Feasibility of Virtual Simulation-Based Diabetes Foot Care Education in Patients with Diabetes in Ethiopia: Protocol for a Randomized Controlled Trial

References

• Saeedi P, Petersohn I, Salpea P, et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019;157:107843.
   PubMed Web of Science ®Google Scholar
• Cho NH, Shaw JE, Karuranga S, et al. IDF diabetes atlas: global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018;138:271–281. doi:10.1016/j.diabres.2018.02.023
   PubMed Web of Science ®Google Scholar
• International Diabetic Federation. IDF diabetes atlas. Belgium: International Diabetic Federation; 2017.
   Google Scholar
• Nigatu T. Epidemiology, complications and management of diabetes in Ethiopia: a systematic review. J Diabetes. 2012;4(2):174–180. doi:10.1111/j.1753-0407.2011.00181.x
   PubMed Web of Science ®Google Scholar
• 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;35(5):333. doi:10.2337/cd17-0090
   Google Scholar
• Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes - A meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25(7):1159–1171. doi:10.2337/diacare.25.7.1159
   PubMed Web of Science ®Google Scholar
• Powers MA, Bardsley J, Cypress M, et al. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Diabetes Educ. 2017;43(1):40–53. doi:10.1177/0145721716689694
   PubMed Web of Science ®Google Scholar
• Funnell MM, Brown TL, Childs BP, et al. National standards for diabetes self-management education. Diabetes Care. 2012;35 Suppl 1(Supplement_1):S101–S8. doi:10.2337/dc12-s101
   Web of Science ®Google Scholar
• Fu X-L, Ding H, Miao W-W, Mao C-X, Zhan M-Q, Chen H-L. Global recurrence rates in diabetic foot ulcers: a systematic review and meta-analysis. Diabetes Metab Res Rev. 2019;35(6):e3160. doi:10.1002/dmrr.3160
   PubMed Web of Science ®Google Scholar
• Zha M-L, Cai J-Y, Chen H-L. A bibliometric analysis of global research production pertaining to diabetic foot ulcers in the past ten years. J Foot Ankle Surg. 2019;58(2):253–259. doi:10.1053/j.jfas.2018.08.052
   PubMed Web of Science ®Google Scholar
• Jiang F-H, Liu X-M, Yu H-R, Qian Y, Chen H-L. The incidence of depression in patients with diabetic foot ulcers: a systematic review and meta-analysis. Int J Low Extrem Wounds. 2020;1534734620929892. doi:10.1177/1534734620929892
   Web of Science ®Google Scholar
• Dinesh PV, Kulkarni AG, Gangadhar NK. Knowledge and self-care practices regarding diabetes among patients with Type 2 diabetes in Rural Sullia, Karnataka: a community-based, cross-sectional study. J Fam Med Prim Care. 2016;5(4):847–852. doi:10.4103/2249-4863.201176
   Google Scholar
• Hasina Akhter C, Kaniz F, Hossain S, et al. Knowledge and self-care practice regarding diabetes among type 2 diabetics: experience from a non-profit hospital chain in Bangladesh. Int J Diabetes Dev Ctries. 2017;38:1–8.
   Web of Science ®Google Scholar
• Mariye T, Tasew H, Teklay G, Gerensea H, Daba W. Magnitude of diabetes self-care practice and associated factors among type two adult diabetic patients following at public Hospitals in central zone, Tigray Region, Ethiopia, 2017. BMC Res Notes. 2018;11(1):380. doi:10.1186/s13104-018-3489-0
   Google Scholar
• 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;12(1):591. doi:10.1186/s13104-019-4630-4
   PubMed Web of Science ®Google Scholar
• Seid A, Tsige Y. Knowledge, practice, and barriers of foot care among diabetic patients attending Felege Hiwot Referral Hospital, Bahir Dar, Northwest Ethiopia. Adv Nurs. 2015;2015:934623. doi:10.1155/2015/934623
   Google Scholar
• Beran D, Yudkin JS. Diabetes care in sub-Saharan Africa. Lancet. 2006;368(9548):1689–1695. doi:10.1016/S0140-6736(06)69704-3
   PubMed Web of Science ®Google Scholar
• Feleke Y, Enquselassie F. An assessment of the health care system for diabetes in Addis Ababa, Ethiopia. Ethiop J Health Dev. 2005;19(3):203–210.
