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

Sponsor
Queen's University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04841291
Collaborator
(none)
40
1
2
7.7
5.2

Study Details

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diabetes Foot Care Education (DFCE)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Access to virtual simulation-based diabetes foot care education for once for 30 minutes.Access to virtual simulation-based diabetes foot care education for once for 30 minutes.
Masking:
Single (Outcomes Assessor)
Masking Description:
Data collectors will not be informed about participants' group allocation.
Primary Purpose:
Supportive Care
Official Title:
Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients With Diabetes in Ethiopia
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Gondar Referral Hospital Gondar Amhara Ethiopia 196

Sponsors and Collaborators

  • Queen's University

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fisseha Z Amdie, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier:
NCT04841291
Other Study ID Numbers:
  • 6032644
First Posted:
Apr 12, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fisseha Z Amdie, Assistant Professor, Queen's University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022