
          • Mona Sawhney, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Simulation-Based Arm
Access virtual simulation-based diabetes foot care education once for 30 minutes plus the standard care.
Behavioral: Diabetes 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.
No Intervention: Standard Care Arm
Participants will continue utilizing the usual follow-up diabetes care which occurs every month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants who accepted the virtual simulation-based foot care education.
Time Frame: 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.
One week after the commencement of intervention.
The number of participants who believed in the practicality of the virtual simulation-based foot care education.
Time Frame: 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.
One week after the commencement of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The participants' level of foot self-care knowledge.
Time Frame: 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.
Baseline and week one.
The participants' level of foot self-care behavior.
Time Frame: 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.
Baseline and week one.
The participants' level of foot self-care efficacy to perform recommended diabetic foot self-care activities.
Time Frame: 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.
Baseline and week one.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisseha Z Amdie

Investigators

  • Principal Investigator: Fisseha Zewdu Amdie, Msc., School of Nursing, Queen's University
  • Study Director: Kevin Woo, Ph.D., School of Nursing, Queen's University
  • Study Director: Marian Luctkar-Flude, Ph.D., School of Nursing, Queen's University
  • Study Director: Erna Snelgrove-Clarke, Ph.D., School of Nursing, Queen's University
  • Study Director: Mona Sawhney, Ph.D., School of Nursing, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

April 3, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6032644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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