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

NCT04841291 | Unknown DMC

• 1 other identifier: 6032644
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Diabetes Foot Care

Keywords

Diabetes; Feasibility; Acceptability; Practicability; Foot-Care

Outcome Measures

Primary Outcomes (2)

• 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.

  One week after the commencement of intervention.

• 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.

  One week after the commencement of intervention.

Secondary Outcomes (3)

• 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.

Study Arms (2)

Virtual Simulation-Based Arm

EXPERIMENTAL

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

Behavioral: Diabetes Foot Care Education (DFCE)

Standard Care Arm

NO INTERVENTION

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

Interventions

Diabetes Foot Care Education (DFCE) BEHAVIORAL

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.

Virtual Simulation-Based Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisseha Z Amdie: lead

Study Sites (1)

University of Gondar Referral Hospital

Gonder, Amhara, 196, Ethiopia

RECRUITING

Related Publications (31)

• Abate TW, Enyew A, Gebrie F, Bayuh H. Nurses' knowledge and attitude towards diabetes foot care in Bahir Dar, North West Ethiopia. Heliyon. 2020 Nov 23;6(11):e05552. doi: 10.1016/j.heliyon.2020.e05552. eCollection 2020 Nov.

  PMID: 33294694 BACKGROUND

• Aklilu T, Hiko D, Mohammed MA, Dekema NH. Diabetic Patients' Knowledge of Their Disease, Therapeutic Goals, and Self-management: Association With Goal Attainment at Dessie Referral Hospital, Ethiopia. Ther Innov Regul Sci. 2014 Sep;48(5):583-591. doi: 10.1177/2168479014524960.

  PMID: 30231456 BACKGROUND

• Worku D, Hamza L, Woldemichael K. Patterns of diabetic complications at jimma university specialized hospital, southwest ethiopia. Ethiop J Health Sci. 2010 Mar;20(1):33-9. doi: 10.4314/ejhs.v20i1.69424.

  PMID: 22434958 BACKGROUND

• Angamo MT, Melese BH, Ayen WY. Determinants of glycemic control among insulin treated diabetic patients in Southwest Ethiopia: hospital based cross sectional study. PLoS One. 2013 Apr 19;8(4):e61759. doi: 10.1371/journal.pone.0061759. Print 2013.

  PMID: 23620789 BACKGROUND

• Aschalew AY, Yitayal M, Minyihun A, Bisetegn TA. Self-care practice and associated factors among patients with diabetes mellitus on follow up at University of Gondar Referral Hospital, Gondar, Northwest Ethiopia. BMC Res Notes. 2019 Sep 18;12(1):591. doi: 10.1186/s13104-019-4630-4.

  PMID: 31533833 BACKGROUND

• Beran D, Yudkin JS. Diabetes care in sub-Saharan Africa. Lancet. 2006 Nov 11;368(9548):1689-95. doi: 10.1016/S0140-6736(06)69704-3.

  PMID: 17098088 BACKGROUND

• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Boren SA, Gunlock TL, Peeples MM, Krishna S. Computerized learning technologies for diabetes: a systematic review. J Diabetes Sci Technol. 2008 Jan;2(1):139-46. doi: 10.1177/193229680800200121.

  PMID: 19885190 BACKGROUND

• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

  PMID: 19362699 BACKGROUND

• Chali SW, Salih MH, Abate AT. Self-care practice and associated factors among Diabetes Mellitus patients on follow up in Benishangul Gumuz Regional State Public Hospitals, Western Ethiopia: a cross-sectional study. BMC Res Notes. 2018 Nov 26;11(1):833. doi: 10.1186/s13104-018-3939-8.

  PMID: 30477553 BACKGROUND

• Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.

  PMID: 29496507 BACKGROUND

• Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J. 2010 Dec;1(3):7-9. doi: 10.1055/s-0030-1267062. No abstract available.

  PMID: 22956922 BACKGROUND

• Dube L, Van den Broucke S, Dhoore W, Kalweit K, Housiaux M. An Audit of Diabetes Self-Management Education Programs in South Africa. J Public Health Res. 2015 Nov 17;4(3):581. doi: 10.4081/jphr.2015.581. eCollection 2015 Nov 17.

  PMID: 26753160 BACKGROUND

• Edelman SV. Taking Control Of Your Diabetes: An Innovative Approach to Improving Diabetes Care Through Educating, Motivating, and Making the Connection Between Patients and Health Care Providers. Clin Diabetes. 2017 Dec;35(5):333-339. doi: 10.2337/cd17-0090. No abstract available.

  PMID: 29263578 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.

  PMID: 18352969 BACKGROUND

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Embil JM, Albalawi Z, Bowering K, Trepman E. Foot Care. Can J Diabetes. 2018 Apr;42 Suppl 1:S222-S227. doi: 10.1016/j.jcjd.2017.10.020. No abstract available.

  PMID: 29650101 BACKGROUND

• Foronda CL, Fernandez-Burgos M, Nadeau C, Kelley CN, Henry MN. Virtual Simulation in Nursing Education: A Systematic Review Spanning 1996 to 2018. Simul Healthc. 2020 Feb;15(1):46-54. doi: 10.1097/SIH.0000000000000411.