   Google Scholar
• 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;11(1):833. doi:10.1186/s13104-018-3939-8
   PubMedGoogle Scholar
• Abejew AA, Belay AZ, Kerie MW. Diabetic complications among adult diabetic patients of a tertiary hospital in Northeast Ethiopia. Adv Public Health. 2015;2015:290920. doi:10.1155/2015/290920
   Google Scholar
• Bishu KG, Jenkins C, Yebyo HG, Atsbha M, Wubayehu T, Gebregziabher M. Diabetes in Ethiopia: a systematic review of prevalence, risk factors, complications, and cost. Obesity Med. 2019;15:100132. doi:10.1016/j.obmed.2019.100132
   Google Scholar
• Wondwossen A, Reja A, Amare A. Diabetic foot disease in Ethiopian patients: a Hospital Based Study. Ethiop J Health Dev. 2011;25:17–21.
   Web of Science ®Google Scholar
• 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;11(1):19. doi:10.1186/1472-6823-11-19
   Web of Science ®Google Scholar
• Deressa W, Azazh A. Attitudes of undergraduate medical students of Addis Ababa University towards medical practice and migration, Ethiopia. BMC Med Educ. 2012;12(1):68. doi:10.1186/1472-6920-12-68
   PubMed Web of Science ®Google Scholar
• Federal Democratic Republic of Ethiopia Ministry of Health [FDRMOH]. Addressing the impact of noncommunicable diseases and injuries in Ethiopia. Ethiopia Federal Democratic Republic of Ethiopia Ministry of Health; 2018.
   Google Scholar
• Federal Democratic Republic of Ethiopia Ministry of Health. HSTP health sector transformation plan 2015/16‐2019/20 (2008‐2012 EFY). Addis Ababa: Federal Democratic Republic of Ethiopia Ministry of Health; 2015.
   Google Scholar
• Kassahun T, Eshetie T, Gesesew H. Factors associated with glycemic control among adult patients with type 2 diabetes mellitus: a cross-sectional survey in Ethiopia. BMC Res Notes. 2016;9(1):78. doi:10.1186/s13104-016-1896-7
   PubMedGoogle Scholar
• Sperl-Hillen J, O’Connor P, Ekstrom H, et al. Using simulation technology to teach diabetes care management skills to resident physicians. J Diabetes Sci Technol. 2013;7(5):1243–1254. doi:10.1177/193229681300700514
   Google Scholar
• Johnson C, Feenan K, Setliff G, et al. 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
   Google Scholar
• Schrier K. Using augmented reality games to teach 21st century skills. Boston, Massachusetts: ACM SIGGRAPH 2006 Educators program; Association for Computing Machinery; 2006: 15.
   Google Scholar
• Lateef F. Simulation-based learning: just like the real thing. J Emerg Trauma Shock. 2010;3(4):348–352. doi:10.4103/0974-2700.70743
   PubMedGoogle Scholar
• Stone RJ, Panfilov PB, Shukshunov VE. Evolution of aerospace simulation: from immersive Virtual Reality to serious games. Proceedings of 5th International Conference on Recent Advances in Space Technologies - RAST2011; 9–11 June 2011.
   Google Scholar
• Kalkman CJ. Serious play in the virtual world: can we use games to train young doctors? J Grad Med Educ. 2012;4(1):11–13. doi:10.4300/JGME-D-11-00309.1
   Google Scholar
• Downing D, Chang TP, Robertson JM, Anderson M, Diaz DA, Spain AE; Eds.; the Terminology and Concepts Working Group. Healthcare Simulation Dictionary. 2nd ed. Rockville, MD: Agency for Healthcare Research and Quality; 2020.
