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

Primary Purpose

Diabetes Foot Care

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Diabetes Foot Care Education (DFCE)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Foot Care focused on measuring Diabetes, Feasibility, Acceptability, Practicability, Foot-Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Gondar Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Simulation-Based Arm

Standard Care Arm

Arm Description

Access virtual simulation-based diabetes foot care education once for 30 minutes plus the standard care.

Participants will continue utilizing the usual follow-up diabetes care which occurs every month.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 3, 2021
Last Updated
April 19, 2023
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT04841291
Brief Title
Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia
Official Title
Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Foot Care
Keywords
Diabetes, Feasibility, Acceptability, Practicability, Foot-Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Access to virtual simulation-based diabetes foot care education for once for 30 minutes.
Masking
Outcomes Assessor
Masking Description
Data collectors will not be informed about participants' group allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Simulation-Based Arm
Arm Type
Experimental
Arm Description
Access virtual simulation-based diabetes foot care education once for 30 minutes plus the standard care.
Arm Title
Standard Care Arm
Arm Type
No Intervention
Arm Description
Participants will continue utilizing the usual follow-up diabetes care which occurs every month.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Foot Care Education (DFCE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of participants who accepted the virtual simulation-based foot care education.
Description
Number of participants who scored 70 and above for the virtual simulation-based foot care education acceptance questionnaire.
Time Frame
One week after the commencement of intervention.
Title
The number of participants who believed in the practicality of the virtual simulation-based foot care education.
Description
Number of participants who scored 70 and above for the virtual simulation-based foot care education practicality questionnaire.
Time Frame
One week after the commencement of intervention.
Secondary Outcome Measure Information:
Title
The participants' level of foot self-care knowledge.
Description
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.
Time Frame
Baseline and week one.
Title
The participants' level of foot self-care behavior.
Description
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.
Time Frame
Baseline and week one.
Title
The participants' level of foot self-care efficacy to perform recommended diabetic foot self-care activities.
Description
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.
Time Frame
Baseline and week one.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fisseha Zewdu Amdie, Msc.
Phone
251-918-046567
Email
18fza@queensu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Woo, Ph.D.
Phone
1 613-533-6000
Ext
74747
Email
kevin.woo@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fisseha Zewdu Amdie, Msc.
Organizational Affiliation
School of Nursing, Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Woo, Ph.D.
Organizational Affiliation
School of Nursing, Queen's University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marian Luctkar-Flude, Ph.D.
Organizational Affiliation
School of Nursing, Queen's University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erna Snelgrove-Clarke, Ph.D.
Organizational Affiliation
School of Nursing, Queen's University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mona Sawhney, Ph.D.
Organizational Affiliation
School of Nursing, Queen's University
Official's Role
Study Director
Facility Information:
Facility Name
University of Gondar Referral Hospital
City
Gondar
State/Province
Amhara
ZIP/Postal Code
196
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fisseha Zewdu Amdie, Msc.
Phone
251-918046567
Email
18fza@queensu.ca
First Name & Middle Initial & Last Name & Degree
Fisseha Zewdu Amdie, Msc.
First Name & Middle Initial & Last Name & Degree
Kevin Woo, Ph.D.
First Name & Middle Initial & Last Name & Degree
Marian Luctkar-Flude, Ph.D.
First Name & Middle Initial & Last Name & Degree
Erna Snelgrove-Clarke, Ph.D.
First Name & Middle Initial & Last Name & Degree
Mona Sawhney, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
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Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia

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