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Clinical Trials/NCT04841291
NCT04841291RecruitingNot Applicable

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

Fisseha Z Amdie2 sites in 1 country40 target enrollmentStarted: January 25, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
The number of participants who accepted the virtual simulation-based foot care education.

Study Overview

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?

Study Design

Study Type
Interventional
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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

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

Investigators

Sponsor
Fisseha Z Amdie
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Fisseha Z Amdie

Assistant Professor

Queen's University

Study Sites (2)

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