   Google Scholar
• Padilha JM, Machado PP, Ribeiro A, Ramos J, Costa P. Clinical virtual simulation in nursing education: randomized controlled trial. J Med Internet Res. 2019;21(3):e11529–e. doi:10.2196/11529
   PubMed Web of Science ®Google Scholar
• De Freitas S, Rebolledo-Mendez G, Liarokapis F, Magoulas G, Poulovassilis A. Learning as immersive experiences: using the four-dimensional framework for designing and evaluating immersive learning experiences in a virtual world. Br J Educ Technol. 2010;41(1):69–85. doi:10.1111/j.1467-8535.2009.01024.x
   Web of Science ®Google Scholar
• Petit Dit Dariel OJ, Raby T, Ravaut F, Rothan-Tondeur M. Developing the Serious Games potential in nursing education. Nurse Educ Today. 2013;33(12):1569–1575. doi:10.1016/j.nedt.2012.12.014
   Web of Science ®Google Scholar
• Verkuyl M, Romaniuk D, Atack L, Mastrilli P. Virtual gaming simulation for Nursing education: an experiment. Clin Simul Nurs. 2017;13(5):238–244. doi:10.1016/j.ecns.2017.02.004
   Web of Science ®Google Scholar
• 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;15(1):46–54. doi:10.1097/SIH.0000000000000411
   Google Scholar
• Christopoulos A, Conrad M, Shukla M. Increasing student engagement through virtual interactions: how? Virtual Real. 2018;22(4):353–369. doi:10.1007/s10055-017-0330-3
   Web of Science ®Google Scholar
• Central statistical agency Ethiopian population and housing census report. Central Statistical Agency; 2007. Available from: http://www.csa.gov.et/census-report/complete-report/census-2007. Accessed March 3, 3022.
   Google Scholar
• Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. Am J Prev Med. 2009;36(5):452–457. doi:10.1016/j.amepre.2009.02.002
   PubMed Web of Science ®Google Scholar
• Fischer AJ, Dart EH, Leblanc H, Hartman KL, Steeves RO, Gresham FM. An investigation of the acceptability of videoconferencing within a school‐based behavioral consultation framework. Psychol Sch. 2016;53(3):240–252. doi:10.1002/pits.21900
   Web of Science ®Google Scholar
• Nadal C, Sas C, Doherty G. Technology acceptance in mobile health: scoping review of definitions, models, and measurement. J Med Internet Res. 2020;22(7):e17256. doi:10.2196/17256
   PubMed Web of Science ®Google Scholar
• Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. doi:10.1007/s10488-010-0319-7
   PubMed Web of Science ®Google Scholar
• Wallace LG, Sheetz SD. The adoption of software measures: a technology acceptance model (TAM) perspective. Inf Manag. 2014;51(2):249–259. doi:10.1016/j.im.2013.12.003
   Web of Science ®Google Scholar
• Embil JM, Albalawi Z, Bowering K, Trepman E. Foot Care. Can. 2018;42:S222–S7.
   Google Scholar
• INACSL Standards Committee. INACSL. Standards of best practice: simulationsm participant evaluation. Clin Simul Nurs. 2016;12:S26–S9. doi:10.1016/j.ecns.2016.09.009
   Web of Science ®Google Scholar
• International standards for education of diabetes health professionals [Internet]; 2015. Available from: https://www.idf.org/e-library/%20education/63-international-standards-for-education-of-diabetes-healthprofessionals.html. Accessed March 3, 3022.
   Google Scholar
• Hailu FB, Hjortdahl P, Moen A. Nurse-led diabetes self-management education improves clinical parameters in Ethiopia. Front Public Health. 2018;6(302). doi:10.3389/fpubh.2018.00302
   Web of Science ®Google Scholar
• Keys E, Luctkar-Flude M, Tyerman J, Sears K, Woo K. Developing a virtual simulation game for nursing resuscitation education. Clin Simul Nurs. 2020;39:51–54. doi:10.1016/j.ecns.2019.10.009
   Web of Science ®Google Scholar
• Luctkar-Flude M, Tyerman J, Ziegler E, et al. Developing a sexual orientation and gender identity nursing education toolkit. J Contin Educ Nurs. 2020;51(9):412–419. doi:10.3928/00220124-20200812-06
   Web of Science ®Google Scholar
• Zweben A, Fucito LM, O’Malley SS. Effective strategies for maintaining research participation in clinical trials. Drug Inf J. 2009;43(4):459–467. doi:10.1177/009286150904300411
   Google Scholar
• Zhang Y, Liu C, Luo S, et al. 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;21(8):e15023–e. doi:10.2196/15023