  PMID: 32028447 BACKGROUND

• Gudina EK, Amade ST, Tesfamichael FA, Ram R. Assessment of quality of care given to diabetic patients at Jimma University Specialized Hospital diabetes follow-up clinic, Jimma, Ethiopia. BMC Endocr Disord. 2011 Dec 20;11:19. doi: 10.1186/1472-6823-11-19.

  PMID: 22185229 BACKGROUND

• Indrayana S, Guo SE, Lin CL, Fang SY. Illness Perception as a Predictor of Foot Care Behavior Among People With Type 2 Diabetes Mellitus in Indonesia. J Transcult Nurs. 2019 Jan;30(1):17-25. doi: 10.1177/1043659618772347. Epub 2018 Apr 26.

  PMID: 29699462 BACKGROUND

• Johnson C, Feenan K, Setliff G, Pereira K, Hassell N, Beresford HF, Epps S, Nicollerat J, Tatum W, Feinglos M, Vorderstrasse A. Building a Virtual Environment for Diabetes Self-Management Education and Support. Int J Virtual Communities Soc Netw. 2013;5(3):111359. doi: 10.4018/ijvcsn.2013070105.

  PMID: 25699133 BACKGROUND

• Kasiya MM, Mang'anda GD, Heyes S, Kachapila R, Kaduya L, Chilamba J, Goodson P, Chalulu K, Allain TJ. The challenge of diabetic foot care: Review of the literature and experience at Queen Elizabeth Central Hospital in Blantyre, Malawi. Malawi Med J. 2017 Jun;29(2):218-223. doi: 10.4314/mmj.v29i2.26. No abstract available.

  PMID: 28955436 BACKGROUND

• Lateef F. Simulation-based learning: Just like the real thing. J Emerg Trauma Shock. 2010 Oct;3(4):348-52. doi: 10.4103/0974-2700.70743.

  PMID: 21063557 BACKGROUND

• Luctkar-Flude M, Tyerman J, Ziegler E, Carroll B, Shortall C, Chumbley L, Tregunno D. Developing a Sexual Orientation and Gender Identity Nursing Education Toolkit. J Contin Educ Nurs. 2020 Sep 1;51(9):412-419. doi: 10.3928/00220124-20200812-06.

  PMID: 32833031 BACKGROUND

• McInnes A, Jeffcoate W, Vileikyte L, Game F, Lucas K, Higson N, Stuart L, Church A, Scanlan J, Anders J. Foot care education in patients with diabetes at low risk of complications: a consensus statement. Diabet Med. 2011 Feb;28(2):162-7. doi: 10.1111/j.1464-5491.2010.03206.x.

  PMID: 21219423 BACKGROUND

• Petit dit Dariel OJ, Raby T, Ravaut F, Rothan-Tondeur M. Developing the Serious Games potential in nursing education. Nurse Educ Today. 2013 Dec;33(12):1569-75. doi: 10.1016/j.nedt.2012.12.014. Epub 2013 Jan 16.

  PMID: 23332500 BACKGROUND

• Sari Y, Upoyo AS, Isworo A, Taufik A, Sumeru A, Anandari D, Sutrisna E. Foot self-care behavior and its predictors in diabetic patients in Indonesia. BMC Res Notes. 2020 Feb 1;13(1):38. doi: 10.1186/s13104-020-4903-y.

  PMID: 32005281 BACKGROUND

• Torgerson DJ, Roberts C. Understanding controlled trials. Randomisation methods: concealment. BMJ. 1999 Aug 7;319(7206):375-6. doi: 10.1136/bmj.319.7206.375. No abstract available.

  PMID: 10435967 BACKGROUND

• Verkuyl M, Hughes M, Tsui J, Betts L, St-Amant O, Lapum JL. Virtual Gaming Simulation in Nursing Education: A Focus Group Study. J Nurs Educ. 2017 May 1;56(5):274-280. doi: 10.3928/01484834-20170421-04.

  PMID: 28467555 BACKGROUND

• Zhang Y, Liu C, Luo S, Xie Y, Liu F, Li X, Zhou Z. Factors Influencing Patients' Intentions to Use Diabetes Management Apps Based on an Extended Unified Theory of Acceptance and Use of Technology Model: Web-Based Survey. J Med Internet Res. 2019 Aug 13;21(8):e15023. doi: 10.2196/15023.

  PMID: 31411146 BACKGROUND

• Amdie FZ, Luctkar-Flude M, Snelgrove-Clarke E, Sawhney M, Alemu S, Woo K. Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients with Diabetes in Ethiopia: Protocol for a Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2022 Mar 31;15:995-1009. doi: 10.2147/DMSO.S345722. eCollection 2022.

  PMID: 35386589 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Fisseha Zewdu Amdie, Msc.

  School of Nursing, Queen's University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Fisseha Zewdu Amdie, Msc.

CONTACT

251-918-046567; 18fza@queensu.ca

Kevin Woo, Ph.D.

CONTACT

1 613-533-6000; kevin.woo@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors will not be informed about participants' group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 12, 2021
• Study Start: January 25, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)