   PubMed Web of Science ®Google Scholar
• Wahr JA, Abernathy JH 3rd, Lazarra EH, et al. Medication safety in the operating room: literature and expert-based recommendations. Br J Anaesth. 2017;118(1):32–43. doi:10.1093/bja/aew379
   Web of Science ®Google Scholar
• Shahrabi MA, Ahaninjan A, Nourbakhsh H, Ashlubolagh MA, Abdolmaleki J, Mohamadi M. Assessing psychometric reliability and validity of Technology Acceptance Model (TAM) among faculty members at Shahid Beheshti University. Manag Sci Lett. 2013;3:2295–2300. doi:10.5267/j.msl.2013.07.014
   Google Scholar
• Isma B, Ahmad E, Ahlan AR. Reliability and validity of a questionnaire to evaluate diabetic patients’ intention to adopt health information technology: a pilot study. J Theor Appl Inf Technol. 2015;72:253–264
   Google Scholar
• Hailu M, Mammo Y, Ketema M. Internet acceptance and use model in Ethiopian agriculture education and research: the case of two universities. Int J Sci Technol Educ Res. 2016;7(4):35–48. doi:10.5897/IJSTER2016.0349
   Google Scholar
• Pollock RD, Unwin NC, Connolly V. Knowledge and practice of foot care in people with diabetes. Diabetes Res Clin Pract. 2004;64(2):117–122. doi:10.1016/j.diabres.2003.10.014
   PubMed Web of Science ®Google Scholar
• Indrayana S, Guo S-E, Lin C-L, Fang S-Y. Illness perception as a predictor of foot care behavior among people with type 2 diabetes mellitus in Indonesia. J Transcult Nurs. 2018;30(1):17–25. doi:10.1177/1043659618772347
   PubMed Web of Science ®Google Scholar
• Biçer EK, Enç N. Evaluation of foot care and self-efficacy in patients with diabetes in Turkey: an interventional study. Int J Diabetes Dev Ctries. 2016;36(3):334–344. doi:10.1007/s13410-016-0464-y
   Web of Science ®Google Scholar
• Biçer E, Enç N. Validity and reliability of the Turkish adaptation of the foot self care behaviour scale. Diyabet, Obezite ve Hipertansiyonda Hemsirelik Forumu Dergisi. 2014;6(2):35–39.
   Google Scholar
• Sloan HL. Developing and testing of the foot care confidence scale. J Nurs Meas. 2002;10(3):207–218. doi:10.1891/jnum.10.3.207.52564
   Google Scholar
• Billingham SAM, 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;13(1):104. doi:10.1186/1471-2288-13-104
   PubMed Web of Science ®Google Scholar
• Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012;65(3):301–308. doi:10.1016/j.jclinepi.2011.07.011
   PubMed Web of Science ®Google Scholar
• McCoy CE. Understanding the intention-to-treat principle in randomized controlled trials. West J Emerg Med. 2017;18(6):1075–1078. doi:10.5811/westjem.2017.8.35985
   PubMed Web of Science ®Google Scholar
• Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162. doi:10.1186/s12874-017-0442-1
   PubMed Web of Science ®Google Scholar
• Woo K. Polit & Beck: Canadian Essentials of Nursing Research. 4th ed. Philadelphia: Wolters Kluwer; 2019.
   Google Scholar
• Tavakol M, Dennick R. Making sense of Cronbach’s alpha. Int J Med Educ. 2011;2:53–55. doi:10.5116/ijme.4dfb.8dfd
   PubMedGoogle Scholar
• Vaismoradi M, Turunen H, Bondas T. Content analysis and thematic analysis: implications for conducting a qualitative descriptive study. Nurs Health Sci. 2013;15(3):398–405. doi:10.1111/nhs.12048
   PubMed Web of Science ®Google Scholar
• Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs. 2008;62(1):107–115. doi:10.1111/j.1365-2648.2007.04569.x
   PubMed Web of Science ®Google Scholar
• Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014;6(1):103–109. doi:10.4055/cios.2014.6.1.103
   PubMedGoogle Scholar
• Dettori J. The random allocation process: two things you need to know. Evid Based Spine Care J. 2010;1(3):7–9. doi:10.1055/s-0030-1267062
   PubMedGoogle Scholar
• Haag U. Technologies for automating randomized treatment assignment in clinical trials. Drug Inf J. 1998;32(1):7–11. doi:10.1177/009286159803200102
   Google Scholar
• Torgerson DJ, Roberts C. Understanding controlled trials concealment. BMJ. 1999;319(7206):375–376.
   Web of Science ®Google Scholar
• Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behavior Med. 2003;25(3):182–193. doi:10.1207/S15324796ABM2503_04
   PubMed Web of Science ®Google Scholar